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

Virology Journal

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

[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

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

Others  :  1151442
DOI  :  10.1186/1743-422X-10-72

 received in 2012-06-26, accepted in 2013-02-27,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Ross et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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