title: 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.
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.
  
  
  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.
authors.affiliation: Institute of Virology, National Reference Centre for Hepatitis C, University Hospital Essen, University of Duisburg-Essen, Essen, Germany. stefan.ross@uni-due.de
authors.forename: R Stefan
authors.initials: RS
authors.lastname: Ross
authors.forename: Oumaima
authors.initials: O
authors.lastname: Stambouli
authors.forename: Nico
authors.initials: N
authors.lastname: Grüner
authors.forename: Ulrich
authors.initials: U
authors.lastname: Marcus
authors.forename: Wei
authors.initials: W
authors.lastname: Cai
authors.forename: Weidong
authors.initials: W
authors.lastname: Zhang
authors.forename: Ruth
authors.initials: R
authors.lastname: Zimmermann
authors.forename: Michael
authors.initials: M
authors.lastname: Roggendorf
mesh_terms: D001769:Blood / Q000821:virology*; D003890:Desiccation; D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification; D016174:Hepacivirus / Q000302:isolation & purification; D006509:Hepatitis B / Q000175:diagnosis* / Q000821:virology; D006515:Hepatitis B virus / Q000302:isolation & purification; D006526:Hepatitis C / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods*