|
1
|
Yew KC, Sim ASY, Hawkins R, Acharyya S, Wong GD, Wong SWC, Lim YH, Yang WL, Lim WY, Chow ALP. Real-World Evaluation of Point-of-Care Testing for Hepatitis C Antibodies: Navigating Hepatitis C Elimination Effort. J Viral Hepat 2025; 32:e14039. [PMID: 39575764 DOI: 10.1111/jvh.14039] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/24/2024] [Revised: 09/27/2024] [Accepted: 11/05/2024] [Indexed: 04/27/2025]
Abstract
An HCV elimination program aims to diagnose more than 90% of Chronic HCV cases. We critically evaluated the performance of a point-of-care test (POCT) using an HCV Rapid Antibody Test. PWID from 4 Halfway Houses (HWH) in Singapore were recruited from March 2022 to April 2023. Participants were concurrently screened for HCV via venous blood for anti-HCV serology and using fingerstick capillary whole blood (FSWB) and oral mucosal transudates (OMT) for POCT, which were interpreted by trained personnel. A blinded study team member independently assessed images of POCTs. Of 207 participants, 37.3% were anti-HCV positive. Compared to anti-HCV serology, POCT performance on FSWB and OMT were: Sensitivity 81.8 (73.2-90.4), 74.0 (64.2-83.8), p = 0.014; Specificity 100.0 (100.0-100.0), 98.5 (96.3-100), p = 0.157. Sub-group analysis of strict 30-min pre-test nil-by-mouth instruction in 103 subjects reported Sensitivity 77.5 (64.6-90.4), 77.5 (64.6-90.4) and Specificity 100.0 (100.0-100.0) and 98.4 (95.3-100.0). OMT positivity and false-negative outcomes did not correlate with the sample analytical cutoff index signal distribution of anti-HCV Serology. Inter-class correlation between real-time and imaging readings of POCT for FSWB and OMT at 20 and 40 min were Kappa 0.9666, 0.9674; 0.8803, 0.8940. Proper preparation and patient selection enhance test performance. Differences in oral fluid immunoglobulin secretion, oral pathology, age, and sample collection can affect POCT OMT readings. POCT OMT is promising in serial and self-testing, complementing its convenience in testing.
Collapse
Affiliation(s)
- Kuo Chao Yew
- Department of Gastroenterology & Hepatology, Tan Tock Seng Hospital, Singapore, Singapore
| | - Alyssa Shin Yee Sim
- Department of Gastroenterology & Hepatology, Tan Tock Seng Hospital, Singapore, Singapore
| | - Robert Hawkins
- Department of Laboratory Medicine, Tan Tock Seng Hospital, Singapore, Singapore
| | - Sanchalika Acharyya
- Clinical Research & Innovation Office, Tan Tock Seng Hospital, Singapore, Singapore
| | - Gerard Daquan Wong
- HCSA Highpoint Halfway House, HCSA Community Services, Singapore, Singapore
| | | | - Yuan Heng Lim
- Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore
| | - Wei Lyn Yang
- Department of Gastroenterology & Hepatology, Tan Tock Seng Hospital, Singapore, Singapore
| | - Wei-Yen Lim
- Department of Preventive and Population Medicine, Tan Tock Seng Hospital, Singapore, Singapore
| | - Angela Li Ping Chow
- Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore
- Department of Preventive and Population Medicine, Tan Tock Seng Hospital, Singapore, Singapore
| |
Collapse
|
|
2
|
Albertos S, Majo FX, Esteban R, Colom J, Buti M. A large-scale screening of hepatitis C among men who have sex with men in the community using saliva point-of-care testing. Front Public Health 2024; 12:1478195. [PMID: 39717035 PMCID: PMC11663926 DOI: 10.3389/fpubh.2024.1478195] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/09/2024] [Accepted: 10/28/2024] [Indexed: 12/25/2024] Open
Abstract
Aim To assess the feasibility and acceptability of massive hepatitis C virus (HCV) testing in point of care on the street using quick tests, determine the characteristics of the population included, and the prevalence of HCV infection in this population. Methods Cross-sectional community-based study including adult men who have sex with men (MSM) who attended the three most important LGTB+ events in Sitges (Catalonia, Spain) in 2022. Points of care were set up on tents on the street and attendees were offered voluntary anti-HCV antibody self-testing. Participants were informed of the study, provided consent, completed the test for identification of risk practices (TIRP), and took the test with the OraQuick® HCV test on a saliva sample (sensitivity: 97.8% [95% confidence interval (CI), 93.2-99.4%] and specificity: 100% [95% CI, 98.4-100%]; gold standard: IgG antibody test for HCV by immunoassay [serum]); participants with positive results were offered HCV virus testing with the Xpert HCV Fingerstick® on a blood drop. Results A total of 1249 adults participated in the large-scale screening, of which 1197 (95.8%) were identified as MSM. The screening time was 39 participants/h. Four (0.32%) participants had positive anti-HCV results, all with undetectable HCV RNA levels. Participants' median (IQR) age was 44 (35, 54) years; most were Europeans, and 13% reported being unaware of their serological HCV status. The mean (SD) TIRP score was 1.40 (1.44) (n = 1062), with 67.41% reporting some risk, and the self-perceived sexually transmitted disease score was 3.0 (2.82) (n = 969). Conclusion The point-of-care strategy on the street using a quick oral self-test at massive MSM events is feasible, well-accepted, and quick, and may be a useful strategy to reach other populations at risk of HCV infection.
Collapse
Affiliation(s)
- Sonia Albertos
- Division of Gastroenterology and Hepatology, Hospital Residencia Sant Camil, Consorci Sanitari de l’Alt Penedès i Garraf (CSAPG), Barcelona, Spain
| | - Francesc X. Majo
- Catalunya Healthcare System, Generalitat de Catalunya, Prevenció, Control i Atenció al VIH, les ITS i les Hepatitis Víriques, Barcelona, Spain
| | - Rafael Esteban
- Department of Internal Medicine, Hospital Quiron, Barcelona, Spain
| | - Joan Colom
- Catalunya Healthcare System, Generalitat de Catalunya, Prevenció, Control i Atenció al VIH, les ITS i les Hepatitis Víriques, Barcelona, Spain
| | - María Buti
- Liver Unit, Internal Medicine Department, Hospital Universitari Vall d’Hebron, Barcelona, Spain
- Universitat Autònoma de Barcelona, Barcelona, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
| |
Collapse
|
|
3
|
Avramovic G, O’Doherty L, McHugh T, Remy AJ, Happiette A, Bouchkira H, Murat P, Scemama O, Esclade A, Farfan Camacho MI, Cullen W, Lambert JS. Benchmarking of an Intervention Aiming at the Micro-Elimination of Hepatitis C in Vulnerable Populations in Perpignan, France, to Inform Scale-Up and Elimination on the French Territory. Viruses 2024; 16:1645. [PMID: 39459977 PMCID: PMC11512308 DOI: 10.3390/v16101645] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/08/2024] [Revised: 10/14/2024] [Accepted: 10/16/2024] [Indexed: 10/28/2024] Open
Abstract
Hepatitis C virus (HCV) is an important cause of chronic liver disease. Among at-risk populations, access to care is challenging. The French Ministry of Health has supported a seek-and-treat pilot intervention aiming at micro-elimination in Perpignan, France, to inform scale-up of elimination efforts across the whole territory. University College Dublin (UCD) led a successful EU funded project, called HepCare, focusing on the micro-elimination of HCV. UCD was contracted to evaluate and benchmark the Perpignan results against results from HepCare. Using mixed-method approaches including qualitative interviews with patients, a focus group with healthcare professionals, and quantitative analyses of the cascade of care against results obtained at other European sites, we analyse the acceptability, reproducibility, replicability, and effectiveness of the Perpignan intervention. A total of 960 participants were recruited in the Perpignan area. HCV antibody test results were obtained for 928 (96.6%), of which 150 (15.6%) were antibody-positive. Of the antibody-positive participants, 68 (45.3%) tested positive for HCV-RNA, 141 (94%) were linked to care, and of the HCV-RNA-positive participants, 60 (88%) started treatment. Of those who underwent treatment, 34 (56.7%) completed treatment and achieved a sustained viral response (SVR) at dataset closure, 18 (30%) were still in treatment, 5 (8.3%) defaulted from treatment, and 3 (5%) had a virologic failure or died. The intervention in Perpignan was acceptable to patients, but had limitations in effectiveness, as shown in comparisons with HepCare results. To engage harder-to-reach cohorts in France, future models of care in the territory should incorporate peer support.
Collapse
Affiliation(s)
- Gordana Avramovic
- Mater Misericordiae University Hospital, 44 Eccles St, D07 R2WY Dublin, Ireland; (G.A.)
- Catherine McAuley Centre, University College Dublin, 21 Nelson St, D07 A8NN Dublin, Ireland
| | - Laura O’Doherty
- Mater Misericordiae University Hospital, 44 Eccles St, D07 R2WY Dublin, Ireland; (G.A.)
- Catherine McAuley Centre, University College Dublin, 21 Nelson St, D07 A8NN Dublin, Ireland
| | - Tina McHugh
- Mater Misericordiae University Hospital, 44 Eccles St, D07 R2WY Dublin, Ireland; (G.A.)
| | - Andre Jean Remy
- Centre Hospitalier de Perpignan-20 Avenue du Languedoc, 66046 Perpignam, France (A.H.)
| | - Arnaud Happiette
- Centre Hospitalier de Perpignan-20 Avenue du Languedoc, 66046 Perpignam, France (A.H.)
| | - Hakim Bouchkira
- Centre Hospitalier de Perpignan-20 Avenue du Languedoc, 66046 Perpignam, France (A.H.)
| | - Philippe Murat
- Ministère de la Santé et de la Prévention, 14, Avenue Duquesne, 75007 Paris, France
| | - Olivier Scemama
- Ministère de la Santé et de la Prévention, 14, Avenue Duquesne, 75007 Paris, France
| | - Adrien Esclade
- Ministère de la Santé et de la Prévention, 14, Avenue Duquesne, 75007 Paris, France
| | - Maria Isabel Farfan Camacho
- European Commission, Directorate-General for Structural Reform Support, CHARL 9/100, B-1049 Brussels, Belgium
| | - Walter Cullen
- Catherine McAuley Centre, University College Dublin, 21 Nelson St, D07 A8NN Dublin, Ireland
| | - John S. Lambert
- Mater Misericordiae University Hospital, 44 Eccles St, D07 R2WY Dublin, Ireland; (G.A.)
- Catherine McAuley Centre, University College Dublin, 21 Nelson St, D07 A8NN Dublin, Ireland
| |
Collapse
|
|
4
|
Mak LY, To WP, Tsui V, Chung MSH, Hui KY, Wu TKH, Kwok A, Ko KL, Wong DKH, Wong SY, Liu KSH, Seto WK, Yuen MF. Pilot model of hepatitis C virus micro-elimination in high-risk populations in Hong Kong: Barriers and facilitators. THE INTERNATIONAL JOURNAL OF DRUG POLICY 2024; 132:104568. [PMID: 39216456 DOI: 10.1016/j.drugpo.2024.104568] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/13/2024] [Revised: 08/14/2024] [Accepted: 08/15/2024] [Indexed: 09/04/2024]
Abstract
BACKGROUND Although the general seroprevalence of hepatitis C virus (HCV) infection in Hong Kong is <0.5 %, Hong Kong is still striving for HCV elimination owing to barriers in care cascade encompassing linkage-to-care (LTC), treatment initiation and adherence. We aimed to evaluate the feasibility of a pilot model of micro-elimination to strengthen the HCV care cascade for high-risk groups in Hong Kong. METHODS We initiated the pilot Conquering Hepatitis vIa Micro-Elimination (CHIME) program which adopts an integrated care approach involving outreach visits to halfway house or drug rehabilitation centers run by non-governmental organizations. Participants with history of injection drug use (PWID), recreational drug use, or imprisonment were included. We performed point-of-care test for anti-HCV with reflex HCV RNA testing. LTC with government-subsidized direct acting antiviral was provided to viremic participants. We compared the impact on the care cascade with a cohort of HCV patients (17.8 % PWID) under usual care. RESULTS 396 participants (62.9 % PWID) were screened and 187 (47.2 %) were viremic, of which 29.8 % had cirrhosis. Proportion with LTC, treatment initiation and adherence were 76.5 % and 63.7 %, 90.9 % and 85.8 %, and 90.0 % and 92.2 %, for the CHIME program and usual care, respectively. The CHIME program was significantly associated with higher odds of LTC (OR 1.797, 95 % CI 1.221-2.644). Non-engagement in care (affecting 37.9 % participants with HCV viremia) was associated with unemployment (OR 2.165, 95 % CI 1.118-4.190). CONCLUSION The pilot CHIME program demonstrated feasibility of an integrated approach to consolidate the HCV care cascade in high-risk populations in Hong Kong.
Collapse
Affiliation(s)
- Lung-Yi Mak
- Department of Medicine, Queen Mary Hospital, The University of Hong Kong; State Key Laboratory of Liver Research, The University of Hong Kong, Hong Kong
| | - Wai-Pan To
- Department of Medicine, Queen Mary Hospital, The University of Hong Kong
| | - Vivien Tsui
- Department of Medicine, Queen Mary Hospital, The University of Hong Kong
| | | | - Ka-Yin Hui
- Department of Medicine, Queen Mary Hospital, The University of Hong Kong
| | | | - Anthony Kwok
- Department of Medicine, Queen Mary Hospital, The University of Hong Kong
| | - Kwan-Lung Ko
- Department of Medicine, Queen Mary Hospital, The University of Hong Kong
| | - Danny Ka-Ho Wong
- Department of Medicine, Queen Mary Hospital, The University of Hong Kong; State Key Laboratory of Liver Research, The University of Hong Kong, Hong Kong
| | - Siu-Yin Wong
- Department of Medicine, Queen Mary Hospital, The University of Hong Kong
| | - Kevin Sze-Hang Liu
- Department of Medicine, Queen Mary Hospital, The University of Hong Kong
| | - Wai-Kay Seto
- Department of Medicine, Queen Mary Hospital, The University of Hong Kong; State Key Laboratory of Liver Research, The University of Hong Kong, Hong Kong
| | - Man-Fung Yuen
- Department of Medicine, Queen Mary Hospital, The University of Hong Kong; State Key Laboratory of Liver Research, The University of Hong Kong, Hong Kong.
| |
Collapse
|
|
5
|
Conway B, Yi S, Yung R, Sharma S. GRAND PLAN: Safety and Efficacy of Glecaprevir/Pibrentasvir for the Treatment of Hepatitis C Virus Infection Among People Initially Disengaged From Health Care Who Use Drugs-A Systematic Multidisciplinary Approach. Open Forum Infect Dis 2024; 11:ofad638. [PMID: 38444819 PMCID: PMC10914366 DOI: 10.1093/ofid/ofad638] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/02/2023] [Indexed: 03/07/2024] Open
Abstract
Background GRAND PLAN is a prospective, open-label, phase 4 study. Based at a single center and with a single arm, GRAND PLAN evaluated the safety and efficacy of an 8-week course of glecaprevir/pibrentasvir (G/P) among active drug users with hepatitis C virus (HCV) infection in a population enriched for factors that may reduce treatment uptake and success, such as disengagement from health care and unstable housing. Methods Participants were ≥19 years old and actively using drugs and were confirmed viremic, noncirrhotic, and HCV treatment naive. All participants provided informed consent before any study procedures. They received G/P for 8 weeks within a multidisciplinary model of care, with daily, weekly, or monthly dispensing of medications to optimize adherence. Results We identified 117 eligible patients with a median age of 46 years (range, 22-75): 27% were female, 21.4% were Indigenous, 48.7% were unstably housed, and 95.7% were active drug users (94.9% fentanyl). One patient did not start treatment, and 4 underwent <1 week of treatment, leaving 112 completed treatments with 94.6% picking up medications weekly. HCV RNA was undetectable at the end of treatment in all 112 patients. One died of unknown causes shortly after treatment. A cure was demonstrated in 108 of 111 (97.3%) cases at the SVR12 time point (sustained virologic response at ≥12 weeks); the other 3 experienced virologic relapse. Considering the entire cohort, the intent-to-treat success rate was 92.3% (108/117). HCV reinfection was documented at SVR24 in 5 cases, 2 of which were successfully retreated. Conclusions GRAND PLAN demonstrates that administration of an 8-week course of G/P to inner-city residents with HCV infection leads to a cure >95%. With a short course of treatment, G/P is an attractive option for this population in helping us achieve the World Health Organization's HCV objectives by 2030.
