[Evaluation of COBAS CORE anti-HIV-1/HIV-2 EIA DAGS for the detection of antibodies to HIV by COBAS CORE].
COBAS CORE Anti-HIV-1/HIV-2 EIA DAGS (CORE HIV-1/2) for the detection of antibodies to HIV-1 and HIV-2 was evaluated by a fully automated immunoassay system, COBAS CORE II (Roche Diagnostics K.K.). The sensitivity of CORE HIV-1/2 was assessed in comparison with PA1/2, Enzygnost, VIDAS and AxSYM by testing serial two-fold dilutions of HIV-1 and HIV-2 sera. CORE HIV-1/2 showed the highest sensitivity than other methods. The agreements of the results of anti-HIV antibodies determinations between the CORE HIV-1/2 and other methods, PA1/2, Enzygnost, VIDAS, and AxSYM, were 99.4%, 100%, 100%, and 99.7%, respectively in the tests for anti-HIV-1 antibody. In the tests for anti-HIV-2, all results were agreed at 100%. Discrepant samples which showed a negative by CORE HIV-1/2 and a positive by PA1/2 and AxSYM were clearly negative of anti-HIV-1 antibody by p24 ACA, PCR, Western blot, and continuous clinical studies. This assay showed excellent coefficients of variation for both within-run and day to day precision. The determination of anti-HIV antibodies was not interfered with hemoglobin, bilirubin, and chylemia. We conclude that the excellent specificity and sensitivity of the CORE HIV-1/2 make the CORE HIV-1/2 a suitable method for diagnosis of HIV-1 and HIV-2 infections in clinical laboratories.
Kodama
T
T
Department of Clinical Laboratory Medicine, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya 466-0064, Japan.
Nada
T
T
Yamamoto
H
H
Morishita
Y
Y
Iinuma
Y
Y
Ichiyama
S
S
D005069:Evaluation Studies as Topic; D015483:HIV Antibodies / Q000032:analysis*; D015497:HIV-1 / Q000276:immunology*; D015498:HIV-2 / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic