Prospective Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Sep 7, 2016; 22(33): 7604-7612
Published online Sep 7, 2016. doi: 10.3748/wjg.v22.i33.7604
Dried blood spots, valid screening for viral hepatitis and human immunodeficiency virus in real-life
Belinda K Mössner, Benjamin Staugaard, Janne Jensen, Søren Thue Lillevang, Peer B Christensen, Dorte Kinggaard Holm
Belinda K Mössner, Benjamin Staugaard, Peer B Christensen, Department of Infectious Diseases, Odense University Hospital, 5000 Odense, Denmark
Janne Jensen, Department of Medicine, Lillebaelt Hospital, Kolding, 6000 Kolding, Denmark
Søren Thue Lillevang, Dorte Kinggaard Holm, Department of Clinical Immunology, Odense University Hospital, 5000 Odense, Denmark
Peer B Christensen, Department of Clinical Research, University of Southern Denmark, 5000 Odense, Denmark
Author contributions: Mössner BK, Lillevang ST, Christensen PB and Holm DK designed the study; Mössner BK, Staugaard B, Jensen J and Christensen PB performed the experiments; Lillevang ST and Holm DK contributed new analytic tools/methods; Mössner BK analyzed the data; and Mössner BK, Christensen PB and Holm DK wrote the paper; all authors revised the final manuscript.
Supported by Abbvie, Denmark.
Institutional review board statement: The study was reviewed and approved by the Scientific Institutional Review Board in the southern region of Denmark (Project ID: S-20140128).
Informed consent statement: All study participants provided written informed consent prior to study enrollment.
Conflict-of-interest statement: Peer Brehm Christensen has received research grants from Abbvie and Gilead; no other authors have any conflicts of interest to disclose.
Data sharing statement: There are no additional data available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Peer B Christensen, PhD, Associate Professor, Department of Infectious Diseases, Odense University Hospital, Sdr. Boulevard 29, DK 5000 Odense C, Denmark. peer.christensen@dadlnet.dk
Telephone: +45-6541-1559 Fax: +45-6611-7418
Received: March 29, 2016
Peer-review started: May 5, 2016
First decision: May 30, 2016
Revised: June 27, 2016
Accepted: July 31, 2016
Article in press: July 31, 2016
Published online: September 7, 2016
Processing time: 158 Days and 22.9 Hours
Abstract
AIM

To detect chronic hepatitis B (CHB), chronic hepatitis C (CHC) and human immunodeficiency virus (HIV) infections in dried blood spot (DBS) and compare these samples to venous blood sampling in real-life.

METHODS

We included prospective patients with known viral infections from drug treatment centers, a prison and outpatient clinics and included blood donors as negative controls. Five drops of finger capillary blood were spotted on filter paper, and a venous blood sample was obtained. The samples were analyzed for HBsAg, anti-HBc, anti-HBs, anti-HCV, and anti-HIV levels as well as subjected to a combined nucleic acid test (NAT) for HBV DNA, HCV RNA and HIV RNA.

RESULTS

Samples from 404 subjects were screened (85 CHB, 116 CHC, 114 HIV and 99 blood donors). DBS had a sensitivity of > 96% and a specificity of > 98% for the detection of all three infections. NAT testing did not improve sensitivity, but correctly classified 95% of the anti-HCV-positive patients with chronic and past infections. Anti-HBc and anti-HBS showed low sensitivity in DBS (68% and 42%).

CONCLUSION

DBS sampling, combined with an automated analysis system, is a feasible screening method to diagnose chronic viral hepatitis and HIV infections outside of the health care system.

Keywords: Dried blood spot; Real-life; Screening; Hepatitis B; Hepatitis C; Human immunodeficiency virus; People who inject drugs; Drug-users; Prisoners

Core tip: This study shows that it is feasible to combine serology and nucleic acid screening for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) infections in one dried blood sample (DBS) collected in real life and analyzed using a modern laboratory platform. We observed a sensitivity and specificity of > 96% for HBV, HCV, and HIV and correctly classified 95% of all HCV patients into past vs chronic infections compared to simultaneously collected venous blood samples. The study confirms that DBSs are feasible samples in outreach clinics and confirms the high sensitivity and specificity of previous laboratory-based studies.