When employing the transcription-mediated amplification method for screening blood donors, there are some non-discriminatory reactive results which are screening assay reactive but HBV-DNA discriminatory assay negative. This raises concerns regarding the possibility of false positives among donors, which may lead to permanent deferral of blood donors and affect blood supply. This study aimed to elucidate the infection status of these non-discriminatory reactive blood donors and develop and validate a model to predict individualized hepatitis B status to establish an optimal screening strategy.

Supplementary tests were conducted on initial non-discriminating reactive donations to determine their HBV infection status, including repeat testing, viral load, serological marker detection, and follow-up. Primary clinical variables of the donors were recorded. Based on the Akaike information criterion, a stepwise forward algorithm was used to identify the predictive factors for information and construct a predictive model. The optimal screening strategy was determined through cost-effectiveness analysis.

At the Blood Center of Zhejiang Province, 435 cases of initial non-discriminatory reactive donations were collected over two successive periods and sub-categorized through repeated testing into the following three groups: non-repeated positive group, non-discriminated positive group, and non-repeated HBV-DNA positive group. The HBV discriminatory rate increased after repeated testing (110/435, 25.29%). According to supplementary tests, the HBV-DNA positivity rate was 65.52% (285/435), and occult HBV infection was a significantly different among groups (χ2 = 93.22, p < 0.01). The HBV serological markers and viral load in the non-repeated positive group differed from those in the other two groups, with a lower viral load and a higher proportion of false positives. The predictive model constructed using a stepwise forward algorithm exhibited high discrimination, good fit, high calibration, and effectiveness. A cost-effectiveness analysis indicated that utilizing repeated discriminatory testing and the predictive model is an extremely beneficial screening approach for non-discriminatory reactive blood donors.

Nearly two-third (65.52%) of the non-discriminatory reactive blood donors were HBV-DNA positive. Our innovative approach of constructing a predictive model as a supplementary screening strategy, combined with repeated discriminatory experiments, can effectively identify the infection status of non-discriminatory reactive blood donors, thereby increasing the safety of blood transfusions.

This study aimed to assess the efficacy of individual-donation nucleic acid testing (ID-NAT) in detecting occult hepatitis B virus infection (OBI) among anti-HBc positive blood donors, compared to minipool nucleic acid testing (MP-NAT).

The present study analyzed data from the Shandong Blood Center in China during the period from January 2018 to June 2022, where HBsAg-negative blood donors were screened using the 6-sample minipool nucleic acid testing (6-sample MP NAT) method. NAT-positive samples underwent subsequent anti-HBc and anti-HBs testing. Approximately 5000 samples that passed the nucleic acid mixing test were randomly selected for anti-HBc testing, and over 100 anti-HBc positive samples underwent individual donor nucleic acid testing (ID-NAT). Any HBV DNA positive samples detected by ID-NAT were subsequently confirmed using alternative nucleic acid testing methods.

Among 220,445 HBsAg-negative blood donors, the positivity rate of HBV DNA detection using the 6-sample minipool nucleic acid testing (MP NAT) method was found to be 0.031% (69/220,445). Of the 67 HBV DNA positive samples, 55 (82.09%) and 25 (37.31%) were found to be positive for anti-HBc and anti-HBs, respectively, using the supplementary chemiluminescent microparticle immunoassay (CMIA). Among the 4797 HBsAg-negative/MP NAT-negative samples, 909 (18.95%) tested positive for anti-HBc. Further NAT testing was performed on 164 arbitrarily selected anti-HBc-positive/MP HBV DNA-negative samples, revealing a HBV DNA positivity rate of 1.22% (2/164).

Using individual donation nucleic acid testing can significantly increase the detection rate of occult hepatitis B virus infection in anti-HBc-positive blood donors, resulting in a detection rate of 0.22% (1.22 × 0.1895). This rate is 8.10 times higher than the detection rate achieved by mixed testing methods (0.031%) [calculated as (0.22 + 0.031)/0.031]. Therefore, it is recommended to perform single HBV DNA testing on anti-HBc-positive blood donors, discard plasma with weakly positive or negative anti-HBs but positive anti-HBc, or avoid transfusing anti-HBc-positive plasma to recipients with weakly positive or negative anti-HBs to prevent HBV infection.

Since 2010, the Blood Center of Zhejiang province, China, has conducted a pilot nucleic acid amplification testing (NAT) screening of blood donors for Hepatitis B virus (HBV), Hepatitis C virus (HCV), and Human immunodeficiency virus (HIV). This study aims to assess the results of NAT testing over 10 years to establish the effects and factors influencing NAT yields of HBV, HCV, and HIV.

