Abstract:
In a study, the reliability, sensitivity, and specificity of the MicroTrak II HIV-1/HIV-2 EIA (MT II) were compared to licensed EIAs and Western Blot (WB). 2490 sera from various populations in the US, Africa, and India were evaluated at 3 different sites using the MT II and licensed HIV-1/HIV-2 EIAs (Genetic Systems or Abbott). All repeatedly reactive sera were reconfirmed by WB for HIV-1. Sera that were indeterminate by WB, had discrepant results, or were previously known to be HIV-2 positive were retested using a licensed HIV-2 EIA (Genetic Systems). All reactive samples were confirmed by HIV-2 WB. Discrepant samples were also tested using a peptide assay (Select HIV). Final interpretation of serological results was primarily based on WB and, in some cases, RIPA, PCR, and culture. WB and other confirmatory testing identified 910 HIV-1/HIV-2 positive samples and 1580 HIV-1/HIV-2 negative samples. MT II detected all 910 positive samples for a sensitivity of 100% and the licensed HIV-1/HIV-2 EIAs detected 904 positive samples for a sensitivity of 99.3%. MT II characterized 1574 negative samples as negative for a specificity of 99.6% and the licensed EIAs detected 1565 negative samples as negative for a specificity of 99.1%. The 6 false positives by MT II were all sera from Africa. The MicroTrak II HIV-1/HIV-2 EIA is a reliable assay that has a slightly higher sensitivity and specificity compared to other licensed EIAs.
Keywords: Africa Blotting, Western/METHODS Comparative Study False Positive Reactions Human HIV Antigens/*BLOOD HIV Seropositivity/BLOOD/*DIAGNOSIS HIV-1/*ISOLATION & PURIF HIV-2/*ISOLATION & PURIF *Immunoenzyme Techniques India Predictive Value of Tests Sensitivity and Specificity United States ABSTRACT 941030
M94A0835
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