Collapse
Affiliation(s)
- Brian Conway
- Vancouver Infectious Diseases Center, Vancouver, British Columbia, Canada
- Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada
| | - Shana Yi
- Vancouver Infectious Diseases Center, Vancouver, British Columbia, Canada
| | - Rossitta Yung
- Vancouver Infectious Diseases Center, Vancouver, British Columbia, Canada
| | - Shawn Sharma
- Vancouver Infectious Diseases Center, Vancouver, British Columbia, Canada
| |
Collapse
|
|
6
|
Taha G, Ezra L, Abu-Freha N. Hepatitis C Elimination: Opportunities and Challenges in 2023. Viruses 2023; 15:1413. [PMID: 37515101 PMCID: PMC10386528 DOI: 10.3390/v15071413] [Citation(s) in RCA: 17] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/19/2023] [Revised: 06/08/2023] [Accepted: 06/20/2023] [Indexed: 07/30/2023] Open
Abstract
Hepatitis C Virus (HCV) infection is a leading etiology of liver cirrhosis and its associated complications, namely, decompensated cirrhosis. As such, hepatitis C potentially necessitates liver transplantation and may result in death. Recently, HCV treatment has evolved. Current HCV treatment is effective in curing HCV; some of the agents are pan-genotypic. Numerous countries have adopted an initiative to eliminate HCV. Achieving elimination poses many challenges; it requires improved availability and accessibility of pan-genotypic therapy. Barriers exist at the level of the collective healthcare system and at the level of the individual healthcare providers and patients. Therefore, organized national and local efforts are needed. Surmounting these barriers calls for interventions concerning screening, linkage to care, and treatment delivery. Pertinent barriers include inadequate availability of screening, ill-equipped laboratory testing before treatment, and insufficient access to treatment. Interventions should seek to decentralize laboratory testing and treatment provision, increase funding for resources and personnel, and spread awareness. Special consideration should be allocated to at-risk populations, such as intravenous drug users, refugees, and prisoners. Computerized medical filing and telemedicine have the potential to refine HCV management by enhancing detection, availability, accessibility, and cost-effectiveness.
Collapse
Affiliation(s)
- Gadeer Taha
- Department of Gastroenterology, Rambam Health Care Campus, Haifa 31096, Israel
| | - Levy Ezra
- Medical School for International Health, Ben-Gurion University of the Negev, Beer-Sheva 84101, Israel
| | - Naim Abu-Freha
- Institute of Gastroenterology and Hepatology, Soroka University Medical Center, Beer-Sheva 84101, Israel
- Faculty of Health Sciences, Ben Gurion University of the Negev, Beer-Sheva 84105, Israel
| |
Collapse
|
|
7
|
Kumari S, Samara M, Ampadi Ramachandran R, Gosh S, George H, Wang R, Pesavento RP, Mathew MT. A Review on Saliva-Based Health Diagnostics: Biomarker Selection and Future Directions. BIOMEDICAL MATERIALS & DEVICES (NEW YORK, N.Y.) 2023:1-18. [PMID: 37363139 PMCID: PMC10243891 DOI: 10.1007/s44174-023-00090-z] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 03/30/2023] [Accepted: 05/12/2023] [Indexed: 06/28/2023]
Abstract
The human body has a unique way of saying when something is wrong with it. The molecules in the body fluids can be helpful in the early detection of diseases by enabling health and preventing disease progression. These biomarkers enabling better healthcare are becoming an extensive area of research interest. Biosensors that detect these biomarkers are becoming the future, especially Point Of Care (POC) biosensors that remove the need to be physically present in the hospital. Detection of complex and systemic diseases using biosensors has a long way to go. Saliva-based biosensors are gaining attention among body fluids due to their non-invasive collection and ability to detect periodontal disease and identify systemic diseases. The possibility of saliva-based diagnostic biosensors has gained much publicity, with companies sending home kits for ancestry prediction. Saliva-based testing for covid 19 has revealed effective clinical use and relevance of the economic collection. Based on universal biomarkers, the detection of systemic diseases is a booming research arena. Lots of research on saliva-based biosensors is available, but it still poses challenges and limitations as POC devices. This review paper talks about the relevance of saliva and its usefulness as a biosensor. Also, it has recommendations that need to be considered to enable it as a possible diagnostic tool. Graphical Abstract
Collapse
Affiliation(s)
- Swati Kumari
- Department of Restorative Dentistry, College of Dentistry, University of Illinois at Chicago, Chicago, IL USA
| | - Mesk Samara
- Department of Restorative Dentistry, College of Dentistry, University of Illinois at Chicago, Chicago, IL USA
| | | | - Sujoy Gosh
- Department of Restorative Dentistry, College of Dentistry, University of Illinois at Chicago, Chicago, IL USA
| | - Haritha George
- Department of Biomedical Engineering, University of Illinois at Chicago, Chicago, IL USA
| | - Rong Wang
- Department of Biological and Chemical Sciences, Illinois Institute of Technology, Chicago, IL USA
| | - Russell P. Pesavento
- Department of Oral Biology, College of Dentistry, University of Illinois at Chicago, Chicago, IL USA
| | - Mathew T. Mathew
- Department of Restorative Dentistry, College of Dentistry, University of Illinois at Chicago, Chicago, IL USA
- Department of Biomedical Engineering, University of Illinois at Chicago, Chicago, IL USA
| |
Collapse
|
|
8
|
Colón-López V, Alvelo-Fernández PM, Centeno-Alvarado N, Agudelo Salas IY, Rolón Colón Y, Pabón Martínez M, Rodríguez-Lebrón JL, Reyes-Pulliza JC. Seroprevalence and risk factors associated with hepatitis C: a cross-sectional study of persons who inject drugs in Puerto Rico, 2018. BMC Public Health 2023; 23:704. [PMID: 37072733 PMCID: PMC10111640 DOI: 10.1186/s12889-023-15341-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/28/2022] [Accepted: 02/28/2023] [Indexed: 04/20/2023] Open
Abstract
BACKGROUND People Who Inject Drugs (PWID) are at a higher risk of acquiring bloodborne infections. We aimed to estimate the seroprevalence of the Hepatitis C Virus (HCV) in PWID and identify correlates and risk factors using data from the Puerto Rico National HIV Behavioral Surveillance System, PWID cycle 5, conducted in 2018. METHODS A total of 502 San Juan Metropolitan Statistical Area participants were recruited through the Respondent Driven Sampling method. Sociodemographic, health-related, and behavioral characteristics were assessed. Testing for HCV antibodies was completed after the face-to-face survey. Descriptive and logistic regression analyses were performed. RESULTS Overall seroprevalence of HCV was 76.5% (95% CI: 70.8-81.4%). A significantly (p < 0.05) higher HCV seroprevalence was observed among PWID with the following characteristics: heterosexuals (78.5%), high school graduates (81.3%), tested for sexually transmitted infections (STI) in the past 12 months (86.1%), frequent speedball injection (79.4%), and knowing the HCV serostatus of the last sharing partner (95.4%). Adjusted logistic regression models showed that having completed high school and reported STI testing in the past 12 months were significantly associated with HCV infection (ORa = 2.23; 95% CI: 1.06-4.69; ORa = 2.14; 95% CI: 1.06-4.30, respectively). CONCLUSIONS We report a high seroprevalence of HCV infection in PWID. Social health disparities and potential missed opportunities validate the continuing call for local action for public health and prevention strategies.
Collapse
Affiliation(s)
- Vivian Colón-López
- Cancer Control and Population Sciences Program, University of Puerto Rico Comprehensive Cancer Center, Primer Piso Oficina #151 Paseo José C. Barbosa San Juan, San Juan, 00935, Puerto Rico.
| | - Paola M Alvelo-Fernández
- Cancer Control and Population Sciences Program, University of Puerto Rico Comprehensive Cancer Center, Primer Piso Oficina #151 Paseo José C. Barbosa San Juan, San Juan, 00935, Puerto Rico
| | - Nadia Centeno-Alvarado
- Graduate School of Public Health, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico
| | - Ivony Y Agudelo Salas
- Graduate School of Public Health, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico
| | - Yadira Rolón Colón
- HIV/AIDS Surveillance Program, Puerto Rico Department of Health, San Juan, Puerto Rico
| | - María Pabón Martínez
- HIV/AIDS Surveillance Program, Puerto Rico Department of Health, San Juan, Puerto Rico
| | | | - Juan C Reyes-Pulliza
- Department of Biostatistics and Epidemiology, Graduate School of Public Health, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico
| |
Collapse
|
|
9
|
Siegele-Brown C, Siegele-Brown M, Cook C, Khakoo SI, Parkes J, Wright M, Buchanan RM. Testing to sustain hepatitis C elimination targets in people who inject drugs: A network-based model. J Viral Hepat 2023; 30:242-249. [PMID: 36529668 DOI: 10.1111/jvh.13786] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/26/2022] [Accepted: 12/03/2022] [Indexed: 01/14/2023]
Abstract
Little is known about the level of testing required to sustain elimination of hepatitis C (HCV), once achieved. In this study, we model the testing coverage required to maintain HCV elimination in an injecting network of people who inject drugs (PWID). We test the hypothesis that network-based strategies are a superior approach to deliver testing. We created a dynamic injecting network structure connecting 689 PWID based on empirical data. The primary outcome was the testing coverage required per month to maintain prevalence at the elimination threshold over 5 years. We compared four testing strategies. Without any testing or treatment provision, the prevalence of HCV increased from the elimination threshold (11.68%) to a mean of 25.4% (SD 2.96%) over the 5-year period. To maintain elimination with random testing, on average, 4.96% (SD 0.83%) of the injecting network needs to be tested per month. However, with a 'bring your friends' strategy, this was reduced to 3.79% (SD 0.64%) of the network (p < .001). The addition of contact tracing improved the efficiency of both strategies. In conclusion, we report that network-based approaches to testing such as 'bring a friend' initiatives and contact tracing lower the level of testing coverage required to maintain elimination.
Collapse
Affiliation(s)
- Chloë Siegele-Brown
- Faculty of Medicine, University of Southampton, Southampton, UK.,University Hospital Southampton, Southampton, UK
| | | | - Charlotte Cook
- Faculty of Medicine, University of Southampton, Southampton, UK
| | - Salim I Khakoo
- Faculty of Medicine, University of Southampton, Southampton, UK
| | - Julie Parkes
- Faculty of Medicine, University of Southampton, Southampton, UK
| | - Mark Wright
- University Hospital Southampton, Southampton, UK
| | - Ryan M Buchanan
- Faculty of Medicine, University of Southampton, Southampton, UK.,NIHR Southampton Biomedical Research Centre, Southampton, UK
| |
Collapse
|
|
10
|
Foster MA, Moorman AC, Teshale EH. Hepatitis C Virus. PRINCIPLES AND PRACTICE OF PEDIATRIC INFECTIOUS DISEASES 2023:1156-1160.e3. [DOI: 10.1016/b978-0-323-75608-2.00220-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/04/2025]
|
|
11
|
Becker SCDC, Medina-Pestana JO, Canziani MEF, Souza ALS, Amaral AC, Vieira GA, Ferraz ML. Performance of rapid test for antibodies to hepatitis C virus (anti-HCV) in hemodialysis patients and kidney transplant recipients. Int J Artif Organs 2022; 45:680-684. [PMID: 35751365 DOI: 10.1177/03913988221104834] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
Rapid tests (RT) have been widely used for screening of hepatitis C virus (HCV) in general population, but its performance in hemodialysis (HD) patients and mainly in kidney-transplant recipients (RTx) is less known. The aim of this study was to evaluate the accuracy of RT for detection of anti-HCV in HD and RTx patients. Patients were prospectively included subdivided in four groups according to the positivity for anti-HCV detected by conventional serology: (1) HD patients anti-HCV +, (2) HD patients anti-HCV -, (3) RTx patients anti-HCV +, and (4) RTx patients anti-HCV -. All patients were retested for HCV using the commercial kit Alere HCV® Bioeasy Rapid Test (Bioeasy Diagnóstica LTDA-Minas Gerais, Brazil) in capillary whole blood samples. During the period of study were included 46 HD patients anti-HCV+, 62 HD patients anti-HCV -, 53 RTx patients anti-HCV + and 56 RTx patients anti-HCV -. In patients on HD, the RT showed sensitivity (S), specificity (SP), positive predictive value (PPV), negative predictive value (NPV), and accuracy of 100%. In RTx patients, S of 96%, SP of 100%, PPV of 100% and NPV of 97% were found (accuracy of 98%). In conclusion, in patients on HD there was 100% agreement between RT and the conventional immunoassay. In the RTx group, although the agreement was not 100%, the RT performed very well when compared to conventional serology. This study demonstrates that the RT can be an alternative to conventional serology in HCV screening of patients on HD and RTx.
Collapse
Affiliation(s)
| | | | | | | | - Ana Cristina Amaral
- Division of Gastroenterology, Federal University of São Paulo, Sao Paulo, Brazil
| | | | - Maria Lucia Ferraz
- Division of Gastroenterology, Federal University of São Paulo, Sao Paulo, Brazil
| |
Collapse
|
|
12
|
Kamis KF, Wyles DL, Minturn MS, Scott T, McEwen D, Hurley H, Prendergast SJ, Rowan SE. Hepatitis C Testing and Linkage to Care Among Adults on Probation in a Large US City. Open Forum Infect Dis 2021; 9:ofab636. [PMID: 35111867 PMCID: PMC8802802 DOI: 10.1093/ofid/ofab636] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/23/2021] [Accepted: 12/15/2021] [Indexed: 12/09/2022] Open
Abstract
Background Despite constituting the largest segment of the correctional population, individuals on probation remain largely unstudied with respect to hepatitis C virus (HCV) testing and linkage to care. We implemented an HCV testing and patient navigation program at an adult probation department. Methods Adults were tested at a local probation department with a rapid point-of-care HCV antibody (Ab) assay followed by a laboratory-based HCV ribonucleic acid (RNA) assay if anti-HCV positive. All individuals received counseling rooted in harm reduction principles. Individuals testing positive for HCV Ab were immediately linked to a patient navigator in person or via telephone. The patient navigator assisted patients through cure unless the patient was lost to follow-up. Study participation involved an optional survey and optional point-of-care human immunodeficiency virus test. Results Of 417 individuals tested, 13% were HCV Ab positive and 65% of those tested for HCV RNA (34 of 52) had detectable HCV RNA. Of the 14 individuals who linked to an HCV treatment provider, 4 completed treatment, as measured by pharmacy fill documentation in the electronic medical record, and 1 obtained sustained virologic response. One hundred ninety-three individuals tested for HIV; none tested positive. Conclusions The study cohort had a higher HCV seroprevalence than the general population (13% vs 2%), but linkage to care, completion of HCV treatment, and successful test-of-cure rates were all low. This study indicates that HCV disproportionately impacts adults on probation and prioritizing support for testing and linkage to care could improve health in this population. Colocalization of HCV treatment within probation programs would reduce the barrier of attending a new institution and could be highly impactful.
