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Open Access Research

Detection of infections with hepatitis B virus, hepatitis C virus, and human immunodeficiency virus by analyses of dried blood spots - performance characteristics of the ARCHITECT system and two commercial assays for nucleic acid amplification

R Stefan Ross1*, Oumaima Stambouli1, Nico Grüner1, Ulrich Marcus2, Wei Cai2, Weidong Zhang2, Ruth Zimmermann2 and Michael Roggendorf1

Author Affiliations

1 Institute of Virology, National Reference Centre for Hepatitis C, University Hospital Essen, University of Duisburg-Essen, Essen, Germany

2 Department of Infectious Disease Epidemiology, Robert Koch Institute, Berlin, Germany

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Virology Journal 2013, 10:72  doi:10.1186/1743-422X-10-72

Published: 5 March 2013

Abstract

Background

Nowadays, dried blood spots (DBS) are primarily used to obtain diagnostic access to risk collectives such as intravenous drug users, who are prone to infections with hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Before DBS analyses can be used in this diagnostic context, however, a comprehensive evaluation of its performance characteristics must be conducted. To the best of our knowledge, the current study presents for the first time such essential data for the Abbott ARCHITECT system, which is currently the worldwide leading platform in this field of infection diagnostics.

Methods

The investigation comprised 1,762 paired serum/DBS samples and a total of 3,524 determinations with the Abbott ARCHITECT HBsAg, anti-HBc, anti-HBs, anti-HCV and HIV-1-p24-antigen/anti-HIV 1/2 assays as well as with the artus HBV LC PCR and VERSANT HCV RNA qualitative (TMA) tests.

Results

In the context of DBS testing, a specificity of 100% was recorded for the seven serological and molecular biological assays. The analytical sensitivity of HBsAg, anti-HBc, anti-HBs, anti-HCV, HIV-1-p24-antigen/anti-HIV 1/2, HBV DNA, and HCV RNA detections in DBS eluates was 98.6%, 97.1%, 97.5%, 97.8%, 100%, 93%, and 100%, respectively.

Discussion/conclusions

The results obtained indicate that it is today possible to reliably detect HBsAg, anti-HBc, anti-HBs, anti-HCV and HIV-1-p24 antigen/anti-HIV 1/2 with state-of-the-art analytical systems such as the Abbott ARCHITECT in DBS eluates even when a comparatively high elution volume of 1,000 μl is used. They also provide evidence for the inherent analytical limits of DBS testing, which primarily concern the anti-HBc/anti-HBs system for individuals with HIV infections and nucleic acid tests with relatively low analytical sensitivity.

Keywords:
Hepatitis B virus infection; Hepatitis C virus infection; Human immunodeficiency virus infection; Dried blood spots; Intravenous drug users; Serological testing; Molecular testing; Real-time PCR; Transcription-mediated amplification