FALSE-NEGATIVE RESULTS IN HIV-1/2

M. VIGNOLES,; M. BIBINI,; A. SORRENTINO,; S. SÁNCHEZ PUCH,; M. GÓMEZ CARRILLO,; H. SALOMÓN

Paris, Francia

Conferencia; The 2nd IAS Conference on HIV Pathogenesis and treatment,; 2003

International AIDS Society

The sensitivity of screening assays for HIV antibody detection is extremely important to reduce false-negative results. Due to our finding of some HIV infected patients whose sera failed to react with a commercial HIV antibody test, the characteristics of these sera were analyzed. All of them were HIV-1 seropositive by CDC interpretative criteria but had no reactivity to the envelope glycoprotein gp-41 in a Western blot test. In this study, eight commercial assays for HIV-1/2 antibodies screening were evaluated using plasma specimens of individuals with known HIV status which lacked reactivity by Western blot to gp-41. None of the patients had evidence of recent HIV infection. The assays were 4 rapid tests: HIVCHEK( System 3 Test Kit (Ortho Diagnostic Systems Inc), Seratec« HIV Test (Bio Analytical), DIA HIV 1+2 (Wiener Laboratorios S.A.I.C), Determine( HIV-1/2 (Abbott Laboratories), 3 enzyme-linked immunosorbent assays: Bioelisa HIV-1+2 rec (Biokit S.A.), Murex HIV-1.2.O (Murex Biotech Ltd), Cobas Core HIV combi EIA (Roche Diagnostics) and 1 microparticle enzyme immunoassay: Abbott HIV ¢ gO EIA (Abbott Laboratories). Eight out of 17 HIV positive specimens (47%) were reactive with Seratec« HIV Test, 8 out of 13 (61.5%) with DIA HIV 1+2, 3 out of 19 (15.8%) with Bioelisa HIV-1+2 rec, 2 out of 18 (11.1%) with HIVCHEK( System 3 Test Kit, 12 out of 12 (100%) with Determine( HIV-1/2, 12 out of 12 (100%) with Abbott HIV ¢ gO EIA, 11 out of 11 (100%) with Murex HIV-1.2.O and 12 out of 12 (100%) with Cobas Core HIV combi EIA. These results indicate that screening assays for HIV antibodies are not equal in performance and sensitivity and  can give false-negative results when used with some specimens which lack antibodies against gp41. This kind of specimens represent  aproximately 3% of the HIV positive specimens diagnosed in our laboratory. For these reasons, we consider that HIV screening assays must be evaluated with all specimen types in the settings of their intended use. These results indicate that screening assays for HIV antibodies are not equal in performance and sensitivity and  can give false-negative results when used with some specimens which lack antibodies against gp41. This kind of specimens represent  aproximately 3% of the HIV positive specimens diagnosed in our laboratory. For these reasons, we consider that HIV screening assays must be evaluated with all specimen types in the settings of their intended use. Eight out of 17 HIV positive specimens (47%) were reactive with Seratec« HIV Test, 8 out of 13 (61.5%) with DIA HIV 1+2, 3 out of 19 (15.8%) with Bioelisa HIV-1+2 rec, 2 out of 18 (11.1%) with HIVCHEK( System 3 Test Kit, 12 out of 12 (100%) with Determine( HIV-1/2, 12 out of 12 (100%) with Abbott HIV ¢ gO EIA, 11 out of 11 (100%) with Murex HIV-1.2.O and 12 out of 12 (100%) with Cobas Core HIV combi EIA. These results indicate that screening assays for HIV antibodies are not equal in performance and sensitivity and  can give false-negative results when used with some specimens which lack antibodies against gp41. This kind of specimens represent  aproximately 3% of the HIV positive specimens diagnosed in our laboratory. For these reasons, we consider that HIV screening assays must be evaluated with all specimen types in the settings of their intended use. These results indicate that screening assays for HIV antibodies are not equal in performance and sensitivity and  can give false-negative results when used with some specimens which lack antibodies against gp41. This kind of specimens represent  aproximately 3% of the HIV positive specimens diagnosed in our laboratory. For these reasons, we consider that HIV screening assays must be evaluated with all specimen types in the settings of their intended use.