Collapse
Affiliation(s)
- Kevin F Kamis
- Public Health Institute at Denver Health, Denver Health and Hospital Authority, Denver, Colorado, USA
| | - David L Wyles
- Division of Infectious Diseases, Denver Health Medical Center and University of Colorado School of Medicine, Denver, Colorado, USA
| | - Matthew S Minturn
- Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA
| | - Tracy Scott
- LGBTQ+ Health Services, Denver Health and Hospital Authority, Denver, Colorado, USA
| | - Dean McEwen
- Public Health Institute at Denver Health, Denver Health and Hospital Authority, Denver, Colorado, USA
| | - Hermione Hurley
- Public Health Institute at Denver Health, Denver Health and Hospital Authority, Denver, Colorado, USA
- Division of Infectious Diseases, Denver Health Medical Center and University of Colorado School of Medicine, Denver, Colorado, USA
- Center for Addiction Medicine, Denver Health and Hospital Authority, Denver, Colorado, USA
| | | | - Sarah E Rowan
- Public Health Institute at Denver Health, Denver Health and Hospital Authority, Denver, Colorado, USA
- Division of Infectious Diseases, Denver Health Medical Center and University of Colorado School of Medicine, Denver, Colorado, USA
| |
Collapse
|
|
13
|
Tobin E, Brenner S. Nanotechnology Fundamentals Applied to Clinical Infectious Diseases and Public Health. Open Forum Infect Dis 2021; 8:ofab583. [PMID: 34988245 PMCID: PMC8694202 DOI: 10.1093/ofid/ofab583] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/23/2021] [Accepted: 11/16/2021] [Indexed: 12/18/2022] Open
Abstract
Nanotechnology involves the discovery and fabrication of nanoscale materials possessing unique physicochemical properties that are being employed in industry and medicine. Infectious Diseases clinicians and public health scientists utilize nanotechnology applications to diagnose, treat, and prevent infectious diseases. However, fundamental principles of nanotechnology are often presented in technical formats that presuppose an advanced knowledge of chemistry, physics, and engineering, thereby limiting the clinician’s grasp of the underlying science. While nanoscience is technically complex, it need not be out of reach of the clinical practitioner. The aim of this review is to introduce fundamental principles of nanotechnology in an accessible format, describe examples of current clinical infectious diseases and public health applications, and provide a foundation that will aid understanding of and appreciation for this burgeoning and important field of science.
Collapse
Affiliation(s)
- Ellis Tobin
- College of Nanoscale Science and Engineering, State University of New York Polytechnic Institute, Albany, New York, USA
| | - Sara Brenner
- Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, USA
| |
Collapse
|
|
14
|
Shahid I, Alzahrani AR, Al-Ghamdi SS, Alanazi IM, Rehman S, Hassan S. Hepatitis C Diagnosis: Simplified Solutions, Predictive Barriers, and Future Promises. Diagnostics (Basel) 2021; 11:1253. [PMID: 34359335 PMCID: PMC8305142 DOI: 10.3390/diagnostics11071253] [Citation(s) in RCA: 16] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/30/2021] [Revised: 07/02/2021] [Accepted: 07/05/2021] [Indexed: 12/14/2022] Open
Abstract
The simplification of current hepatitis C diagnostic algorithms and the emergence of digital diagnostic devices will be very crucial to achieving the WHO's set goals of hepatitis C diagnosis (i.e., 90%) by 2030. From the last decade, hepatitis C diagnosis has been revolutionized by the advent and approval of state-of-the-art HCV diagnostic platforms which have been efficiently implemented in high-risk HCV populations in developed nations as well as in some low-to-middle income countries (LMICs) to identify millions of undiagnosed hepatitis C-infected individuals. Point-of-care (POC) rapid diagnostic tests (RDTs; POC-RDTs), RNA reflex testing, hepatitis C self-test assays, and dried blood spot (DBS) sample analysis have been proven their diagnostic worth in real-world clinical experiences both at centralized and decentralized diagnostic settings, in mass hepatitis C screening campaigns, and hard-to-reach aboriginal hepatitis C populations in remote areas. The present review article overviews the significance of current and emerging hepatitis C diagnostic packages to subvert the public health care burden of this 'silent epidemic' worldwide. We also highlight the challenges that remain to be met about the affordability, accessibility, and health system-related barriers to overcome while modulating the hepatitis C care cascade to adopt a 'test and treat' strategy for every hepatitis C-affected individual. We also elaborate some key measures and strategies in terms of policy and progress to be part of hepatitis C care plans to effectively link diagnosis to care cascade for rapid treatment uptake and, consequently, hepatitis C cure.
Collapse
Affiliation(s)
- Imran Shahid
- Department of Pharmacology and Toxicology, Faculty of Medicine, Umm Al-Qura University, Al-Abidiyah, P.O. Box 13578, Makkah 21955, Saudi Arabia; (A.R.A.); (S.S.A.-G.); (I.M.A.)
| | - Abdullah R. Alzahrani
- Department of Pharmacology and Toxicology, Faculty of Medicine, Umm Al-Qura University, Al-Abidiyah, P.O. Box 13578, Makkah 21955, Saudi Arabia; (A.R.A.); (S.S.A.-G.); (I.M.A.)
| | - Saeed S. Al-Ghamdi
- Department of Pharmacology and Toxicology, Faculty of Medicine, Umm Al-Qura University, Al-Abidiyah, P.O. Box 13578, Makkah 21955, Saudi Arabia; (A.R.A.); (S.S.A.-G.); (I.M.A.)
| | - Ibrahim M. Alanazi
- Department of Pharmacology and Toxicology, Faculty of Medicine, Umm Al-Qura University, Al-Abidiyah, P.O. Box 13578, Makkah 21955, Saudi Arabia; (A.R.A.); (S.S.A.-G.); (I.M.A.)
| | - Sidra Rehman
- Functional Genomics Laboratory, Department of Biosciences, COMSATS University Islamabad (CUI), Islamabad 45550, Pakistan;
| | - Sajida Hassan
- Viral Hepatitis Program, Laboratory of Medicine, University of Washington, Seattle, WA 98195, USA;
| |
Collapse
|
|
15
|
Chen B, Ma ZH, Xu B, Chang H, He XX, Pei LJ, Ren YN, Xing WG. Evaluation of seven rapid diagnostic tests for detection of hepatitis C virus antibodies in China. J Viral Hepat 2021; 28:657-663. [PMID: 33421262 DOI: 10.1111/jvh.13466] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/17/2020] [Accepted: 12/30/2020] [Indexed: 12/25/2022]
Abstract
Rapid diagnostic tests as an attractive alternative to enzyme immunoassay could identify hepatitis C virus (HCV) infected persons more expeditiously. The availability of high performing and quality-assured rapid diagnostic tests are essential to scale-up HCV screening. The study was undertaken to evaluate the performance of seven domestic HCV rapid diagnostic tests kits. The kits were evaluated by using HCV serum panels, including HCV basic panel, analytical specificity panel, mixed titre performance panel, characteristic panel, seroconversion panel, and genotype qualification panel. The results showed that clinical sensitivity, clinical specificity and analytical specificity of seven rapid diagnostic tests kits ranged from 94% (95% CI: 83.2-98.6) to 100% (95% CI: 91.5-100). Furthermore, specimens with HCV genotypes 1b, 2a, 3a, 4a, 5a, 6 could be detected by HCV rapid diagnostic tests kits, whereas specimens with genotypes 1a and 2b could not be detected. Additionally, most HCV rapid diagnostic tests kits had great performance in diagnosing different titres and/or different bands samples, but some low S/CO value specimens may not be fully detected by few rapid diagnostic test kits. In conclusion, seven HCV rapid diagnostic tests reagents presented high sensitivity, specificity, good anti-interference and detection ability of early infection, which could meet the requirements of clinical HCV antibody screening.
Collapse
Affiliation(s)
- Bing Chen
- National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.,Medical College, University of Chinese Academy of Sciences, Beijing, China
| | - Zhong-Hui Ma
- National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.,Fangshan District Center for Disease Control and Prevention in Beijing, China
| | - Bing Xu
- National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
| | - Hao Chang
- National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
| | - Xiao-Xia He
- Beijing Engineering Research Center of Food Safety Analysis, Beijing Engineering Technology Research Centre of Gene Sequencing and Gene Function Analysis, Beijing Center for Physical & Chemical Analysis, Beijing, China
| | - Li-Jian Pei
- National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
| | - Ya-Nan Ren
- National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
| | - Wen-Ge Xing
- National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
| |
Collapse
|
|
16
|
Prabdial‐Sing N, Gaelejwe L, Makhathini L, Thaver J, Manamela MJ, Malfeld S, Spearman CW, Sonderup M, Scheibe A, Young K, Hausler H, Puren AJ. The performance of hepatitis C virus (HCV) antibody point-of-care tests on oral fluid or whole blood and dried blood spot testing for HCV serology and viral load among individuals at higher risk for HCV in South Africa. Health Sci Rep 2021; 4:e229. [PMID: 33614978 PMCID: PMC7876859 DOI: 10.1002/hsr2.229] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/09/2020] [Revised: 11/10/2020] [Accepted: 12/04/2020] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND AND AIMS To enhance screening and diagnosis in those at-risk of hepatitis C virus (HCV), efficient and improved sampling and testing is required. We investigated the performance of point-of-care (POC) tests and dried blood spots (DBS) for HCV antibody and HCV RNA quantification in individuals at higher risk for HCV (people who use and inject drugs, sex workers and men who have sex with men) in seven South African cities. METHODS Samples were screened on the OraQuick HCV POC test (471 whole blood and 218 oral fluid); 218 whole blood and DBS paired samples were evaluated on the ARCHITECT HCV antibody (Abbott) and HCV viral load (COBAS Ampliprep/COBAS TaqMan version 2) assays. For HCV RNA quantification, 107 dB were analyzed with and without normalization coefficients. RESULTS POC on either whole blood or oral fluid showed an overall sensitivity of 98.5% (95% CI 97.4-99.5), specificity of 98.2% (95% CI 98.8-100) and accuracy of 98.4% (95% CI 96.5-99.3). On the antibody immunoassay, DBS showed a sensitivity of 96.0% (95% CI 93.4-98.6), specificity of 97% (95% CI 94.8-99.3) and accuracy of 96.3% (95% CI 93.8-98.8). A strong correlation (R 2 = 0.90) between viral load measurements for DBS and plasma samples was observed. After normalization, DBS viral load results showed an improved bias from 0.5 to 0.16 log10 IU/mL. CONCLUSION The POC test performed sufficiently well to be used for HCV screening in at-risk populations. DBS for diagnosis and quantification was accurate and should be considered as an alternative sample to test. POC and DBS can help scale up hepatitis services in the country, in light of our elimination goals.
Collapse
Affiliation(s)
- Nishi Prabdial‐Sing
- Centre for Vaccines and ImmunologyNational Institute for Communicable DiseasesJohannesburgSouth Africa
- Faculty of Health SciencesUniversity of WitwatersrandJohannesburgSouth Africa
| | - Lucinda Gaelejwe
- Centre for Vaccines and ImmunologyNational Institute for Communicable DiseasesJohannesburgSouth Africa
- Faculty of Health SciencesUniversity of WitwatersrandJohannesburgSouth Africa
| | - Lillian Makhathini
- Centre for Vaccines and ImmunologyNational Institute for Communicable DiseasesJohannesburgSouth Africa
| | - Jayendrie Thaver
- Centre for Vaccines and ImmunologyNational Institute for Communicable DiseasesJohannesburgSouth Africa
| | - Morubula Jack Manamela
- Centre for Vaccines and ImmunologyNational Institute for Communicable DiseasesJohannesburgSouth Africa
| | - Susan Malfeld
- Centre for Vaccines and ImmunologyNational Institute for Communicable DiseasesJohannesburgSouth Africa
| | - C. Wendy Spearman
- Division of Hepatology, Department of Medicine, Faculty of Health SciencesUniversity of Cape TownCape TownSouth Africa
| | - Mark Sonderup
- Division of Hepatology, Department of Medicine, Faculty of Health SciencesUniversity of Cape TownCape TownSouth Africa
| | - Andrew Scheibe
- TB HIV CareCape TownSouth Africa
- Department of Family MedicineUniversity of PretoriaPretoriaSouth Africa
| | | | | | - Adrian J. Puren
- Centre for Vaccines and ImmunologyNational Institute for Communicable DiseasesJohannesburgSouth Africa
- Faculty of Health SciencesUniversity of WitwatersrandJohannesburgSouth Africa
| |
Collapse
|
|
17
|
Narayanamurthy V, Jeroish ZE, Bhuvaneshwari KS, Samsuri F. Hepatitis C virus (HCV) diagnosis via microfluidics. ANALYTICAL METHODS : ADVANCING METHODS AND APPLICATIONS 2021; 13:740-763. [PMID: 33511975 DOI: 10.1039/d0ay02045a] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/12/2023]
Abstract
Humans are subjected to various diseases; hence, proper diagnosis helps avoid further disease consequences. One such severe issue that could cause significant damage to the human liver is the hepatitis C virus (HCV). Several techniques are available to detect HCV under various categories, such as detection through antibodies, antigens, and RNA. Although immunoassays play a significant role in discovering hepatitis viruses, there is a need for point-of-care tests (POCT). Some developing strategies are required to ensure the appropriate selection of POCT for HCV detection, initiate appropriate antiviral therapy, and define associated risks, which will be critical in achieving optimal outcomes. Though molecular assays are precise, reproducible, sensitive, and specific, alternative strategies are required to enhance HCV diagnosis among the infected population. Herein, we described and assessed the potential of various microfluidic detection techniques and confirmatory approaches used in present communities. In addition, current key market players in HCV chip-based diagnosis and the future perspectives on the basis of which the diagnosis can be made easier are presented in the present review.
