Screening tests for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus in blood donors: Evaluation of two chemiluminescent immunoassay systems

Linda Sommese, Chiara Sabia, Rossella Paolillo, Delia Parente, Maria Capuano, Carmela Iannone, Francesco Cavalca, Concetta Schiano, Maria Vasco, Maria Rosaria De Pascale, Amelia Casamassimi, Claudio Napoli

Research output: Contribution to journalArticle


Automated chemiluminescent immunoassays (CLIAs) are useful for the detection of hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus 1/2 antigen/antibodies (HIV 1/2 Ag/Ab) in blood donor screening. Eight hundred and forty serum samples were tested for hepatitis B surface antigen (HBsAg), HCV antibodies (anti-HCV), and HIV1/2 Ag/Ab in parallel using 2 different CLIAs (Abbott Architect i2000SR and Roche Cobas e411). The concordance between the 2 systems was high (Cohen's kappa 0.97 for HBsAg, 0.77 for anti-HCV, 0.92 for HIV1/2 Ag/Ab) and the specificity and the positive predictive value were comparable. Among the 12 discrepant results, 11 were false-positive and 1 (reactive by Architect) was true-positive for anti-HCV. Positivity for HBV DNA, HCV RNA, and HIV RNA was recorded in 90.9%, 38.9%, and 100% of true-positive samples, respectively. This study represents the first stringent comparison between Architect i2000SR and Cobas e411 in blood donors. We observed a good correlation and high agreement among HBV, HCV, and HIV with the 2 automated systems.

Original languageEnglish
Pages (from-to)660-664
Number of pages5
JournalScandinavian Journal of Infectious Diseases
Issue number9
Publication statusPublished - 2014



  • Blood donors
  • CLIA
  • Concordance
  • Serological screening

ASJC Scopus subject areas

  • Microbiology (medical)
  • Immunology and Microbiology(all)
  • Infectious Diseases
  • Medicine(all)

Cite this