Blood donations from seven different blood services were screened for HBV DNA, HCV RNA, and HIV RNA using 6 mini pools (6MP) or individual donation (ID)-NAT method between August 1, 2010, and December 31, 2019, at the NAT centralized screening center. We compared 3 transcription-mediated amplification (TMA) assays and 2 polymerase chain reaction (PCR) assays. Further, HBV, HCV, and HIV NAT yields were calculated and donor characteristics and prevalence of HBV NAT yields analyzed. Donors with HCV and HIV NAT yield were also followed up.

1916.31 per million donations were NAT screening positive overall. The NAT yields for HBV, HCV, HIV and non-discriminating reactive were 1062.90 per million, 0.97 per million, 1.45 per million, and 850.99 per million, respectively, which varied in the seven blood services and different years. HBV NAT yields were higher than those of HCV and HIV and varied across demographic groups. Risk factors included being male, old age, low education level, and first-time donors. We found no differences in NAT yields of HBV, HCV, and HIV between the 3 TMA and 2 PCR assays; nonetheless, statistically, significant differences were noted between the five assays.

In summary, NAT screening in blood donations reduces the risk of transfusion-transmitted infections and shortens the window period for serological marker screening. Therefore, a sensitive NAT screening method, ID-NAT workflow, and recruitment of regular low-risk donors are critical for blood safety.

Utilizing kidneys from donors with hepatitis B is one way to alleviate the current organ shortage situation. However, the risk of hepatitis B virus (HBV) transmission remains a challenge that undermines the chance of organs being used. This is particularly true with hepatitis B surface antigen (HBsAg) positive donors despite the comparable long-term outcomes when compared with standard donors. To reduce the risk of HBV transmission, a comprehensive approach is needed. This includes assessment of donor risk, optimal allocation to the proper recipient, appropriate immunosuppressive regimen, optimizing the prophylactic therapy, and post-transplant monitoring. This review provides an overview of current evidence of kidney transplants from donors with HBsAg positivity and outlines the challenge of this treatment. The topics include donor risk assessment by adopting the nucleic acid test coupled with HBV DNA as the HBV screening, optimal recipient selection, importance of hepatitis B immunity, role of nucleos(t)ide analogues, and hepatitis B immunoglobulin. A summary of reported long-term outcomes after kidney transplantation and proposed criteria to utilize kidneys from this group of donors was also defined and discussed.

Hepatitis B virus (HBV) infection and emergence of drug resistance have remained one of the major public health puzzles. This study determined circulating HBV genotypes and nucleoside analog resistance to provide information in choosing the best therapy.

A cross-sectional study was conducted among jaundiced patients visiting Coast General Teaching and Referral Hospital during the period between February and August 2018. A total of 222 patients were recruited and screened for HBsAg following the ethical procedure. Viral DNA was extracted from positive samples, partial HBV-pol gene amplified, and directly sequenced and analyzed using web-based software prediction to genotypic resistance mutations.

Forty-seven (21.2%) of the 222 patients tested positive for HBV. Of the 45 samples successfully sequenced, 12 (26.4%) had drug resistance. Six patients (13.3%) had rtV173L, rtL180M, and rtM204V mutations; five subjects (11.1%) with rtL180M and rtM204V while 1 patient (2.2%) had rtM204V mutations. Therefore, all patients had cross-resistance to lamivudine and entecavir. Phylogenetic analysis revealed that HBV genotype A1 35 (74.5%) was predominant. HBV genotypes A3, B, and C2 each occurred once (0.02%). In addition, existence of new HBV genotypes A3, B, and C2 1 (0.02%) in the country was also detected.

Findings suggest that HBV-infected patients should not be put on lamivudine monotherapy. These patients should be on a combination therapy; tenofovir plus lamivudine or emtricitabine to prevent emergence of drug resistance variants. In addition, HBV genotype A1 remains the most predominant genotype in this region. The detected new genotypes variants indicate a possible existence of 0.02% circulation within the population.

To assess the prognostic significance of enhancement rate (ER) measured by contrast-enhanced ultrasonography (CEUS) in patients with hepatocellular carcinoma (HCC) undergoing radiofrequency ablation (RFA).

A total of 253 patients with single primary HCC undergoing preoperative CEUS and RFA were enrolled in this study. The ER were evaluated though pretreatment CEUS. After a mean follow-up of 36.8 ± 10.2 months, the correlation of ER measured by CEUS and survival after RFA was analyzed by univariate and multivariate analysis. The optimal cutoff ER value to predict survival was determined using receiver-operating characteristic analysis.