Collapse
Affiliation(s)
- Vigneswaran Narayanamurthy
- Fakulti Teknologi Kejuruteraan Elektrik dan Elektronik, Universiti Teknikal Malaysia Melaka, Hang Tuah Jaya, 76100 Durian Tunggal, Melaka, Malaysia.
| | | | | | | |
Collapse
|
|
18
|
Rose CE, Duncan L, Hawes AM. Validation of OraQuick HCV Rapid Antibody Test in Postmortem Specimens. Acad Forensic Pathol 2020; 10:81-86. [PMID: 33282041 DOI: 10.1177/1925362120957521] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/13/2020] [Accepted: 07/16/2020] [Indexed: 11/15/2022]
Abstract
INTRODUCTION The objective of this study is to evaluate the performance of OraQuick HCV Rapid Antibody Test against a "gold-standard", FDA-approved, laboratory-based serum immunoassay (SI) in postmortem blood. To date, OraQuick HCV Rapid Antibody Test has not been evaluated for use in postmortem testing. This OraQuick test is a manually performed, visually interpreted, single use immunoassay for the qualitative detection of antibodies to the hepatitis C virus (HCV). METHODS Blood was collected from 51 decedents whose deaths were investigated in the jurisdiction of the Knox and Anderson County Medical Examiner's Office (MEO) January 2017 through April 2017. For each consented case, blood was tested using both the OraQuick HCV Rapid Antibody Test and a laboratory-based hepatitis C serum immunoassay ("gold standard" reference assay). Results from the OraQuick HCV Rapid Antibody Test were compared against a laboratory-based hepatitis C serum immunoassay. RESULTS Using the laboratory-based serum immunoassay (SI) as the "gold standard" for assessing true HCV antibody positivity, and comparing SI against OraQuick rapid test, sensitivity for the OraQuick rapid test was 95.65% and specificity was 96.15% in postmortem blood. DISCUSSION Our results demonstrate that OraQuick HCV rapid antibody test is reliable for diagnosis of hepatitis C infection in postmortem blood with a relatively short (less than approximately 21.5 hours) postmortem sample acquisition time. The OraQuick in some cases may be superior to traditional, laboratory-based HCV SI due to potential increased viscosity of postmortem blood.
Collapse
|
|
19
|
HEPCARE EUROPE- A case study of a service innovation project aiming at improving the elimination of HCV in vulnerable populations in four European cities. Int J Infect Dis 2020; 101:374-379. [PMID: 32992012 DOI: 10.1016/j.ijid.2020.09.1445] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/08/2020] [Revised: 09/18/2020] [Accepted: 09/22/2020] [Indexed: 12/11/2022] Open
Abstract
OBJECTIVES Hepatitis C Virus (HCV) is a significant cause of chronic liver disease. Among at-risk populations, access to diagnosis and treatment is challenging. We describe an integrated model of care, Hepcare Europe, developed to address this challenge. METHODS Using a case-study approach, we describe the cascade of care outcomes at all sites. Cost analyses estimated the cost per person screened and linked to care. RESULTS A total of 2608 participants were recruited across 218 clinical sites. HCV antibody test results were obtained for 2568(98•5%); 1074(41•8%) were antibody-positive, 687(60•5%) tested positive for HCV-RNA, 650(60•5%) were linked to care, and 319(43•5%) started treatment. 196(61•4%) of treatment initiates achieved a Sustained Viral Response (SVR) at dataset closure, 108(33•9%) were still on treatment, eight (2•7%) defaulted from treatment, and seven (2•6%) had virologic failure or died. The cost per person screened varied from €194 to €635, while the cost per person linked to care varied from €364 to €2035. CONCLUSIONS Hepcare enhanced access to HCV treatment and cure, and costs were affordable in all settings, offering a framework for scale-up and reproducibility.
Collapse
|
|
20
|
Houri I, Horowitz N, Katchman H, Weksler Y, Miller O, Deutsch L, Shibolet O. Emergency department targeted screening for hepatitis C does not improve linkage to care. World J Gastroenterol 2020; 26:4878-4888. [PMID: 32921964 PMCID: PMC7459203 DOI: 10.3748/wjg.v26.i32.4878] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/20/2020] [Revised: 06/13/2020] [Accepted: 08/09/2020] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Hepatitis C virus (HCV) infection is a leading cause of chronic liver disease worldwide. New treatments for HCV revolutionized management and prompted the world health organization to set the goal of viral elimination by 2030. These developments strengthen the need for HCV screening in order to identify asymptomatic carriers prior to development of chronic liver disease and its complications. Different screening strategies have been attempted, most targeting high-risk populations. Previous studies focusing on patients arriving at emergency departments showed a higher prevalence of HCV compared to the general population.
AIM To identify previously undiagnosed HCV carriers among high risk emergency room attendees and link them to care for anti-viral treatment.
METHODS In this single center prospective study, persons visiting the emergency department in an urban hospital were screened by a risk factor-specific questionnaire. The risk factors screened for were exposure to blood products or organ transplantation before 1992; origins from countries with high prevalence of HCV; intravenous drug use; human immunodeficiency virus carriers; men who have sex with men; those born to HCV-infected mothers; prior prison time; and chronic kidney disease. Those with at least one risk factor were tested for HCV by serum for HCV antibodies, a novel oral test from saliva (OraQuick®) or both.
RESULTS Five hundred and forty-one participants had at least one risk factor and were tested for HCV. Eighty four percent of all study participants had only one risk factor. Eighty five percent of participants underwent OraQuick® testing, 34% were tested for serum anti-HCV antibodies, and 25% had both tests. 3.1% of patients (17/541) had a positive result, compared to local population incidence of 1.96%. Of these, 82% were people who inject drugs (current or former), and 64% served time in prison. One patient had a negative HCV-RNA, and two patients died from non-HCV related reasons. On review of past medical records, 12 patients were found to have been previously diagnosed with HCV but were unaware of their carrier state. At 1-year follow-up none of the remaining 14 patients had completed HCV-RNA testing, visited a hepatology clinic or received anti-viral treatment.
CONCLUSION Targeted high-risk screening in the emergency department identified undiagnosed and untreated HCV carriers, but did not improve treatment rates. Other strategies need to be developed to improve linkage to care in high risk populations.
Collapse
Affiliation(s)
- Inbal Houri
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
| | - Noya Horowitz
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
| | - Helena Katchman
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
| | - Yael Weksler
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
| | - Ofer Miller
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
| | - Liat Deutsch
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
| | - Oren Shibolet
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
| |
Collapse
|
|
21
|
Jang MA, Kim B, Lee YK. Reporting Quality of Diagnostic Accuracy Studies in Laboratory Medicine: Adherence to Standards for Reporting of Diagnostic Accuracy Studies (STARD) 2015. Ann Lab Med 2020; 40:245-252. [PMID: 31858765 PMCID: PMC6933069 DOI: 10.3343/alm.2020.40.3.245] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/19/2019] [Revised: 08/23/2019] [Accepted: 11/22/2019] [Indexed: 12/21/2022] Open
Abstract
Background Poor reporting quality in diagnostic accuracy studies hampers an adequate judgment of the validity of the study. The Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement was published to improve the reporting quality of diagnostic accuracy studies. This study aimed to evaluate the adherence of diagnostic accuracy studies published in Annals of Laboratory Medicine (ALM) to STARD 2015 and to identify directions for improvement in the reporting quality of these studies. Methods Two independent authors assessed articles published in ALM between 2012–2018 for compliance with 30 STARD 2015 checklist items to identify all eligible diagnostic accuracy studies published during this period. We included 66 diagnostic accuracy studies. A total of the fulfilled STARD items were calculated, and adherence was analyzed on an individual-item basis. Results The overall mean±SD number of STARD items reported for the included studies was 11.2±2.7. Only five (7.6%) studies adhered to more than 50% of the 30 items. No study satisfied more than 80% of the items. Large variability in adherence to reporting standards was detected across items, ranging from 0% to 100%. Conclusions Adherence to STARD 2015 is suboptimal among diagnostic accuracy studies published in ALM. Our study emphasizes the necessity of adherence to STARD to improve the reporting quality of future diagnostic accuracy studies to be published in ALM.
Collapse
Affiliation(s)
- Mi Ae Jang
- Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea
| | - Bohyun Kim
- Department of Laboratory Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea
| | - You Kyoung Lee
- Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea.
| |
Collapse
|
|
22
|
Carvalho-Gomes Â, Cubells A, Pallarés C, Hontangas V, Conde I, Di Maira T, Peiró S, Sanfélix-Gimeno G, López-Labrador FX, Berenguer M. A population-based screening for hepatitis C antibodies and active infection using a point-of-care test in a low prevalence area. PLoS One 2020; 15:e0228351. [PMID: 32045417 PMCID: PMC7012430 DOI: 10.1371/journal.pone.0228351] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/27/2019] [Accepted: 01/13/2020] [Indexed: 12/14/2022] Open
Abstract
Background Data on the true prevalence of hepatitis C virus (HCV) infection in the general population is essential. We evaluated a program implementing free universal HCV screening using a non-invasive point-of-care test (POCT) (OraQuick-HCV rapid test) in oral fluid in an urban area in Valencia, South-Eastern Spain. Methods A cross-sectional study was performed during 2015–2017. Free HCV screening was offered by regular mail to 11,500 individuals aged 18 and over, randomly selected from all census residents in the Health Department. All responding participants filled in a questionnaire about HCV infection risk factors and were tested in their tertiary Hospital. In those with a positive POCT, results were confirmed by enzyme-immunoassay and HCV-RNA. Results 1,206 persons agreed to participate (response rate: 11.16%). HCV antibodies were detected in 19 (1.60%) cases (age-sex standardized rate: 1.31%; 95%CI: 0.82–2.07), but only 8 showed positive HCV-RNA (age-sex standardized rate: 0.56%; 95%CI: 0.28–1.14). The majority (89%) of the cases were born before 1965 and 74% had at least one known risk factor for HCV infection. All anti-HCV positive individuals were already aware of their infection, and no undiagnosed cases were detected. The performance of the POCT was excellent for detecting active infection. Conclusions These preliminary data suggest that HCV population screening with a POCT is feasible but, in our setting, mailing recruiting is not effective (11% response rate). The low prevalence of HCV antibodies and active infection in the participant population (with no new diagnoses made) suggests that, in our setting, underdiagnosis may be uncommon.
Collapse
Affiliation(s)
- Ângela Carvalho-Gomes
- Liver Transplantation and Hepatology Laboratory, Instituto de Investigación Sanitaria La Fe, València, Spain
- CIBERehd, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Madrid, Spain
| | - Almudena Cubells
- Liver Transplantation and Hepatology Laboratory, Instituto de Investigación Sanitaria La Fe, València, Spain
| | - Carmina Pallarés
- Liver Transplantation and Hepatology Laboratory, Instituto de Investigación Sanitaria La Fe, València, Spain
- CIBERehd, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Madrid, Spain
| | - Vanessa Hontangas
- Liver Transplantation and Hepatology Laboratory, Instituto de Investigación Sanitaria La Fe, València, Spain
| | - Isabel Conde
- Liver Transplantation and Hepatology Unit, Hospital Universitario y Politécnico La Fe, València, Spain
| | - Tomasso Di Maira
- Liver Transplantation and Hepatology Laboratory, Instituto de Investigación Sanitaria La Fe, València, Spain
| | - Salvador Peiró
- Health Services Research Area, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO Public Health), València, Spain
| | - Gabriel Sanfélix-Gimeno
- Health Services Research Area, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO Public Health), València, Spain
| | - F. Xavier López-Labrador
- Virology Laboratory, Joint Units in Genomics and Health and Infection and Health, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO Public Health) / Universitat de València, València, Spain
- CIBEResp, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública, Instituto de Salud Carlos III, Madrid, Spain
- * E-mail:
| | - Marina Berenguer
- Liver Transplantation and Hepatology Laboratory, Instituto de Investigación Sanitaria La Fe, València, Spain
- CIBERehd, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Madrid, Spain
- Liver Transplantation and Hepatology Unit, Hospital Universitario y Politécnico La Fe, València, Spain
- Department of Medicine, Universitat de València, València, Spain
| |
Collapse
|
|
23
|
Evaluation of a new point-of-care oral anti-HCV test for screening of hepatitis C virus infection. Virol J 2020; 17:14. [PMID: 32005264 PMCID: PMC6995050 DOI: 10.1186/s12985-020-1293-7] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/16/2019] [Accepted: 01/27/2020] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND Hepatitis C virus (HCV) infection is a public health issue for which an effective universal screening method is urgently needed. An oral anti-HCV test could provide a noninvasive and rapid screening strategy for HCV infection. This study evaluated the performance of a new point-of-care oral assay developed by Well for the detection of HCV antibody. METHODS Individuals from three centers with and without HCV infection were enrolled. All participants were tested for oral HCV antibody using the Well assay and for serum HCV antibody using established tests (ARCHITECT i2000 anti-HCV assay and InTec serum anti-HCV assay). For participants who obtained positive results, HCV RNA was tested for verification. Some patients underwent the OraQuick HCV test at the same time, and some self-tested with the Well assay during the same period. RESULTS A total of 1179 participants, including 486 patients with chronic HCV infection, 108 patients with other liver diseases, and 585 individuals who underwent physical examination, were enrolled. The Well anti-HCV test had a sensitivity of 91.88% (95% confidence interval [CI]: 88.97-94.09%) and a specificity of 98.00% (96.58-98.86%) for oral HCV antibody detection. The consistency between the Well and InTec assays was 97.02% (1138/1179). The consistency between the Well and OraQuick assays was 98.50% (197/200). Furthermore, the results of self-testing were highly consistent with those of researcher-administered tests (Kappa = 0.979). In addition, the HCV RNA results also showed that HCV RNA could only be detected on 1 of the 39 false-negative samples, and for 172 positive HCV RNA results, 171 could be detected by the Well oral anti-HCV assay. CONCLUSIONS The Well oral anti-HCV test offers high sensitivity and specificity and performed comparably to both the OraQuick assay and InTec assay for HCV diagnosis. Thus, the Well test represents a new tool for universal HCV screening to identify infected patients, particularly in regions with limited medical resources.
Collapse
|
|
24
|
Buchanan R, Meskarian R, van der Heijden P, Grellier L, Parkes J, Khakoo SI. Prioritising Hepatitis C treatment in people with multiple injecting partners maximises prevention: A real-world network study. J Infect 2019; 80:225-231. [PMID: 31887323 DOI: 10.1016/j.jinf.2019.12.010] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/10/2019] [Revised: 12/21/2019] [Accepted: 12/23/2019] [Indexed: 01/27/2023]
Abstract
OBJECTIVE To describe an injecting network of PWID living in an isolated community on the Isle of Wight (UK) and the results of a agent-based simulation, testing the effect of Hepatitis C (HCV) treatment on transmission. METHOD People who inject drugs (PWID) were identified via respondent driven sampling and recruited to a network and bio-behavioural survey. The injecting network they described formed the baseline population and potential transmission pathways in an agent-based simulation of HCV transmission and the effects of treatment over 12 months. RESULTS On average each PWID had 2.6 injecting partners (range 0-14) and 137 were connected into a single component. HCV in the network was associated with a higher proportion of positive injecting partners (p = 0.003) and increasing age (p = 0.011). The treatment of well-connected PWID led to significantly fewer new infections of HCV than treating at random (10 vs. 7, p<0.001). In all scenarios less than one individual was re-infected. CONCLUSION In our model the preferential treatment of well-connected PWID maximised treatment as prevention. In the real-world setting, targeting treatment to actively injecting PWID, with multiple injecting partners may therefore represent the most efficient elimination strategy for HCV.
