Genscreen ultra hiv ag ab

Mobile health clinics across the study area facilitated data collection. Research nurses compiled participants’ medical histories, including prior HIV, tuberculosis, hypertension, and diabetes diagnoses. Blood samples from 17,949 participants were collected for HIV testing using the Genscreen Ultra HIV Ag-Ab enzyme immunoassay [Bio-Rad]. The HIV-1 RNA viral load was subsequently measured for immunoassay-positive samples, resulting in 6093 successful tests. Samples with detectable viral load >40 copies/ml (n = 1323) underwent whole-genome sequencing at the University of Oxford.

During the first clinical visit, participants had biochemical (liver transaminases) and haematological (full blood count) tests and the following serological tests: HBeAg and antibody to HBeAg (anti-HBeAb; Architect i1000 SR, Abbott, North Chicago, IL, USA), HIV-1 and HIV-2 antibodies (EIA, Genscreen ULTRA HIV Ag-Ab, Bio-Rad, Hercules, CA, USA), and anti-HDV (ETI-AB-DELTAK-2, DiaSorin, Saluggia VC, italy) were analysed in a subgroup of participants. HBV DNA was quantified using an in-house real-time PCR (detection limit 50 IU/ml), the accuracy of which was validated against a commercial quantitative PCR (qPCR; Abbott, Wiesbaden, Germany).²¹ (link)

The Mozambican national algorithm was used for diagnosis of HIV, composed of two sequential immunochromatographic rapid tests, the Determine^TM HIV-1/2 (Alere Medical CO., Ltd Japan) for screening, followed by the UniGold^® HIV-1/2 (Trinity Biotech, Bray, Ireland), for confirmation of positive results. In case of discordant HIV results, a fourth-generation test was performed by using an enzyme immunoassay ELISA (Genscreen^™ ULTRA HIV Ag-Ab; Bio-Rad, France). Syphilis testing was performed by using non-treponemal test card, RPR (Macro-Vue RPR Card Tests, BD, Ireland) for screening and confirmed by a treponemal test TPPA (Serodia TP-PA, Fujirebio INC, Japan). Hepatitis B surface antigen (HBsAg) testing was preformed using an enzyme immunoassay EIA (Genscreen^TM HBsAg EIA 3.0). Screening rapid tests were performed using the OraQuick HCV Rapid antibody test (OraSure Technologies, Inc. Bethlehem, PA USA), and confirmation for anti-Hepatitis C was performed using an anti-HCV ELISA (Ortho(R) HCV Version 3.0 ELISA Test System). Malaria testing was performed by using an immunochromatographic test (Clearview Malaria, Inverness Medical, South Africa).

Each volunteer underwent several biological analyses. Screening for HIV infection was carried out according to the sequential algorithm combining Alere Determine HIV-1/2 test (Alere Medical Co. Ltd., Matsudo-shi, Chiba-ken, Japan), and Uni-Gold™ HIV (Trinity Biotech Manufacturing Ltd., Bray, Ireland). In case of indeterminate results, the sample was subjected to additional HIV testing (Genscreen™ ULTRA HIV Ag-Ab, Bio-Rad, Marnes-La-Coquette, France). Hepatitis B surface antigen (HBs Ag) was detected by Monalisa HBs Ag (Bio-Rad). Syphilis serology used nontreponemal RPR test (Carbon, Cypress Diagnostics, Belgium) and treponemal TPHA test (Syphagen, Biokit, Barcelona, Spain). Herpes simplex virus type 2-gD-specific serology was carried out by the HSV-2 BioElisa kit (Biokit), as described [8 (link)]. Bacterial vaginosis was detected by Gram staining of fresh vaginal swabs using the Nugent score, as previously described [27 (link)].