Mean follow-up period for all 253 patients was 36.8 ± 10.2 months, 31.2% of patients had died at endpoint. The optimal cutoff ER value predicting survival was 2.2 dB/s. Univariate analysis demonstrated that patients with a high ER level had poorer OS (62.8 months vs 48.8 months, P = 0.02) and recurrence-free survival (RFS = 60.2 months vs 47.4 months, P = 0.03) than patients with a low ER level. ER measured by CEUS also been confirmed as independent risk factor for overall survival (hazard ratio [HR], 1.87; 95% confidence interval [95% CI], 1.21-7.25; P < 0.01) and RFS (HR, 1.67; 95% CI, 1.08-6.21; P < 0.01) in multivariate analysis enrolling gender, BMI, tumor size, antiviral therapy, HBV DNA, histological differentiation, Child-Pugh score and tumor node metastasis (TNM) stage.

ER measured by CEUS was a significant predictive factor for survival after RFA for HCC.

Chinese blood centers use Hepatitis B surface antigen (HBsAg) rapid test (RT) in pre-donation and two rounds of screening with different enzyme-linked immunosorbent assays in post-donation. Nucleic acid testing (NAT) on screening non-reactive (SC-) donations has been gradually implemented since 2010. Yet RT+ and SC-/NAT+ donors are seldom included in hepatitis B virus (HBV) positive rate estimates in Chinese blood donors.

We performed HBsAg neutralization test (NT) on whole blood (WB) with pre-donation RT+ results and post-donation screening reactive (SC+) samples from Mianyang and Chongqing in 2015. The annual totals of pre- and post-donation NT+ donors were combined with the annual totals of SC-/NAT+ donors to derive the estimated HBV positive rates.

In Mianyang and Chongqing, 59.4% and 68.2% of RT+ donors in Jan-Aug 2015 contributed for NT, 95.5% and 97.2% of which were NT+ respectively. In 2015, 422 and 667 donors from Mianyang and Chongqing respectively were HBsAg RT+, yielding estimated 403 and 648 pre-donation RT+/NT+ deferrals. 411 and 668 post-donation SC+ samples were NT tested from Mianyang and Chongqing, of which 249 and 323 were NT+ respectively. An estimated 63 donors in Mianyang and 88 donors in Chongqing were SC-/NAT+. The estimated HBV confirmed positive rate in blood donors are 1.59% in Mianyang and 1.01% in Chongqing.

Pre-donation HBsAg RT effectively intercepts donations from HBV infected donors. Using NT confirmatory results from RT+, SC+ and SC-/NAT+ donors, this study provides a model for more accurate estimation for HBV positive rates in China.

To analyze the risk and reason of false-negative HBV DNA results of NAT reagents among blood donations of China and discuss the necessity of two amplification targets for HBV DNA tests among donations. In this study, samples that showed discordant results on two commercially available assay platforms were further detected by established in-house methods based on conserved regions of the HBV genome. The HBV concentration of these samples was determined using two commercially available reagents. The samples with high titers of HBV were detected by an in-house method. The samples showing high Ct differences between two regions in the in-house method were further sequenced and aligned with primers and probes. The results showed that the established method has a good detection performance. The mismatch between reverse primers and sample sequences led to decreased detection capacity of S and C regions by the in-house method, but it could be compensated by another region. Among the false-negative samples detected by commercial reagents, most were because of low titers; however, there were 7 samples with HBV DNA concentrations much higher than the LOD of the commercial reagents, which may be due to mismatch of the primer or probe. This study highlights the potential risk of HBV false-negative detection by commercial NAT reagents. The dual-target assay may be helpful for HBV screening and reduce the risk of false-negative detection.

To analyze clinical significance of preoperative liver stiffness measurement (LSM) by FibroScan in postcurative resection hepatitis B virus (HBV) related hepatocellular carcinoma (HCC).

A total of 263 patients underwent preoperative LSM and curative operation for primary HBV-positive HCC were enrolled. The correlation between preoperative LSM and survival was analyzed.

All patients were stratified into two groups using the optimal cut-off value (13.2 kPa) of LSM using the receiver-operating characteristic. Patients with an LSM ≥13.2 kPa had poorer overall survival (median, 61.3 vs 48.2 months, hazard ratio: 0.15; p = 0.009) and recurrence-free survival (median, 60.4 vs 47.0 months; hazard ratio: 0.32; p = 0.011) than patients with an LSM <13.2 kPa and LSM also have been confirmed as independent predictor for survival for HCC.

This could potentially guide patient stratification and individualized treatment.

Preoperative LSM can be considered as an independent prognostic factor for HBV-positive HCC after curative resection.