Determine hiv 1 2

This was an observational study with data collected from February 2017 through July 2018 from 47 clinical sites in 24 health zones in Kinshasa within an approximate 154 square mile (400 km²) area. Participants (primarily adults) received a rapid HIV test at one of 35 hospitals or clinics in 2017 during the pilot phase, and 47 similar sites (12 additional) in 2018. The sites were in different urban health zones and represented a range of available levels of healthcare delivery. Patient’s blood was drawn in an EDTA tube at the collection sites, centrifuged to prepare plasma, and transferred to ice within 2 h to our laboratory at Université Protestante au Congo (UPC). Plasma specimens were tested by HIV serology and confirmed following the National and WHO recommended algorithm at the sites. Multiple rapid tests were used as follows (Determine HIV-1/2 [Determine; Alere, USA], Uni-Gold HIV [Uni-Gold; Trinity Biotech, Ireland], and Vikia HIV 1/2 [Vikia; bioMérieux, France]). All rapid tests have > 99–100% sensitivity and specificity for the detection of HIV-1 and HIV-2.

To facilitate the privacy and safety of participants, data collection took place in study-specific facilities. During the study visit, interviewers administered a structured questionnaire including modules on demographics, gender and sexual identity, mental health, alcohol and substance use, sexual risk practices, and experiences of stigma. Interviews were conducted in English, French, or another local language (per participant choice) by trained peer or LGBT-friendly interviewers who were fluent in the languages used. Rapid HIV tests were conducted by trained staff following survey administration. HIV testing and counseling were done according to national guidelines in each country, including pre-test counseling and optional, but encouraged, post-test counseling. A serial rapid HIV testing algorithm was implemented using Determine HIV-1/2 (Alere, Japan) for screening and Uni-Gold HIV (Trinity Biotech Ireland) for confirmation of positive screening test results [20 (link)]. All participants who tested HIV-positive were referred for HIV care.

HIV screening was performed using the rapid test Determine HIV-1/2^® (Alere, Matsuhidai Matsudo Shi Chiba, Japan). HIV positivity confirmation was performed using a second rapid test, HIV-1/2 STAT-PAK^® (Chembio, Medford, NY).
All first and second sputum samples were microscopically examined after auramine staining, and all first sputum samples were systematically put in mycobacterial culture, irrespective of patient’s clinical and radiological data. A culture was also performed on the second sputum sample for participants who met at least one of the following criteria: (i) current cough lasting more than two weeks, (ii) abnormal chest X-ray images, (iii) HIV seropositivity, and/or (iv) positive microscopy of the first sputum sample.
Mycobacterial cultures were systematically performed on Lowenstein-Jensen (LJ) solid medium (Biorad, Marnes-la-Coquette, France) and Bactec MGIT 960 liquid medicum (Becton Dickinson Microbiology System, Sparks, NV, USA) [11 ,12 ]. Mycobacterial isolates were tested for drug susceptibility using Bactec MGIT 960 SIRE Kit (Becton Dickinson, Franklin Lakes, New Jersey, USA) [12 ]. The drugs tested were isoniazid, rifampicin, ethambutol and streptomycin.
The interpretation of chest X-rays was performed by two independent experiment readers.

Following the survey, consenting participants received HIV counseling and testing according to the PNG national algorithm of Determine HIV-1/2 (Alere, Hannover, Germany) with confirmation by Stat-Pak HIV-1/2 (Chembio, New York, NY USA). Individuals testing HIV-positive were also provided testing for CD4 T-cell count using PIMA and HIV viral load using the GeneXpert HIV-1 viral load assay (Cepheid, Sunnyvale, CA). Further details on biological testing were previously published [12 (link)].
All participants testing HIV-positive were actively linked to HIV treatment services by a peer navigator. Study staff were trained to identify sexually exploited girls younger than 18 years and refer them to partner organizations experienced in providing psychosocial and protective services to this population.

Health workers in each registration centre formed a recruitment team and attended a three-day training course about the survey protocol. They subsequently collected data on each consenting smear-positive tuberculosis patient, including the patient’s age, sex, level of education, occupation, marital status and HIV status – if known – and details of any previous tuberculosis treatment. After each patient was asked if they had received tuberculosis treatment, the patient’s medical records at the health facility of recruitment were checked for evidence of such treatment.
Following national policy in Malawi,⁸ each participant in the survey was offered HIV testing and counselling. At the time of the survey, two rapid blood tests – Uni-Gold Recombigen HIV-1/2 (Trinity Biotech, Bray, Ireland) and Determine HIV-1/2 (Alere, Waltham, United States of America) were used in the registration centres. Any samples giving inconclusive results were sent to the Central Reference Laboratory for retesting.
Data were collected on piloted forms and double-entered into an Epi Info (Centers for Disease Control and Prevention, Atlanta, United States of America) spreadsheet.

For each donor, 10 ml of whole blood were collected in a dry tube. After centrifugation at 3000 rpm for 5 min, serum was collected for the detection of viral and bacterial infections as depicted in Figure 1. A rapid diagnostic test (RDT) (Alere Determine™ HIV-1/2) was used for the qualitative detection of anti-HIV-1/2 antibodies, whereas an enzyme-linked immunosorbent assay (ELISA Genscreen™ ULTRA HIV Ag-Ab) was employed to detect the viral antigens in the plasma of donors. For HBV, two tests were also used; a RDT-based assay (One Step HBsAg Rapid Test) for the qualitative detection of HBV surface antigen (HBsAg), and an ELISA test (HBsAg Biorex®) for quanlitative detection of HBsAg. An ELISA test (Biorex 4^th Generation® Anti-HCV) was also used for the detection of anti-HCV antibodies in the plasma and the T. pallidum hemagglutination (TPHA) test (Biolabo®) was used for the qualitative and semi-quantitative detection of anti-T. pallidum antibodies.