Collapse
Affiliation(s)
- Ryan Buchanan
- Department of Population Science and Medical Statistics, Faculty of Medicine, C level, South Academic block, University of Southampton, Southampton, NH, United Kingdom.
| | - Rudabeh Meskarian
- Department of Mathematics, University of Southampton, Southampton, United Kingdom.
| | - Peter van der Heijden
- Southampton Statistical Science Research, University of Southampton, Southampton, and Methodology & Statistics Department, Utrecht University, United Kingdom.
| | - Leonie Grellier
- Department of Gastroenterology, St Mary's Hospital, Isle of Wight, United Kingdom.
| | - Julie Parkes
- Department of Population Science and Medical Statistics, Faculty of Medicine, C level, South Academic block, University of Southampton, Southampton, NH, United Kingdom.
| | - Salim I Khakoo
- Clinical and Experimental Sciences, Faculty of Medicine, E level, South Academic block, University of Southampton, Southampton, Hampshire, United Kingdom.
| |
Collapse
|
|
25
|
Setyowati D, Mubawadi T, Mirasa YA, Purwanto D, Amin M, Utsumi T, Soetjipto S, Juniastuti J, Lusida MI. Molecular epidemiology of hepatitis A outbreaks in two districts in Indonesia in 2018: Same subtype, but different strains. Biomed Rep 2019; 12:51-58. [PMID: 31929874 PMCID: PMC6951258 DOI: 10.3892/br.2019.1261] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/10/2019] [Accepted: 10/18/2019] [Indexed: 12/26/2022] Open
Abstract
The present study aimed to analyse molecular epidemiological data from hepatitis A virus (HAV) outbreaks in two affected areas. The association between the knowledge of hepatitis A and incidence of infection was also determined. Serum samples were obtained from 88 individuals with clinical manifestations of acute hepatitis in Lamongan (n=54) in January 2018 and Bangkalan (n=34) in March 2018. The outbreak investigation was started one day after the outbreaks were reported by the Public Health Offices in Lamongan and Bangkalan. Anti-HAV immunoglobulin M (IgM) and PCR amplification products of the VP1 capsid protein-P2A protease and VP1-VP3 junctions were analysed. Positive PCR products were sequenced, and a phylogenetic tree was constructed using Molecular Evolutionary Genetics Analysis X software. The control group comprised healthy students and staff members from the two affected areas. Thus, 172 responses from the control and hepatitis A case groups were analysed to assess the association between the students' knowledge level and the incidence of HAV infection. A total of 32 (59.25%) of the 54 individuals from Lamongan and 19 (55.9%) of the 34 participants from Bangkalan were positive for anti-HAV IgM; 26 PCR tests were positive in the VP3-VP1 and/or VP1-P2A junction, which were identified as HAV subgenotype IA. The subtype of HAV in the two areas was IA, similar to those identified previously, but the viruses did not originate from the same strain, as identified by multiple alignment. The knowledge level of the students and staff members in Lamongan studying and working at a half-day school exhibited a significant association with the incidence; however, no association was observed among the students in Bangkalan studying at a full-day school with a dormitory.
Collapse
Affiliation(s)
- Dewi Setyowati
- Faculty of Medicine, Airlangga University, Surabaya, East Java 60131, Indonesia
| | - Teguh Mubawadi
- Regional Center for Environmental Health and Disease Control of Surabaya, Surabaya, East Java 60175, Indonesia
| | - Yudied Agung Mirasa
- Regional Center for Environmental Health and Disease Control of Surabaya, Surabaya, East Java 60175, Indonesia
| | - Didik Purwanto
- Regional Center for Environmental Health and Disease Control of Surabaya, Surabaya, East Java 60175, Indonesia
| | - Mochamad Amin
- Institute of Tropical Disease, Airlangga University, Surabaya, East Java 60115, Indonesia
| | - Takako Utsumi
- Institute of Tropical Disease, Airlangga University, Surabaya, East Java 60115, Indonesia.,Center for Infectious Diseases, Kobe University Graduate School of Medicine, Kobe, Hyogo 650-0017, Japan
| | - Soetjipto Soetjipto
- Faculty of Medicine, Airlangga University, Surabaya, East Java 60131, Indonesia.,Institute of Tropical Disease, Airlangga University, Surabaya, East Java 60115, Indonesia
| | - Juniastuti Juniastuti
- Faculty of Medicine, Airlangga University, Surabaya, East Java 60131, Indonesia.,Institute of Tropical Disease, Airlangga University, Surabaya, East Java 60115, Indonesia
| | - Maria Inge Lusida
- Faculty of Medicine, Airlangga University, Surabaya, East Java 60131, Indonesia.,Institute of Tropical Disease, Airlangga University, Surabaya, East Java 60115, Indonesia
| |
Collapse
|
|
26
|
Chionne P, Madonna E, Villano U, Tritarelli E, Pisani G, Costantino A, Equestre M, Marcantonio C, Bruni R, Ciccaglione AR. Sensitivity of hepatitis C virus rapid tests in detecting antibodies in general population. Panminerva Med 2019; 62:125-130. [PMID: 31692308 DOI: 10.23736/s0031-0808.19.03678-4] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
BACKGROUND Evaluation of clinical performance of the anti-hepatitis C virus (HCV) rapid tests were carried out mostly in chronic hepatitis C patients and in individuals at high risk of HCV infection. METHODS The aim of this study was to evaluate the performance of OraQuick and Wantai rapid tests on archived serum samples from 1408 individuals (mean age 46, range 18-90; 65% female) recruited with a systematic sampling procedure during a general population survey. RESULTS The analysis of samples by Ortho HCV 3.0 ELISA and Cobas Taqman HCV RNA assays resulted in 69 anti-HCV antibody positive sera, including 42 HCV RNA positive (group 1) and 27 HCV RNA negative (group 2) samples. The performance of rapid tests was evaluated on the 69 anti-HCV positive (group 1+2) and 206 (OraQuick) and 198 (Wantai) anti-HCV negative sera, randomly selected from the 1339 anti-HCV negative samples. The OraQuick and Wantai rapid assays showed a sensitivity in group 1 of 92.9% and 90.5%, respectively. The sensitivity in group 2 was 40.7% and 51.9%, respectively. The anti-HCV antibodies signal/cutoff mean value was the only parameter that statistically differed between group 1 and group 2 individuals (P<0.0001). Further, 3 (OraQuick) and 4 samples (Wantai) from group 1, with very low HCV RNA level (<25 UI/mL), were misdiagnosed by rapid assays as false negative. CONCLUSIONS The proportion of infections with low level of viremia and the risk associated with rapid assay failure remained to be carefully estimated in general population.
Collapse
Affiliation(s)
- Paola Chionne
- Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy
| | - Elisabetta Madonna
- Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy
| | - Umbertina Villano
- Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy
| | - Elena Tritarelli
- Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy
| | - Giulio Pisani
- Center for Immunobiologicals Research and Evaluation, Istituto Superiore di Sanità, Rome, Italy
| | - Angela Costantino
- Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy
| | - Michele Equestre
- Department of Cell Biology and Neurosciences, Istituto Superiore di Sanità, Rome, Italy
| | - Cinzia Marcantonio
- Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy
| | - Roberto Bruni
- Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy
| | - Anna R Ciccaglione
- Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy -
| |
Collapse
|
|
27
|
Developments in the HCV Screening Technologies Based on the Detection of Antigens and Antibodies. SENSORS 2019; 19:s19194257. [PMID: 31575036 PMCID: PMC6806196 DOI: 10.3390/s19194257] [Citation(s) in RCA: 19] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 08/14/2019] [Revised: 09/20/2019] [Accepted: 09/27/2019] [Indexed: 02/06/2023]
Abstract
Hepatitis C virus (HCV) accounts for 15%-20% of cases of acute infection, and chronic HCV infection is developed in about 50%-80% of HCV patients. Unfortunately, due to the lack of proper medical care, difficulty in screening for HCV infection, and lack of awareness resulted in chronic HCV infection in 71 million people on a global scale, and about 399,000 deaths in 2016. It is crucial to recognize that the effective use of antiviral medicines can cure more than 95% of HCV infected people. The Global Health Sector Strategy (GHSS) aim is to reduce the new HCV infections and the HCV associated mortality by 90% and 65%, respectively. Therefore, the methods that are simple, yet powerful enough to detect HCV infections with high sensitivity, specificity, and a shorter window period are crucial to restrain the global burden of HCV healthcare. This article focuses on the technologies used for the detection of HCV in clinical specimens.
Collapse
|
|
28
|
Orrego-Marín CM, Bedoya AM, Cardona Arias JA. Metaanálisis de la validez y el desempeño de las pruebas de tamización del virus de la hepatitis C en bancos de sangre, 2000-2018. ACTA BIOLÓGICA COLOMBIANA 2019. [DOI: 10.15446/abc.v24n3.79348] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/09/2022] Open
Abstract
Este estudio evaluó la validez y desempeño del inmunodiagnóstico del virus de la hepatitis C (VHC), con base en estudios publicados en la literatura científica mundial. Se diseñó y validó un protocolo de búsqueda y selección de investigaciones en las fases de la guía PRISMA, se analizaron los parámetros de sensibilidad, especificidad, cocientes de probabilidad, razón de odds y curva ROC, en MetaDisc. Se tamizaron 4602 estudios, de los cuales sólo 545 se realizaron en bancos de sangre y 18 evaluaron la validez diagnóstica de las pruebas para el VHC. La mayoría de los estudios fueron de Europa y Asia, con un 78 % basados en determinación de anticuerpos. Los estudios con detección de anticuerpos se realizaron en 21 483 donantes sanos y 3 145 infectados en quienes se halló una sensibilidad de 97,8 % (IC 95 % = 97,3 - 98,2), especificidad 99,0 % (IC 95 % = 98,9 - 99,2), cociente de probabilidad positivo 75,4 (IC 95 % = 27,2 - 209,2) y negativo de 0,02 (IC 95 % = 0,01 - 0,07) y área bajo la curva de 99,8 %. Se concluye que la detección de anticuerpos presenta excelente validez, desempeño y utilidad diagnóstica para la detección del VHC en donantes de sangre y población general.
Collapse
|
|
29
|
Mahajan S, Agarwal R, Rawat V, Kumar G, Sharma MK, Gupta E. Comparative evaluation of three rapid immunochromatographic test assays with chemiluminescent microparticle immunoassay for the detection of hepatitis C virus antibody. Virusdisease 2019; 30:373-379. [PMID: 31803804 DOI: 10.1007/s13337-019-00542-5] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/11/2019] [Accepted: 07/08/2019] [Indexed: 12/17/2022] Open
Abstract
Rapid diagnostic tests (RDTs) can serve as good alternatives to standard serological assays for hepatitis C virus (HCV) detection in limited resource settings. Aim of this study was to evaluate performance of three Indian manufactured RDTs with chemiluminescent microparticle immunoassay (CLIA) for screening of HCV infection with further evaluation using HCV RNA. Serum samples tested for anti-HCV by CLIA (Architect i1000SR, Abbott Diagnostics, IL, USA) were retrieved from - 80 °C and retested for anti-HCV by three RDTs: Alere Trueline (SD Bioline; Haryana, India) (RDT 1), Benesphera HCV Rapid card test (Avantor Performance Materials India Limited; Uttarakhand, India) (RDT 2), AccuTest HCV (Accurex Biomedical Pvt. Ltd.; Mumbai, India) (RDT 3). HCV RNA results were obtained from hospital information system and anti-HCV reactive but RNA negative cases without treatment were considered as either 'false positives' or 'spontaneous clearance of HCV RNA'. Among 86 samples, 75 (87.2%), 49 (57%), 58 (67.4%) and 51 (59.3%) were reactive by CLIA, RDT1, RDT2 and RDT3, respectively. Taking CLIA as reference standard, RDT 1, 2 and 3 demonstrated sensitivity of 65.30%, 77.33% and 68% respectively. Specificity of all three RDTs was 100% with sensitivity of 97.6-100% above signal/cut-off ratio (S/Co) of 6 by CLIA and 88-100% in all HCV RNA positive cases. Sensitivity of RDTs increased from 65.30-77.33 to 72-82.4% when RNA negative/anti-HCV reactive results were considered as non-reactive. The three RDTs have acceptable sensitivity and specificity in anti-HCV detection especially in RNA positive patients that would require treatment for HCV.
Collapse
Affiliation(s)
- Supriya Mahajan
- 1Department of Clinical Virology, Institute of Liver and Biliary Sciences, New Delhi, India
| | - Reshu Agarwal
- 1Department of Clinical Virology, Institute of Liver and Biliary Sciences, New Delhi, India
| | - Vaishali Rawat
- 1Department of Clinical Virology, Institute of Liver and Biliary Sciences, New Delhi, India
| | - Guresh Kumar
- 2Department of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, India
| | - Manoj Kumar Sharma
- 3Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India
| | - Ekta Gupta
- 1Department of Clinical Virology, Institute of Liver and Biliary Sciences, New Delhi, India
| |
Collapse
|
|
30
|
Yang RF, Liu Y, Zhao CY, Ding YX, Chen Y, Wang YD, Duan ZP. A novel point-of-care oral anti-HCV assay: Is it reliable for screening hepatitis C virus infection in the era of direct-acting antivirals? PLoS One 2019; 14:e0211795. [PMID: 30753207 PMCID: PMC6372169 DOI: 10.1371/journal.pone.0211795] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/31/2018] [Accepted: 01/21/2019] [Indexed: 02/08/2023] Open
Abstract
Recent advance in the direct-acting antivirals (DAAs) offers the potentials to eradicate hepatitis C virus (HCV) worldwide and makes universal screening more urgent. A point-of-care (POC) oral anti-HCV assay, the Fortune assay, was developed and its performance was evaluated. Individuals with or without HCV infection were recruited in three Centers. Paired oral and serum samples were tested using the Fortune and InTec anti-HCV assays. The Kehua serum anti-HCV assay served as a supplemental test to verify the discordant results. Some oral samples were also tested using the OraQuick anti-HCV assay. Furthermore, the Fortune assay results were compared with the documented RNA results. Sensitivity, specificity, and accuracy of the Fortune assay was 93.11%, 98.48%, and 96.58%, respectively (n = 1,022). Consistency between the Fortune and OraQuick assays was 96.35% (264/274); the Fortune assay detected additional 8 positive oral samples missed by the OraQuick assay. The Fortune assay demonstrated a 97.46% (115/118) positivity among the viremic patients. Furthermore, its sensitivity was HCV genotype independent. In conclusion, the Fortune assay was highly specific and accurate. It had comparable sensitivity as the serum assays for the diagnosis of active HCV infection. It provides a completely non-invasive and reliable tool for HCV screening in the DAA era.
Collapse
Affiliation(s)
- Rui-Feng Yang
- Peking University People’s Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing, China
| | - Yan Liu
- Peking University People’s Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing, China
| | - Cai-Yan Zhao
- Infectious Diseases Department, the Third Hospital of Hebei Medical University, Shijiazhuang, China
| | - Ya-Xing Ding
- Tianjin Center for Diseases Control and Prevention, Tianjin, China
| | - Yu Chen
- Artificial Liver Center, Beijing You’an Hospital, Capital Medical University, Beijing, China
| | - Ya-Dong Wang
- Infectious Diseases Department, the Third Hospital of Hebei Medical University, Shijiazhuang, China
| | - Zhong-Ping Duan
- Artificial Liver Center, Beijing You’an Hospital, Capital Medical University, Beijing, China
| |
Collapse
|
|
31
|
de Almeida Ribeiro CR, Amado LA, Tourinho RS, Pinto Lima LR, Melgaço JG, de Almeida AJ, Bastos LS, Lewis-Ximenez LL, de Paula VS. Accuracy of rapid test for diagnosis of hepatitis A with different infection rate settings and with predictive modeling. Future Microbiol 2019; 14:247-258. [PMID: 30663895 DOI: 10.2217/fmb-2018-0211] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/28/2022] Open
Abstract
AIM We evaluated the accuracy of a commercial rapid immunochromatographic test (rapid test [RT]) for hepatitis A (HA) diagnosis and epidemiological studies. MATERIALS & METHODS The accuracy of a RT was evaluated in laboratory and in field conditions. Predictive modeling estimated the test performance in a hypothetical population. RESULTS The RT showed sensitivities of 66-86%, and specificities of 21-100%, depending on the antibody isotype (IgM or IgG) analyzed and prevalence of infection. CONCLUSION The RT is a good alternative for diagnostic in HA outbreaks. The predictive model indicates that it should not be used alone for HA diagnosis in low prevalence populations. These data can be used in the future to strengthen decision-making during the implementation of rapid diagnostic methods in health services.
