Performances of four fourth‐generation human immunodeficiency virus‐1 screening assays

Abstract

Fourth-generation human immunodeficiency virus-1 (HIV-1) screening assays have improved sensitivity, but vary in performance characteristics. The purpose of this study was to evaluate four different fourth-generation HIV-1 assays. These assays included the AxSYM HIV Ag/Ab Combo (Abbott diagnostics, Delkenheim, Germany), ARCHITECT HIV Ag/Ab Combo (Abbott), Elecsys 2010 HIV Combi (Roche Diagnostics GmbH, Mannheim, Germany), and Elecsys HIV Combi PT (Roche). A total of 1,306 samples that included 1,225 clinical samples and 81 samples consisting of seroconversion panels, an HIV-1 p24 antigen sensitivity panel, and dilution series of HIV-1 lysates and HIV-1 antibodies were tested. All of the assays had sensitivities of 100% on clinical samples. The specificities of the AxSYM, ARCHITECT, Elecsys 2010 HIV Combi, and Elecsys HIV Combi PT were 99.6, 99.6, 99.0, and 99.5%, respectively. Of the 81 samples with different levels of HIV antigen or antibody and/or subtypes, Elecsys HIV Combi PT and ARCHITECT HIV Ag/Ab Combo showed better analytical sensitivities than the other two assays. In summary, the performance characteristics of AxSYM, ARCHITECT, and Elecsys HIV Combi PT were comparable and satisfactory for clinical samples. ARCHITECT HIV Ag/Ab Combo and Elecsys HIV Combi PT have the higher analytical sensitivities, and would be preferable for reducing the window period.

A retrospective analysis of the application of the Elecsys®HIV combi PT assay in southern China

“…In current diagnostic algorithms, the fourth‐generation assays are implemented worldwide as an initial test. Nevertheless, multiple studies indicated that test performance may vary significantly in different demographic factors and geographic regions …”

“…Nevertheless, multiple studies indicated that test performance may vary significantly in different demographic factors and geographic regions. 11,12 As understanding the performance of fourth-generation assay in local region is pivotal to interpret the test result correctly, in the present study, we set out to analyze the Elecsys ® HIV combi PT assay in Shaocong Liang and Guihua Deng contributed equally our hospital with a situation of low HIV prevalence. The Elecsys ® HIV combi PT assay had been used in our laboratory for more than 2 years, some problems emerged during the testing processes.…”

Reduction of the HIV Seroconversion Window Period and False Positive Rate by Using ADVIA Centaur HIV Antigen/Antibody Combo Assay

“…Newer fourth-generation HIV assays should be validated for the known limitation of previous assays. According to the recent studies [16, 17], the average specificity of the fourth-generation assay was from 99.5% to 99.9%, which was equivalent to that of the third-generation assays.…”

“…The p24 antigen, CHIV, and other combo assays should meet the analytical sensitivity at least 2 IU/mL using WHO standard, for approval of HIV combo assays in the Conformite Europeenne [22]. The newer fourth-generation HIV assays showed 1.13 IU/mL of lowest detection limit using HIV p24 antigen sensitivity panel [17]. Although we could not evaluate the analytical sensitivity of the ADVIA Centaur CHIV assay in this study, we may expect that it has the comparable sensitivity with other fourth-generation HIV assays.…”

Detection of an Acute HIV-1 Infection Case in the Last Day of Diagnostic Window through a Combination of Two Fourth-Generation Screening Assays on a Brazilian Public Healthy Institution: We Close the Window

“…Samples with signal to cut-off (S/CO) values greater than or equal to 1.0 are considered reactive and samples with S/CO values less than 1.0 are considered nonreactive. ARCHITECT HIV Ag/Ab Combo has high analytical sensitivities (sensibility 100%, specificity 99.6%) and would be preferable for reducing the window period [2].…”