Geenius hiv 1 2 confirmatory assay

HIV testing was carried out for all participants in accordance with the Kenyan Ministry of Health serial HIV testing algorithm with finger prick collection of whole blood for rapid testing using the Determine™ Assay (Abbott Laboratories, Matsudo, Japan), with a reactive result confirmed using First Response® (Premier Medical Corporation limited, Mumbai, India). Discordant HIV results were further tested using the fourth-generation Geenius™ HIV 1/2 Confirmatory Assay (Bio-Rad Laboratories, Johannesburg, South Africa). Upon enrollment in the RV393 cohort, urine samples were collected for Neisseria gonorrhoeae and Chlamydia trachomatis nucleic acid amplification testing using the Aptima Combo-2 (Hologic Corporation, San Diego, CA, USA). Serum samples were screened for syphilis using the Impact™ RPR carbon agglutination test kit (Alere Technologies, Jena, Germany). All testing was conducted according to package inserts.

All eight HIV RDTs (Determine HIV-1/2 [Determine; Alere, USA], Uni-Gold HIV [Uni-Gold; Trinity Biotech, Ireland], Genie Fast HIV 1/2 [Genie Fast; BioRad Laboratories, USA], Vikia HIV 1/2 [Vikia; bioMérieux, France], HIV 1/2 Stat-Pak [Stat-Pak; Chembio, USA], Insti HIV-1/HIV-2 antibody test [Insti; bioLytical, Canada], SD Bioline HIV 1/2 3.0 [SD Bioline; Standard Diagnostics, South Korea], and First Response HIV Card Test1-2.O [First Response; PMC, India]) and two simple confirmatory assays (ImmunoComb II HIV 1&2 CombFirm [ImmunoComb Combfirm; Orgenics, Alere, Israel] and Geenius HIV 1/2 confirmatory assay [Geenius; Bio-Rad, USA]) were performed at ITM on all collected plasma samples from the six study sites, as reported elsewhere (14 (link)). All tests were performed by six trained laboratory technicians. Each test was read by two technicians, each of whom was blind to the results reported by the other reader and to the reference standard result. When the two readers gave discordant results, a third reader was consulted to resolve the discrepancy. The details of the tests, as well as their performance per origin of specimens in our evaluation, are presented elsewhere (14 (link)).

Information regarding prior HIV-testing was requested from all participants during the HIV-testing survey. Participants were asked to self-report their HIV status and to present documentation of their last HIV tests, such as the pregnancy card, child health card, HIV care card, or HIV counseling and testing card. Following national testing recommendations, participants that, at the time of the study visit, did not know their HIV status or had tested HIV-negative more than three months before the study visit, were offered testing according to the national HIV-testing algorithm, which includes two serial HIV rapid diagnostic tests from different manufacturers (Determine and Unigold) [13 –15 ]. For all HIV-positive participants, a dry blood spot (DBS) was collected on filter paper to perform a laboratory confirmation test (Bio-Rad Geenius HIV1/2 Confirmatory assay) [16 ]. The study HIV counselors provided pre- and post-test counseling, and all newly diagnosed women were referred to the nearest health unit for HIV care and treatment. The study counselors provided a referral guide and and recorded the data of the patient and of the nearest health unit or the one of preference in a study logbook, in order to facilite linkage to care.