A method to alleviate false-positive results of the Elecsys HIV combi PT assay

Abstract

To explore the effects of urea dissociation on reducing false-positive results of the Elecsys HIV combi PT assay. A retrospective analysis was used to evaluate the false-positive rate of the Elecsys HIV combi PT assay. Six false-positive sera, six positive sera and six sera from patients with early HIV infection were collected. Dissociation was performed using 1 mol/L, 2 mol/L, 4 mol/L, 6 mol/L, or 8 mol/L urea, and HIV screening assay were then detected to select the appropriate concentration of urea dissociation. Next, 55 false-positive sera and 15 sera from early HIV infection were used to verify the best concentration of urea to achieve dissociation. Retrospective analysis showed that the COI of the Elecsys HIV combi PT assay in false-positive sera ranged from 1.0 to 200.0, and approximately 97.01%(227/234) of false-positive sera were in the range of 1.0–15.0. The avidity index (AI) in positive and false-positive sera decreased as the urea dissociation concentration increased. When the dissociation concentration was 6 mol/L, the AI of false-positive serum was between 0.0234 and 0.2567, and the AI of early HIV infection sera was between 0.4325 and 0.5017. The difference in AI between false-positive and positive samples was significant. When negativity was defined as an AI of less than 0.3970, the sensitivity and specificity were 100.0% and 100.0%, respectively. Urea-mediated dissociation could significantly reduce the false-positive rate of the Elecsys HIV combi PT assay with a low COI. Our findings provided a reference for distinguishing positive and false-positive of the Elecsys HIV combi PT assay.

Evaluation of a two-test strategy for HIV screening in a low-prevalence setting and the indications for optimizing clinical management

“…The FPR was 43.4% (199/459), and it was high and similar to other reports studying HIV screening and low prevalence settings [ 15 , 16 ]. Some researches focused on assessing the role of the S/CO ratio in reducing the frequency of false-positive results [ [17] , [18] , [19] ]. We found the optimal S/CO positive threshold was 8.82 in our population which provided a sensitivity of 100% and a PPV of 90.91%.…”

Data on the Relationships of Signal-To-Cutoff Ratios of Elecsys HIV Antigen/Antibody and Elecsys Syphilis Assays to Subsequent Confirmatory Testing at an Academic Medical Center

“…1 (panel B) shows a flow diagram of the HIV testing in the retrospective study. Similar to syphilis antibodies, multiple studies have shown an association of the S/CO value of HIV screening tests with subsequent verification of HIV diagnosis using confirmatory testing and clinical information [7] , [8] , [9] , [10] , [11] , [12] , [13] , [14] , [15] . Confirmation testing commonly used in the United States and some other countries includes antibody differentiation assays (in the present study was the Bio-Rad Geenius assay) and HIV RNA PCR.…”