Collapse
Affiliation(s)
| | - Luciane A Amado
- Laboratory of Development Technological in Virology, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil
| | - Renata S Tourinho
- Laboratory of Development Technological in Virology, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil
| | - Lyana R Pinto Lima
- Laboratory of Molecular Virology, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil
| | - Juliana G Melgaço
- Laboratory of Development Technological in Virology, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil
| | - Adilson J de Almeida
- Department of General Medicine, Gaffrée & Guinle University Hospital, Federal University of the State of Rio de Janeiro School of Medicine & Surgery, Rio de Janeiro, Brazil
| | - Leonardo S Bastos
- Scientific Computing Program, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil
| | - Lia L Lewis-Ximenez
- Ambulatory Clinic of Viral Hepatitis/Viral Hepatitis Laboratory, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil
| | - Vanessa S de Paula
- Laboratory of Molecular Virology, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil
| |
Collapse
|
|
32
|
Alimohammadi A, Holeksa J, Parsons R, Yung R, Amiri N, Truong D, Conway B. Diagnosis and treatment of hepatitis C virus infection: a tool for engagement with people who inject drugs in Vancouver's Downtown Eastside. CANADIAN LIVER JOURNAL 2018; 1:14-33. [PMID: 35990714 PMCID: PMC9202795 DOI: 10.3138/canlivj.1.2.002] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/12/2018] [Accepted: 03/12/2018] [Indexed: 05/17/2025]
Abstract
BACKGROUND Vancouver's Downtown Eastside (DTES) faces the interrelated challenges of poverty, homelessness, mental health, addiction, and medical issues such as hepatitis C virus (HCV). This study evaluates a new model of engagement with people who inject drugs (PWID) in the DTES. METHODS Our centre has developed the community pop-up clinic (CPC) to engage vulnerable populations such as PWID. Rapid HCV testing is offered using the OraQuick saliva assay. If a test is positive, immediate medical consultation and an incentivized clinic appointment are offered. At this appointment, an HCV treatment plan is developed, along with a plan for engagement in multidisciplinary care. RESULTS In 12 months, 1,283 OraQuick tests were performed at 44 CPCs; 21% of individuals were found to be positive for HCV (68% of whom were PWID). Of individuals positive for HCV antibodies who consulted with the on-site doctor, 50% engaged in care in our clinic-61% of whom have initiated interferon-free directly acting antiviral (DAA) HCV therapy with 100% cured of HCV (per protocol). Individuals who did not engage in care were significantly more likely to be homeless (P < .0001). CONCLUSION CPCs paired with a multidisciplinary model of care address the needs of vulnerable populations such as PWID, particularly in the management of HCV with interferon-free DAA therapies.
Collapse
Affiliation(s)
- Arshia Alimohammadi
- Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada
- These authors contributed equally to the article
| | - Julie Holeksa
- Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada
- These authors contributed equally to the article
| | - Robyn Parsons
- Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada
| | - Rossita Yung
- Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada
| | - Neilofar Amiri
- Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada
| | - David Truong
- Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada
| | - Brian Conway
- Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada
| |
Collapse
|
|
33
|
Saab S, Le L, Saggi S, Sundaram V, Tong MJ. Toward the elimination of hepatitis C in the United States. Hepatology 2018; 67:2449-2459. [PMID: 29181853 DOI: 10.1002/hep.29685] [Citation(s) in RCA: 34] [Impact Index Per Article: 4.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/22/2017] [Revised: 11/13/2017] [Accepted: 11/20/2017] [Indexed: 12/12/2022]
Abstract
The emergence of effective direct-acting antiviral (DAA) agents has reignited discussion over the potential for hepatitis C elimination in the United States. Eliminating hepatitis C will require a critical examination of technical feasibility, economic considerations, and social/political attention. Tremendous advancement has been made with the availability of sensitive diagnostic tests and highly effective DAAs capable of achieving sustained viral response (SVR) in more than 95% of patients. Eliminating hepatitis C also requires escalating existing surveillance networks to monitor for new epidemics. All preventive interventions such as clean syringe and needle exchange programs, safe injection sites, opioid substitution therapies, and mental health services need to be expanded. Although costs of DAAs have raised budget concerns for hepatitis C elimination, studies have shown that eliminating hepatitis C will produce a savings of up to 6.5 billion USD annually along with other intangible benefits such as increased work productivity and quality of life. Economic models and meta-analyses strongly suggest universal hepatitis C screening for all adults rather than just for birth cohort and high-risk populations. Social and political factors are at least as important as technical feasibility and economic considerations. Due to lack of promotion and public awareness, HCV elimination efforts continue to receive inadequate funding. Social stigma continues to impede meaningful policy changes. Eliminating hepatitis C is an attainable public health goal that will require intense collaboration and sustained public support. (Hepatology 2018;67:2449-2459).
Collapse
Affiliation(s)
- Sammy Saab
- Department of Surgery, University of California Los Angeles, Los Angeles, CA
| | - Long Le
- Department of Medicine, University of California Los Angeles, Los Angeles, CA
| | - Satvir Saggi
- Olive View Medical Center, University of California Los Angeles, Los Angeles, CA
| | - Vinay Sundaram
- Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA
| | | |
Collapse
|
|
34
|
Swan D, Cullen W, Macias J, Oprea C, Story A, Surey J, Vickerman P, Lambert JS. Hepcare Europe - bridging the gap in the treatment of hepatitis C: study protocol. Expert Rev Gastroenterol Hepatol 2018; 12:303-314. [PMID: 29300496 DOI: 10.1080/17474124.2018.1424541] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/02/2023]
Abstract
BACKGROUND Hepatitis C (HCV) infection is highly prevalent among people who inject drugs (PWID). Many PWID are unaware of their infection and few have received HCV treatment. Recent developments in treatment offer cure rates >90%. However, the potential of these treatments will only be realised if HCV identification among PWID with linkage to treatment is optimised. This paper describes the Hepcare Europe project, a collaboration between five institutions across four member states (Ireland, UK, Spain, Romania), to develop, implement and evaluate interventions to improve the identification, evaluation and treatment of HCV among PWID. METHODS A service innovation project and a mixed-methods, pre-post intervention study, Hepcare will design and deliver interventions in Dublin, London, Seville and Bucharest to enhance PWID engagement and retention in the cascade of HCV care. RESULTS The feasibility, acceptability, potential efficacy and cost-effectiveness of these interventions to improve care processes and outcomes among PWID will be evaluated. CONCLUSION Hepcare has the potential to make an important impact on patient care for marginalised populations who might otherwise go undiagnosed and untreated. Lessons learned from the study can be incorporated into national and European guidelines and strategies for HCV.
Collapse
Affiliation(s)
- Davina Swan
- a UCD School of Medicine , University College Dublin , Dublin , Ireland
| | - Walter Cullen
- a UCD School of Medicine , University College Dublin , Dublin , Ireland
| | - Juan Macias
- b Unidad de Enfermedades Infecciosas y Microbiología , Hospital Universitario de Valme , Seville , Spain
| | - Cristiana Oprea
- c Infectious Diseases Department , Victor Babes Clinical Hospital for Infectious and Tropical Diseases , Bucharest , Romania.,d Infectious Diseases Department , Carol Davila University of Medicine and Pharmacy , Bucharest , Romania
| | - Alistair Story
- e Find & Treat Service , University College London Hospitals NHS Foundation Trust , London , UK
| | - Julian Surey
- f Institute of Global Health , University College London , London , UK
| | - Peter Vickerman
- g School of Social and Community Medicine, Oakfield House , University of Bristol , Bristol , UK
| | - John S Lambert
- a UCD School of Medicine , University College Dublin , Dublin , Ireland.,h Centre for Research in Infectious Diseases , Mater Misericordiae University Hospital , Dublin , Ireland
| |
Collapse
|
|
35
|
Isho NY, Kachlic MD, Marcelo JC, Martin MT. Pharmacist-initiated hepatitis C virus screening in a community pharmacy to increase awareness and link to care at the medical center. J Am Pharm Assoc (2003) 2018; 57:S259-S264. [PMID: 28506379 DOI: 10.1016/j.japh.2017.03.006] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/29/2016] [Revised: 03/10/2017] [Accepted: 03/13/2017] [Indexed: 02/07/2023]
Abstract
OBJECTIVE To describe the design and implementation of a pharmacist-led hepatitis C virus (HCV) screening and education program in a community pharmacy with a protocol for linkage to care at the affiliated hepatology clinic for patients born between 1945 and 1965. SETTING Outpatient pharmacy affiliated with the University of Illinois Hospital and Health Sciences System. PRACTICE DESCRIPTION The community pharmacist resident conducted the HCV screening at the health system-based community pharmacy. PRACTICE INNOVATION Community pharmacists provided patients with HCV screening and education while patients waited for their prescriptions to be ready or upon appointment. Patients were given a questionnaire before and after HCV education to assess the impact of pharmacist-provided education on patient knowledge. A protocol was developed to link patients with a positive HCV antibody test result to care with a hepatologist for confirmatory testing at a follow-up appointment at the medical center. EVALUATION Investigators assessed the feasibility of providing the screening and education, recorded the number of patients screened, and recorded the differences in the questionnaire responses before and after education. RESULTS Pharmacist-led HCV screening services were implemented successfully at the community pharmacy. All patients had a negative antibody result; therefore, linkage to care at the medical center, although available, was not necessary. The self-reported posttest HCV knowledge scores were significantly higher than pretest scores. CONCLUSION This article outlines the methodology for providing a multidisciplinary HCV screening, education, and referral program in a community pharmacy affiliated with a medical center. Pharmacist-initiated HCV screening in a community pharmacy can assist with identifying patients at risk for HCV infection and provide patients with linkage to care in the health system. This report may encourage community pharmacists to conduct future prospective trials to evaluate clinical and economic outcomes of community-based HCV screenings.
Collapse
|
|
36
|
Abstract
BACKGROUND Hepatitis C virus (HCV) is a global medical health concern. Egypt has the highest HCV prevalence. Few studies have assessed the HCV prevalence rates among Egyptian-born expatriates. We sought to define the HCV prevalence Egyptian-born individuals residing in the Southern California area. PATIENTS AND METHODS We screened Egyptian-born individuals in houses of worship in the Southern California area using a point of care test HCV antibody test. Results were confirmed by testing the blood for viral load. Demographic information including risk factors were also collected. Individuals were contacted with their results, and those found to be detectable HCV antibodies were referred for further testing and additional care. RESULTS Three hundred twenty-six Egyptian expatriates from 7 houses of worship in Southern California were screened for the HCV infection. Most of the participants were screened at Coptic Churches. Nine of these individuals were found to be HCV infected (2.8%). We found an increased HCV seroprevalence in subjects were male and born in Egyptian urban areas. Five of the 9 subjects (56%) who tested positive were not baby boomers and only 2 of these 9 subjects (22%) had recognized Center for Disease Control risk factors. CONCLUSIONS The HCV prevalence rate of Egyptian-born individuals living in the Southern California area was lower compared with the prevalence rate in the general Egyptian population, but higher than that seen in the general US population. The utility of using Center for Disease Control risk factors to define individuals at risk of HCV among Egyptian expatriates is not applicable.
Collapse
|
|
37
|
Sonderup MW, Afihene M, Ally R, Apica B, Awuku Y, Cunha L, Dusheiko G, Gogela N, Lohouès-Kouacou MJ, Lam P, Lesi O, Mbaye PS, Musabeyezu E, Musau B, Ojo O, Rwegasha J, Scholz B, Shewaye AB, Tzeuton C, Kassianides C, Spearman CW. Hepatitis C in sub-Saharan Africa: the current status and recommendations for achieving elimination by 2030. Lancet Gastroenterol Hepatol 2017; 2:910-919. [DOI: 10.1016/s2468-1253(17)30249-2] [Citation(s) in RCA: 50] [Impact Index Per Article: 6.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/08/2017] [Revised: 07/18/2017] [Accepted: 07/27/2017] [Indexed: 12/16/2022]
|
|
38
|
Tang W, Chen W, Amini A, Boeras D, Falconer J, Kelly H, Peeling R, Varsaneux O, Tucker JD, Easterbrook P. Diagnostic accuracy of tests to detect Hepatitis C antibody: a meta-analysis and review of the literature. BMC Infect Dis 2017; 17:695. [PMID: 29143615 PMCID: PMC5688422 DOI: 10.1186/s12879-017-2773-2] [Citation(s) in RCA: 85] [Impact Index Per Article: 10.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/29/2022] Open
Abstract
BACKGROUND Although direct-acting antivirals can achieve sustained virological response rates greater than 90% in Hepatitis C Virus (HCV) infected persons, at present the majority of HCV-infected individuals remain undiagnosed and therefore untreated. While there are a wide range of HCV serological tests available, there is a lack of formal assessment of their diagnostic performance. We undertook a systematic review and meta-analysis to evaluate he diagnostic accuracy of available rapid diagnostic tests (RDT) and laboratory based EIA assays in detecting antibodies to HCV. METHODS We used the PRISMA checklist and Cochrane guidance to develop our search protocol. The search strategy was registered in PROSPERO (CRD42015023567). The search focused on hepatitis C, diagnostic tests, and diagnostic accuracy within eight databases (MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, Science Citation Index Expanded, Conference Proceedings Citation Index-Science, SCOPUS, Literatura Latino-Americana e do Caribe em Ciências da Saúde and WHO Global Index Medicus. Studies were included if they evaluated an assay to determine the sensitivity and specificity of HCV antibody (HCV Ab) in humans. Two reviewers independently extracted data and performed a quality assessment of the studies using the QUADAS tool. We pooled test estimates using the DerSimonian-Laird method, by using the software R and RevMan. 5.3. RESULTS A total of 52 studies were identified that included 52,673 unique test measurements. Based on five studies, the pooled sensitivity and specificity of HCV Ab rapid diagnostic tests (RDTs) were 98% (95% CI 98-100%) and 100% (95% CI 100-100%) compared to an enzyme immunoassay (EIA) reference standard. High HCV Ab RDTs sensitivity and specificity were observed across screening populations (general population, high risk populations, and hospital patients) using different reference standards (EIA, nucleic acid testing, immunoblot). There were insufficient studies to undertake subanalyses based on HIV co-infection. Oral HCV Ab RDTs also had excellent sensitivity and specificity compared to blood reference tests, respectively at 94% (95% CI 93-96%) and 100% (95% CI 100-100%). Among studies that assessed individual oral RDTs, the eight studies revealed that OraQuick ADVANCE® had a slightly higher sensitivity (98%, 95% CI 97-98%) compared to the other oral brands (pooled sensitivity: 88%, 95% CI 84-92%). CONCLUSIONS RDTs, including oral tests, have excellent sensitivity and specificity compared to laboratory-based methods for HCV antibody detection across a wide range of settings. Oral HCV Ab RDTs had good sensitivity and specificity compared to blood reference standards.
