Evaluation of the performance of the Abbott ARCHITECT HIV Ag/Ab Combo Assay.

摘要: Abstract Background Worldwide, many countries test for HIV infection using combination assays that simultaneously detect p24 antigen and antibodies. One such assay, the ARCHITECT® Ag/Ab Combo Assay (ARCHITECT), has recently been approved by Food Drug Administration (FDA) use in United States. Objective To evaluate performance of ARCHITECT on well-characterized specimens from four CDC-funded studies. Study design We evaluated 3386 HIV-infected, 7551 HIV-uninfected, 58 acute (AHI) specimens. HIV-infected were repeatedly reactive enzyme immunoassay (EIA) Western blot (WB) or positive nucleic acid amplification testing (NAAT). HIV-uninfected EIA- NAAT-negative. AHI seronegative indeterminate (using antibody-based EIAs, rapid tests WB) NAAT-positive. All de-identified sent to Abbott Diagnostics with ARCHITECT. results compared original study characterizations used assess overall sensitivity specificity also AHI. false-positive sufficient quantity retested. Results Based initial test, was 99.94% (95% confidence interval [CI]: 99.79, 99.99) 98.78% CI: 98.51–99.01). Repeat resulted corrected 99.50% 99.31, 99.64). Also, 48 (83%) detected this screening assay. Conclusion The assay are very high most AHIs Use may improve number identified relative existing FDA-approved HIV-antibody only based serologic assays, particularly incidence populations.