title: 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 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.
authors: From the 1 U.O.C. Immunohaematology, Transfusion Medicine and Transplant Immunology, Azienda Ospedaliera Universitaria, Second University of Naples.
authors: Linda
authors: L
authors: Sommese
authors: Chiara
authors: C
authors: Sabia
authors: Rossella
authors: R
authors: Paolillo
authors: Delia
authors: D
authors: Parente
authors: Maria
authors: M
authors: Capuano
authors: Carmela
authors: C
authors: Iannone
authors: Francesco
authors: F
authors: Cavalca
authors: Concetta
authors: C
authors: Schiano
authors: Maria
authors: M
authors: Vasco
authors: Maria Rosaria
authors: MR
authors: De Pascale
authors: Amelia
authors: A
authors: Casamassimi
authors: Claudio
authors: C
authors: Napoli
mesh_terms: D000328:Adult; D001782:Blood Donors; D004279:DNA, Viral / Q000097:blood; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005260:Female; D015483:HIV Antibodies / Q000097:blood; D015488:HIV Antigens / Q000097:blood; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000276:immunology; D016174:Hepacivirus / Q000276:immunology; D006509:Hepatitis B / Q000175:diagnosis*; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000276:immunology; D006526:Hepatitis C / Q000175:diagnosis*; D018937:Hepatitis C Antibodies / Q000097:blood; D006801:Humans; D007118:Immunoassay / Q000379:methods; D008163:Luminescent Measurements / Q000379:methods*; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D011237:Predictive Value of Tests; D012367:RNA, Viral / Q000097:blood; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D004279:DNA, Viral; D015483:HIV Antibodies; D015488:HIV Antigens; D006514:Hepatitis B Surface Antigens; D018937:Hepatitis C Antibodies; D012367:RNA, Viral
keywords: CLIA; Serological screening; blood donors; concordance