Collapse
Affiliation(s)
- Weiming Tang
- University of North Carolina Project-China, No. 2 Lujing Road, Guangzhou, 510095 China
- Guangdong Provincial Dermatology Hospital (Dermatology Hospital, Southern Medical University), Guangzhou, China
- SESH Global, Guangzhou, China
- School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC USA
| | - Wen Chen
- School of Public Health, Sun Yat-sen University, Guangzhou, China
- Center for Migrant Health Policy, Sun Yat-sen University, Guangzhou, China
| | - Ali Amini
- London School of Hygiene and Tropical Medicine, Keppel St, London, UK
| | - Debi Boeras
- London School of Hygiene and Tropical Medicine, Keppel St, London, UK
| | - Jane Falconer
- London School of Hygiene and Tropical Medicine, Keppel St, London, UK
| | - Helen Kelly
- London School of Hygiene and Tropical Medicine, Keppel St, London, UK
| | - Rosanna Peeling
- London School of Hygiene and Tropical Medicine, Keppel St, London, UK
| | - Olivia Varsaneux
- London School of Hygiene and Tropical Medicine, Keppel St, London, UK
| | - Joseph D. Tucker
- University of North Carolina Project-China, No. 2 Lujing Road, Guangzhou, 510095 China
- SESH Global, Guangzhou, China
- School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC USA
- London School of Hygiene and Tropical Medicine, Keppel St, London, UK
| | - Philippa Easterbrook
- Global Hepatitis Programme, HIV Department, World Health Organization, Geneva, Switzerland
| |
Collapse
|
|
39
|
Kalichman SC, Hernandez D, Finneran S, Price D, Driver R. Transgender women and HIV-related health disparities: falling off the HIV treatment cascade. Sex Health 2017; 14:469-476. [PMID: 28870282 DOI: 10.1071/sh17015] [Citation(s) in RCA: 66] [Impact Index Per Article: 8.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/28/2017] [Accepted: 05/18/2017] [Indexed: 01/30/2023]
Abstract
Background Transgender women living with HIV infection experience poorer health outcomes across the HIV continuum of care. While disparities are well established, their underlying mechanisms are not well understood. This study examined the HIV continuum of care (also known as the HIV treatment cascade), including linkage and engagement in care and health status among transgender women and cisgender women and cisgender men living with HIV. METHOD Case-control matching was applied to a cohort of 1101 people living with HIV; 70 transgender women living with HIV were matched on years since testing HIV positive with cisgender women and cisgender men. Participants provided measures indicative of the HIV treatment cascade that included linkage and engagement in care, receiving and adhering to antiretroviral therapy (ART), and HIV viral suppression. Common correlates of HIV-related health status: depression symptoms, HIV-related stress, alcohol and drug use, healthcare conspiracy beliefs, medical mistrust, emotional social support and tangible social support, were also assessed. RESULTS Transgender women were significantly less likely to receive ART, were less adherent to ART and had poorer HIV viral suppression than cisgender persons. Multivariable models demonstrated that health disparities were predicted by transgender women having poorer tangible social support over and above the other correlates of health outcomes. CONCLUSION Tangible support is amenable by interventions such as building and strengthening supportive networks and paraprofessional services. Socially supportive interventions should be considered critical in efforts to decrease HIV health disparities among transgender women.
Collapse
Affiliation(s)
- Seth C Kalichman
- Department of Psychology, University of Connecticut, 406 Babbidge Road, Storrs, CT 06269
| | - Dominica Hernandez
- Department of Psychology, University of Connecticut, 406 Babbidge Road, Storrs, CT 06269
| | - Stephanie Finneran
- Department of Psychology, University of Connecticut, 406 Babbidge Road, Storrs, CT 06269
| | - Devon Price
- Department of Psychology, University of Connecticut, 406 Babbidge Road, Storrs, CT 06269
| | - Redd Driver
- Department of Psychology, University of Connecticut, 406 Babbidge Road, Storrs, CT 06269
| |
Collapse
|
|
40
|
Pisanic N, Rahman A, Saha SK, Labrique AB, Nelson KE, Granger DA, Granger SW, Detrick B, Heaney CD. Development of an oral fluid immunoassay to assess past and recent hepatitis E virus (HEV) infection. J Immunol Methods 2017; 448:1-8. [PMID: 28478117 DOI: 10.1016/j.jim.2017.04.012] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/10/2017] [Revised: 04/26/2017] [Accepted: 04/27/2017] [Indexed: 12/18/2022]
Abstract
BACKGROUND Hepatitis E virus (HEV) infection causes significant morbidity and mortality worldwide, particularly among pregnant women. In clinical settings blood-based testing protocols are commonly used to diagnose HEV infection, but in community settings such invasive sampling can hinder study participation and limit discovery of the ecology and natural history of HEV infection. Oral fluid is a non-invasive biospecimen that can harbor pathogen-specific antibodies and has the potential to replace blood-based testing protocols. OBJECTIVES To develop an immunoassay to assess past and recent HEV infection that uses oral fluid instead of serum or plasma. METHODS The assay was validated using paired oral fluid and serum samples collected from 141 patients who presented either with (n=76) or without (n=65) symptoms of acute viral hepatitis at a clinical diagnostics center in Dhaka, Bangladesh. The sensitivity and specificity of the oral fluid-based immunoassay for HEV IgG (past HEV infection) and HEV IgA (recent HEV infection) antibodies was calculated in reference to Wantai's (Beijing Wantai) serum-based HEV enzyme-linked immunosorbent assay (ELISA) kits for IgG and IgM antibodies, respectively. RESULTS The sensitivity and specificity of the oral fluid-based immunoassay for HEV-IgG antibodies were 98.7% and 98.4%, respectively. The sensitivity and specificity of the oral fluid-based immunoassay for HEV IgA were 89.5% and 98.3%, respectively. CONCLUSIONS The high concordance of our non-invasive oral fluid-based immunoassays (HEV IgG and HEV IgA) with commercial high-performance serum HEV ELISA kits (IgG and IgM) means that population-based surveillance of past and recent HEV infection could be expanded to improve understanding of its ecology and natural history.
Collapse
Affiliation(s)
- Nora Pisanic
- Department of Environmental Health and Engineering, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
| | - Atiqur Rahman
- Department of Microbiology, Dhaka Shishu (Children's) Hospital, Dhaka 1207, Bangladesh
| | - Samir K Saha
- Department of Microbiology, Dhaka Shishu (Children's) Hospital, Dhaka 1207, Bangladesh
| | - Alain B Labrique
- Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Population, Family, and Reproductive, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
| | - Kenrad E Nelson
- Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
| | - Douglas A Granger
- Institute for Interdisciplinary Salivary Bioscience, University of California at Irvine, Irvine, CA, USA; Department of Pediatrics, Johns Hopkins University, School of Medicine, Baltimore, MD, USA; Department of Acute and Chronic Care, Johns Hopkins University School of Nursing, Baltimore, MD, USA; Research and Technology Center, Salimetrics, LLC, Carlsbad, CA, USA
| | - Steve W Granger
- Research and Technology Center, Salimetrics, LLC, Carlsbad, CA, USA
| | - Barbara Detrick
- Department of Pathology, Johns Hopkins University, School of Medicine, Baltimore, MD, USA
| | - Christopher D Heaney
- Department of Environmental Health and Engineering, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Institute for Interdisciplinary Salivary Bioscience, University of California at Irvine, Irvine, CA, USA.
| |
Collapse
|
|
41
|
Handanagic S, Sevic S, Barbaric J, Dominkovic Z, Dakovic Rode O, Begovac J, Bozicevic I. Correlates of anti-hepatitis C positivity and use of harm reduction services among people who inject drugs in two cities in Croatia. Drug Alcohol Depend 2017; 171:132-139. [PMID: 28088084 DOI: 10.1016/j.drugalcdep.2016.11.028] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/08/2016] [Revised: 11/21/2016] [Accepted: 11/21/2016] [Indexed: 01/10/2023]
Abstract
BACKGROUND We assessed correlates of anti-hepatitis C (anti-HCV) positivity and utilization of needle and syringe exchange programs (NSEP) and opioid agonist treatment (OAT) among people who inject drugs (PWID) in two Croatian cities. METHODS We conducted a cross-sectional study using respondent-driven (RDS) sampling among PWID in Rijeka (N=255) and Split (N=399). We used RDS-weighted population estimates and multivariable logistic regression to explore correlates of anti-HCV positivity and NSEP and OAT utilization. RESULTS Seventy-eight percent (78.0%) of PWID in Rijeka and 61.5% in Split had been tested previously for HCV, while 21.5% and 7.0%, respectively, were tested for HCV in the past 12 months. Among PWID who report being infected with HCV, 24.9% in Rijeka and 11.3% in Split received anti-HCV treatment. In Rijeka, PWID who utilized NSEP and, in Split, those who were ever imprisoned, had higher odds of anti-HCV positivity. In Rijeka, PWID on OAT were more likely to use non-sterile injecting equipment and to inject for longer than 10 years. PWID enrolled in NSEP were more likely to inject opioid agonist medication (OAM) and less likely to use non-sterile injecting equipment. More than half of PWID reported misuse of OAM in the past month, while out of PWID enrolled in OAT, 65.4% in Rijeka and 88.7% in Split injected OAM in the month prior to the survey. CONCLUSIONS Key findings of the paper point to the need to scale up HCV testing and treatment, improve access to NSEP and the quality of OAT provisions in order to prevent its misuse among PWID.
Collapse
Affiliation(s)
- Senad Handanagic
- WHO Collaborating Centre for HIV Strategic Information, Andrija Stampar School of Public Health, School of Medicine, University of Zagreb, Rockefellerova ulica 4, 10000 Zagreb, Croatia.
| | - Sandra Sevic
- Department of Sociology, Faculty of Humanities and Social Sciences, University of Zagreb, Ivana Lucica 3, 10000 Zagreb, Croatia.
| | - Jelena Barbaric
- WHO Collaborating Centre for HIV Strategic Information, Andrija Stampar School of Public Health, School of Medicine, University of Zagreb, Rockefellerova ulica 4, 10000 Zagreb, Croatia.
| | - Zoran Dominkovic
- Non-governmental Organization for Sexual and Gender Minorities Iskorak, Petrinjska ulica 27, 10000 Zagreb, Croatia.
| | - Oktavija Dakovic Rode
- University Hospital for Infectious Diseases "Dr. Fran Mihaljevic", School of Medicine, University of Zagreb, Mirogojska cesta 8, 10000 Zagreb, Croatia.
| | - Josip Begovac
- University Hospital for Infectious Diseases "Dr. Fran Mihaljevic", School of Medicine, University of Zagreb, Mirogojska cesta 8, 10000 Zagreb, Croatia.
| | - Ivana Bozicevic
- WHO Collaborating Centre for HIV Strategic Information, Andrija Stampar School of Public Health, School of Medicine, University of Zagreb, Rockefellerova ulica 4, 10000 Zagreb, Croatia.
| |
Collapse
|
|
42
|
Easterbrook PJ. Who to test and how to test for chronic hepatitis C infection - 2016 WHO testing guidance for low- and middle-income countries. J Hepatol 2016; 65:S46-S66. [PMID: 27641988 DOI: 10.1016/j.jhep.2016.08.002] [Citation(s) in RCA: 87] [Impact Index Per Article: 9.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/09/2016] [Accepted: 08/09/2016] [Indexed: 12/11/2022]
Abstract
Testing and diagnosis of hepatitis C virus (HCV) infection is the gateway for access to both treatment and prevention services, and crucial for an effective hepatitis epidemic response. In contrast to HIV, a systematic approach to hepatitis C testing has been fragmented and limited to a few countries, and there remains a large burden of undiagnosed cases globally. Key challenges in the current hepatitis testing response, include lack of simple, reliable, and low cost diagnostic tests, laboratory capacity, and testing facilities; inadequate data to guide country-specific hepatitis testing approaches and who to test; stigmatization and social marginalization of some groups with or at risk of viral hepatitis; and lack of international or national guidelines on hepatitis testing for resource-limited settings. New tools to support the hepatitis global response include the 2016 Global Hepatitis Health Sector Strategy which include targets for testing and diagnosis, and World Health Organization (WHO) 2016 hepatitis testing guidelines for adults, adolescents, and children in low- and middle-income countries. The testing guidance complements recent published WHO guidance on the prevention, care and treatment of chronic hepatitis C and hepatitis B infection. These testing guidelines outline the public health approach to strengthening and expanding current testing practices for HCV and HBV and address what serological and virological assays to use, and who to test, as well as interventions to promote linkage to prevention and care after testing. They are intended for use across all age groups and populations. See boxes for key recommendations. Future directions and innovations in viral hepatitis testing include use of point-of-care assays for nucleic acid testing (NAT) and core antigen; validation of dried blood spots specimens with different commercial serological and NAT assays; multiplex and polyvalent platforms for integrated testing of HIV, HBV and HCV; and potential for self-testing.
Collapse
Affiliation(s)
- Philippa J Easterbrook
- Global Hepatitis Programme, HIV Department, World Health Organization, Geneva, Switzerland.
| | -
- Global Hepatitis Programme, HIV Department, World Health Organization, Geneva, Switzerland
| |
Collapse
|
|
43
|
Vandegrift KJ, Critchlow JT, Kapoor A, Friedman DA, Hudson PJ. Peromyscus as a model system for human hepatitis C: An opportunity to advance our understanding of a complex host parasite system. Semin Cell Dev Biol 2016; 61:123-130. [PMID: 27498234 DOI: 10.1016/j.semcdb.2016.07.031] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/11/2016] [Revised: 07/26/2016] [Accepted: 07/28/2016] [Indexed: 02/07/2023]
Abstract
Worldwide, there are 185 million people infected with hepatitis C virus and approximately 350,000 people die each year from hepatitis C associated liver diseases. Human hepatitis C research has been hampered by the lack of an appropriate in vivo model system. Most of the in vivo research has been conducted on chimpanzees, which is complicated by ethical concerns, small sample sizes, high costs, and genetic heterogeneity. The house mouse system has led to greater understanding of a wide variety of human pathogens, but it is unreasonable to expect Mus musculus to be a good model system for every human pathogen. Alternative animal models can be developed in these cases. Ferrets (influenza), cotton rats (human respiratory virus), and woodchucks (hepatitis B) are all alternative models that have led to a greater understanding of human pathogens. Rodent models are tractable, genetically amenable and inbred and outbred strains can provide homogeneity in results. Recently, a rodent homolog of hepatitis C was discovered and isolated from the liver of a Peromyscus maniculatus. This represents the first small mammal (mouse) model system for human hepatitis C and it offers great potential to contribute to our understanding and ultimately aid in our efforts to combat this serious public health concern. Peromyscus are available commercially and can be used to inform questions about the origin, transmission, persistence, pathology, and rational treatment of hepatitis C. Here, we provide a disease ecologist's overview of this new virus and some suggestions for useful future experiments.
