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

Abstract 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...

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Bibliographic Details
Published in:Scandinavian journal of infectious diseases 2014-09, Vol.46 (9), p.660-664
Main Authors: Sommese, Linda, Sabia, Chiara, Paolillo, Rossella, Parente, Delia, Capuano, Maria, Iannone, Carmela, Cavalca, Francesco, Schiano, Concetta, Vasco, Maria, De Pascale, Maria Rosaria, Casamassimi, Amelia, Napoli, Claudio
Format: Article
Language:English
Subjects:
Adult
Blood Donors
CLIA
concordance
Diagnostic Tests, Routine - methods
DNA, Viral - blood
Female
Hepacivirus - immunology
Hepatitis B - diagnosis
Hepatitis B Surface Antigens - blood
Hepatitis B virus - immunology
Hepatitis C - diagnosis
Hepatitis C Antibodies - blood
HIV Antibodies - blood
HIV Antigens - blood
HIV Infections - diagnosis
HIV-1 - immunology
Humans
Immunoassay - methods
Luminescent Measurements - methods
Male
Mass Screening - methods
Middle Aged
Predictive Value of Tests
RNA, Viral - blood
Sensitivity and Specificity
Serological screening
Young Adult
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Summary:Abstract 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.
ISSN:0036-5548
1651-1980
DOI:10.3109/00365548.2014.926564