1. Screening tests for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus in blood donors: evaluation of two chemiluminescent immunoassay systems
- Author
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Maria Capuano, Amelia Casamassimi, Claudio Napoli, Francesco Cavalca, Delia Parente, Rossella Paolillo, Concetta Schiano, Chiara Sabia, Maria Vasco, Linda Sommese, Carmela Iannone, Maria Rosaria De Pascale, Sommese, Linda, Sabia, C, Paolillo, R, Parente, D, Capuano, M, Iannone, C, Cavalca, F, Schiano, C, Vasco, M, De Pascale, Mr, Casamassimi, Amelia, and Napoli, Claudio
- Subjects
Microbiology (medical) ,Adult ,Male ,HBsAg ,Hepatitis B virus ,HIV Antigens ,Hepacivirus ,Hepatitis C virus ,Blood Donors ,HIV Infections ,HIV Antibodies ,medicine.disease_cause ,Sensitivity and Specificity ,Young Adult ,Predictive Value of Tests ,medicine ,Humans ,Mass Screening ,Mass screening ,Immunoassay ,Hepatitis B Surface Antigens ,General Immunology and Microbiology ,biology ,business.industry ,Diagnostic Tests, Routine ,virus diseases ,General Medicine ,Hepatitis C ,Hepatitis B ,Hepatitis C Antibodies ,Middle Aged ,biology.organism_classification ,medicine.disease ,Virology ,digestive system diseases ,Infectious Diseases ,Immunology ,DNA, Viral ,Luminescent Measurements ,HIV-1 ,RNA, Viral ,Female ,business - 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.
- Published
- 2014