Collapse
Affiliation(s)
- Kurt J Vandegrift
- Department of Biology, The Pennsylvania State University, University Park, PA 16802, United States; Center for Infectious Disease Dynamics, The Pennsylvania State University, University Park, PA 16802, United States.
| | - Justin T Critchlow
- Department of Biology, The Pennsylvania State University, University Park, PA 16802, United States; Center for Infectious Disease Dynamics, The Pennsylvania State University, University Park, PA 16802, United States
| | - Amit Kapoor
- Center for Vaccines and Immunity, Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH 43205, United States
| | - David A Friedman
- Department of Biology, The Pennsylvania State University, University Park, PA 16802, United States; Center for Infectious Disease Dynamics, The Pennsylvania State University, University Park, PA 16802, United States
| | - Peter J Hudson
- Department of Biology, The Pennsylvania State University, University Park, PA 16802, United States; Center for Infectious Disease Dynamics, The Pennsylvania State University, University Park, PA 16802, United States
| |
Collapse
|
|
44
|
Calvo-García F, Giralt-Vázquez C, Calvet-Roura A, Carbonells-Sánchez X. Riesgo de suicidio en población sin hogar. CLINICA Y SALUD 2016. [DOI: 10.1016/j.clysa.2016.05.002] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
|
|
45
|
Andries AC, Duong V, Ong S, Ros S, Sakuntabhai A, Horwood P, Dussart P, Buchy P. Evaluation of the performances of six commercial kits designed for dengue NS1 and anti-dengue IgM, IgG and IgA detection in urine and saliva clinical specimens. BMC Infect Dis 2016; 16:201. [PMID: 27184801 PMCID: PMC4867535 DOI: 10.1186/s12879-016-1551-x] [Citation(s) in RCA: 29] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/13/2015] [Accepted: 05/09/2016] [Indexed: 12/29/2022] Open
Abstract
Background Rapid diagnostic tests (RDTs) have been commercialized in order to help physicians in dengue diagnosis. Until recently, only blood samples were used for those tests but it has been shown in several studies that urine and saliva can also be employed for dengue diagnosis. RDTs for the detection of NS1 antigen and anti-dengue IgG, IgM and IgA in urine and saliva specimens have thus been developed by Standard Diagnostics. The aim of this study was to evaluate the performances these new commercial assays. Methods Two panels of clinical specimens were used: one for the evaluation of the NS1-detection devices and the second for the evaluation of the antibody-detection kits. Each panel consisted of urine and saliva specimens collected sequentially from 86 patients with a confirmed dengue infection. A total of 291 saliva and 440 urine samples were included in the NS1-evaluation panel and 530 saliva and 528 urine specimens constituted the antibody-evaluation panel. All samples were tested in parallel by in-house ELISAs and by the commercial RDTs. Results The RDTs demonstrated an overall sensitivity of 15.5 %/27.9 %/10.7 % for NS1/IgG/IgA detection in urine samples and 20.4 %/ 34.8 %/11 %/6.2 % for NS1/IgG/IgM/IgA detection in saliva samples. Compared to the in-house NS1 ELISA, the results obtained with the NS1 RDT demonstrated a good correlation with urine samples (kappa coefficient: 0.88) but not with saliva specimens (kappa coefficient: 0.28). RDTs designed for antibody detection in saliva and urine were extremely specific (100 %), but less sensitive than the in-house ELISAs (i.e., reduction of the overall sensitivity by 12.2 % for the RDT designed for IgG detection in urine and by 23.7 % for the RDT detecting anti-DENV IgM in saliva). IgM were not detected in urine, either by RDT or ELISA. Conclusions Although the RDTs evaluated here offer an apparently attractive approach for dengue diagnosis, this study suggests that these new commercial kits would require further improvement to increase the sensitivity. Electronic supplementary material The online version of this article (doi:10.1186/s12879-016-1551-x) contains supplementary material, which is available to authorized users.
Collapse
Affiliation(s)
- Anne-Claire Andries
- Institut Pasteur in Cambodia, International Network of Pasteur Institutes, Virology Unit, Phnom Penh, Cambodia
| | - Veasna Duong
- Institut Pasteur in Cambodia, International Network of Pasteur Institutes, Virology Unit, Phnom Penh, Cambodia
| | - Sivuth Ong
- Institut Pasteur in Cambodia, International Network of Pasteur Institutes, Virology Unit, Phnom Penh, Cambodia
| | - Sopheaktra Ros
- Institut Pasteur in Cambodia, International Network of Pasteur Institutes, Virology Unit, Phnom Penh, Cambodia
| | - Anavaj Sakuntabhai
- Institut Pasteur, Functional Genetics of Infectious Diseases Unit, Paris, France.,Centre National de la Recherche Scientifique, Unité de Recherche Associée 3012, Paris, France
| | - Paul Horwood
- Institut Pasteur in Cambodia, International Network of Pasteur Institutes, Virology Unit, Phnom Penh, Cambodia
| | - Philippe Dussart
- Institut Pasteur in Cambodia, International Network of Pasteur Institutes, Virology Unit, Phnom Penh, Cambodia
| | - Philippe Buchy
- Institut Pasteur in Cambodia, International Network of Pasteur Institutes, Virology Unit, Phnom Penh, Cambodia. .,GlaxoSmithKline, Vaccines R&D, Singapore, Singapore.
| |
Collapse
|
|
46
|
Lacroix N, Barraud H, Gillet C, Di Patrizio P, Bronowicki JP, Schwan R, Laprévote V. [Which place for point-of-care screening tests in the diagnosis of hepatitis C infection among drug users?]. Presse Med 2016; 45:431-7. [PMID: 26947910 DOI: 10.1016/j.lpm.2016.01.024] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/22/2015] [Revised: 01/14/2016] [Accepted: 01/20/2016] [Indexed: 11/28/2022] Open
Abstract
Hepatitis C is a severe disease, which often evolves into chronicity and for which there is no vaccine available. Therefore its screening is essential, especially among drug users who are the main reservoir of the hepatitis C virus (HCV). Current guidelines for screening are based on the detection of total anti-HCV antibodies (Ab) by means of third generation EIA. This test is performed in a laboratory from a venous sample. Alternative methods have been recently developed, including point-of-care tests (POCT) that offer many advantages. Their excellent diagnostic performance, their quick results and their ease of use by a large number of professionals are arguments in favor of widespread use of these tests. The expected benefits of the use of POCT are individual (better knowledge of HCV status, better access to care and treatment) but also collective (reduction of morbidity and mortality related to HCV and its cost in terms of public health) Because of their clinical interest, POCT should be refunded as well as the currently recommended screening test. In order to optimize their ease of use, POCT use should be integrated into an organized screening and hepatology follow-up system.
Collapse
Affiliation(s)
- Noémie Lacroix
- CHRU de Nancy, maison des Addictions, 54000 Nancy, France
| | - Hélène Barraud
- CHRU de Nancy, service d'hépato-gastro-entérologie, 54000 Nancy, France
| | | | | | | | - Raymund Schwan
- CHRU de Nancy, maison des Addictions, 54000 Nancy, France; CHRU de Nancy, centre d'investigation clinique Pierre-Drouin, CIC-Inserm 9501, 54000 Nancy, France; Centre psychothérapique de Nancy, 54000 Nancy, France; Université Lorraine, Ingres, EA 7298, 54000 Nancy, France
| | - Vincent Laprévote
- CHRU de Nancy, maison des Addictions, 54000 Nancy, France; CHRU de Nancy, centre d'investigation clinique Pierre-Drouin, CIC-Inserm 9501, 54000 Nancy, France; Centre psychothérapique de Nancy, 54000 Nancy, France; Université Lorraine, Ingres, EA 7298, 54000 Nancy, France.
| |
Collapse
|
|
47
|
Beckwith CG, Kurth AE, Bazerman LB, Patry EJ, Cates A, Tran L, Noska A, Kuo I. A pilot study of rapid hepatitis C virus testing in the Rhode Island Department of Corrections. J Public Health (Oxf) 2016; 38:130-7. [PMID: 25736438 PMCID: PMC4750523 DOI: 10.1093/pubmed/fdv023] [Citation(s) in RCA: 45] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND The correctional population bears a heavy burden of hepatitis C virus (HCV) infection necessitating expansion of HCV testing and treatment opportunities. Rapid HCV testing provides point-of-care antibody results and may be ideal for correctional facilities, particularly jails, where persons are often incarcerated for short periods of time, yet feasibility has not been established. METHODS We conducted a pilot study of a rapid HCV testing algorithm among short-term inmates with unknown HCV status. Participants completed a questionnaire, viewed an informational video and underwent rapid HCV testing and confirmatory testing, when indicated. Persons with chronic infection were referred to community care after release. Baseline characteristics, risk behaviors, test results and linkage were examined by descriptive analyses. RESULTS Two hundred and fifty-two inmates were enrolled and 249 completed all study activities. Twenty-five participants (10%) had reactive rapid tests and 23 (92%) completed confirmatory testing. 15/23 (65%) had detectable HCV RNA, but only 4 linked to care after release. Persons with reactive HCV tests were more likely to be White (P = 0.01) and to have ever injected (P < 0.0001) and/or recently injected (P < 0.0001) drugs. CONCLUSIONS Rapid HCV testing within jails is feasible, identifies previously unrecognized cases of HCV infection, and implementation should be considered. Low rates of linkage to care after release remain a barrier to care.
Collapse
Affiliation(s)
- Curt G. Beckwith
- The Miriam Hospital/Alpert Medical School of Brown University, Providence, Rhode Island 02906, USA
| | | | | | | | - Alice Cates
- George Washington University, Washington, DC, USA
| | - Liem Tran
- The Miriam Hospital, Providence, Rhode Island, USA
| | - Amanda Noska
- The Miriam Hospital/Alpert Medical School of Brown University, Providence, Rhode Island 02906, USA
| | - Irene Kuo
- George Washington University, Washington, DC, USA
| |
Collapse
|
|
48
|
Intentional Medication Nonadherence Because of Interactive Toxicity Beliefs Among HIV-Positive Active Drug Users. J Acquir Immune Defic Syndr 2016; 70:503-9. [PMID: 26226250 DOI: 10.1097/qai.0000000000000776] [Citation(s) in RCA: 43] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/17/2023]
Abstract
BACKGROUND Drug use poses significant challenges to medical management of HIV infection. Although most research has focused on the influence of intoxication on unintentional adherence to HIV treatment, drug use may also lead to intentional nonadherence, particularly when individuals believe that mixing medications with drugs is harmful. This study examined whether interactive toxicity beliefs predict nonadherence to antiretroviral therapy (ART) over a prospective period of adherence monitoring. METHODS Men and women living with HIV who screened positive for drug use and were being treated with ART (n = 530) completed computerized self-interviews and 3 prospective unannounced pill counts to measure ART adherence and provided urine specimens for drug screening and HIV viral load results from medical records. RESULTS Results showed that 189 (35%) participants indicated that they intentionally miss their ART when they are using drugs. These participants also reported common beliefs regarding the perceived hazards of mixing HIV medications with alcohol and other drugs. Multivariable models controlled for demographic and health characteristics and frequency of alcohol use showed that intentional nonadherence predicted poorer ART adherence over the prospective month and also predicted poorer treatment outcomes as indexed by unsuppressed HIV viral load. CONCLUSIONS These findings extend previous research to show that interactive toxicity beliefs and intentional nonadherence play a significant role in medication nonadherence for a substantial number of people living with HIV and should be actively addressed in HIV clinical care.
Collapse
|
|
49
|
Majem B, Rigau M, Reventós J, Wong DT. Non-coding RNAs in saliva: emerging biomarkers for molecular diagnostics. Int J Mol Sci 2015; 16:8676-98. [PMID: 25898412 PMCID: PMC4425103 DOI: 10.3390/ijms16048676] [Citation(s) in RCA: 57] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/23/2015] [Revised: 04/02/2015] [Accepted: 04/08/2015] [Indexed: 01/05/2023] Open
Abstract
Saliva is a complex body fluid that comprises secretions from the major and minor salivary glands, which are extensively supplied by blood. Therefore, molecules such as proteins, DNA, RNA, etc., present in plasma could be also present in saliva. Many studies have reported that saliva body fluid can be useful for discriminating several oral diseases, but also systemic diseases including cancer. Most of these studies revealed messenger RNA (mRNA) and proteomic biomarker signatures rather than specific non-coding RNA (ncRNA) profiles. NcRNAs are emerging as new regulators of diverse biological functions, playing an important role in oncogenesis and tumor progression. Indeed, the small size of these molecules makes them very stable in different body fluids and not as susceptible as mRNAs to degradation by ribonucleases (RNases). Therefore, the development of a non-invasive salivary test, based on ncRNAs profiles, could have a significant applicability to clinical practice, not only by reducing the cost of the health system, but also by benefitting the patient. Here, we summarize the current status and clinical implications of the ncRNAs present in human saliva as a source of biological information.
Collapse
Affiliation(s)
- Blanca Majem
- Research Unit in Biomedicine and Translational Oncology, Lab 209, Collserola Building, Vall Hebron Research Institute (VHIR) and University Hospital, Pg. Vall Hebron 119-129, 08035 Barcelona, Spain.
| | - Marina Rigau
- Research Unit in Biomedicine and Translational Oncology, Lab 209, Collserola Building, Vall Hebron Research Institute (VHIR) and University Hospital, Pg. Vall Hebron 119-129, 08035 Barcelona, Spain.
| | - Jaume Reventós
- Research Unit in Biomedicine and Translational Oncology, Lab 209, Collserola Building, Vall Hebron Research Institute (VHIR) and University Hospital, Pg. Vall Hebron 119-129, 08035 Barcelona, Spain.
- IDIBELL-Bellvitge Biomedical Research Institute & Universitat Internacional de Catalunya, 08908 Barcelona, Spain.
| | - David T Wong
- Center for Oral/Head & Neck Oncology Research, University of California, Los Angeles, CA 90095, USA.
| |
Collapse
|
|
50
|
Khuroo MS, Khuroo NS, Khuroo MS. Diagnostic accuracy of point-of-care tests for hepatitis C virus infection: a systematic review and meta-analysis. PLoS One 2015; 10:e0121450. [PMID: 25816332 PMCID: PMC4376712 DOI: 10.1371/journal.pone.0121450] [Citation(s) in RCA: 63] [Impact Index Per Article: 6.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/11/2014] [Accepted: 02/01/2015] [Indexed: 12/11/2022] Open
Abstract
BACKGROUND Point-of-care tests provide a plausible diagnostic strategy for hepatitis C infection in economically impoverished areas. However, their utility depends upon the overall performance of individual tests. METHODS A literature search was conducted using the metasearch engine Mettā, a query interface for retrieving articles from five leading medical databases. Studies were included if they employed point-of-care tests to detect antibodies of hepatitis C virus and compared the results with reference tests. Two reviewers performed a quality assessment of the studies and extracted data for estimating test accuracy. FINDINGS Thirty studies that had evaluated 30 tests fulfilled the inclusion criteria. The overall pooled sensitivity, specificity, positive likelihood-ratio, negative likelihood-ratio and diagnostic odds ratio for all tests were 97.4% (95% CI: 95.9-98.4), 99.5% (99.2-99.7), 80.17 (55.35-116.14), 0.03 (0.02-0.04), and 3032.85 (1595.86-5763.78), respectively. This suggested a high pooled accuracy for all studies. We found substantial heterogeneity between studies, but none of the subgroups investigated could account for the heterogeneity. Genotype diversity of HCV had no or minimal influence on test performance. Of the seven tests evaluated in the meta-regression model, OraQuick had the highest test sensitivity and specificity and showed better performance than a third generation enzyme immunoassay in seroconversion panels. The next highest test sensitivities and specificities were from TriDot and SDBioline, followed by Genedia and Chembio. The Spot and Multiplo tests produced poor test sensitivities but high test specificities. Nine of the remaining 23 tests produced poor test sensitivities and specificities and/or showed poor performances in seroconversion panels, while 14 tests had high test performances with diagnostic odds ratios ranging from 590.70 to 28822.20. CONCLUSIONS Performances varied widely among individual point-of-care tests for diagnosis of hepatitis C virus infection. Physicians should consider this while using specific tests in clinical practice.
Collapse
Affiliation(s)
| | - Naira Sultan Khuroo
- Digestive Diseases Centre, Dr Khuroo Medical Clinic, Srinagar, Kashmir, J&K, India
| | | |
Collapse
|