In accordance with national guidelines, HIV Home-Based Testing and Counselling was conducted in each household. Participants with a non-reactive result on the screening test (Alere Determine™ HIV-1/2 (Abbott Laboratories, Lake Bluff, IL)) were reported as HIV-negative, while those with a reactive screening test result underwent confirmatory testing using Uni-Gold™ HIV-1/2 (Trinity Biotech, Wicklow, Ireland). Those with a reactive screening and confirmatory test were classified as HIV positive. Those that were reactive by Alere Determine™ and non-reactive by UniGold™ HIV-1/2 were asked to return to their preferred health facility for additional testing in 4 weeks. HIV-seropositive participants were referred to HIV care and treatment at a health facility of their choice. For participants under age 17 years, results were provided to a parent or guardian.
Uni gold hiv 1 2
Manufactured by Trinity Biotech
Sourced in Ireland, Japan
The Uni-Gold HIV-1/2 is a rapid diagnostic test kit designed for the qualitative detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in human serum, plasma, or whole blood samples.
Automatically generated - may contain errors
Lab products found in correlation
Determine hiv 1 2, by Abbott (6 mentions)
Vikia hiv 1 2, by bioMérieux (2 mentions)
Genscreen ultra hiv ag ab, by Bio-Rad (2 mentions)
Alere determine hiv 1 2, by Abbott (2 mentions)
Determine hiv 1 2 ag ab, by Abbott (1 mentions)
Geenius hiv 1 2 supplemental assay, by Bio-Rad (1 mentions)
Enzygnost hiv integral 4 elisa, by Siemens (1 mentions)
Murex hiv ag ab combination, by DiaSorin (1 mentions)
Sd bioline hiv 1 2, by Standard Diagnostics (1 mentions)
Serodia tp pa, by Fujirebio (1 mentions)
Enzygnost hiv integral 2 antibody antigen elisa, by Siemens (1 mentions)
Sd bioline hiv 1 2 3.0 rapid test, by Standard Diagnostics (1 mentions)
Determine hiv 1 2, by Trinity Biotech (1 mentions)
Sd bioline syphilis 3, by Standard Diagnostics (1 mentions)
21 protocols using uni gold hiv 1 2
1
HIV Home-Based Testing and Counseling
2
HIV Screening and Behavioral Assessment
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At every visit, HIV testing was performed using determine HIV-1/2 (Abbott Diagnostics, UK) for screening and a reactive result was confirmed by Stat-Pak dipstick HIV-1/2 (Chembio Diagnostics, US). The Uni-Gold HIV-1/2 (Trinity Biotech, Ireland) was used as a tie breaker if Determine and Stat-Pak were discordant. At every visit, trained nurse-counsellors administered structured questionnaires to collect data on socio-demographic characteristics, sexual behaviour, reproductive health, alcohol use, and illicit drug use.
3
HIV Screening, Diagnosis, and Monitoring
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All mothers not already known to be HIV-infected were screened for HIV infection as part of antenatal care using a finger prick rapid antibody test (rapid test) (BIOLINE HIV-1/2 3.0 test kit, Standard Diagnostics Inc., Suwon-si, Korea). For confirmation of a positive screening test, a different rapid test was used (Uni-Gold HIV-1/2, Trinity Biotech, Bray, Ireland) [4 ]. In children, MTCT was diagnosed by HIV DNA polymerase chain reaction (PCR) and rapid tests. According to Tanzanian guidelines, all HEIs should have a HIV DNA PCR test at 4–6 weeks of age, a repeat test 6 weeks after cessation of breastfeeding, or at any time of symptoms [4 ]. Passively transferred antibodies from mother-to-child diminish rapidly between 9–18 months of age. Therefore, the type of recommended repeat test depends on the age of the child: an HIV DNA PCR test is used under 9 months, and a rapid test after the 9 months. A rapid test is recommended at 18 months to confirm HIV negative status. HIV DNA PCR analysis is not performed at our hospital but dried blood spot (DBS) samples from a finger, heel or big toe prick are transported to the Kilimanjaro Christian Medical Centre Clinical Laboratory for analysis. The average turnaround time is around two weeks.
4
Hemoglobin and HIV Screening Protocol
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Hemoglobin was performed using the ACT5 DIFF hematology analyser (Beckman Coulter, Miami, Florida). HIV infection was determined according to the National HIV screening algorithm, serial testing by Determine HIV-1/2 (Inverness Medical Japan Co. Ltd, Japan) then Uni-Gold HIV-1/2 (Trinity Biotech, Wicklow, Ireland). Discordant HIV test results were subjected Enzyme Linked Immunosorbent Assay (ELISA).
5
Serological Markers for Viral Hepatitis and HIV
6
HIV Infection Screening Protocol
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Phlebotomy was performed to confirm HIV infection and determine the CD4 count. Subjects were required to have two positive rapid HIV tests: Determine HIV-1/2 Ag/Ab (Alere, Chiba, Japan) and Uni Gold HIV-1/2 (Trinity Biotech, Bray, Ireland). Women who tested positive and were unaware of their current HIV status were provided ELISA results, CD4 results, appropriate counseling, referred to a Ministry of Health Care and Treatment Center (CTC) if not already under care and then entered in the study. Subjects with a discordant ELISA result (one positive, one negative) were not eligible and referred to a CTC for further testing.
7
Household-Based HIV Testing Protocol
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EPHIA staff used a questionnaire prepared for the survey to collect data about
household and individual characteristics. Initial household-based HIV testing
was performed with the national HIV-testing algorithm using three HIV rapid
tests. Individuals with a reactive screening test underwent confirmatory testing
using the Uni-Gold HIV-1/2 (Trinity Biotech, Bray, Ireland). Individuals with
discordant results were administered a tiebreaker test (Vikia HIV-1/2,
bioMérieux, Marcy-l’Étoile, France). All HIV-positive individuals identified in
the field received confirmatory testing in a satellite laboratory using the
Geenius HIV 1/2 Supplemental Assay (Bio-Rad, Hercules, CA USA) [4 ]. Both the questionnaire
and field laboratory data were collected on mobile tablet devices using the
application Open Data Kit, an open-source mobile data collection application.
The Global Positioning System was used to identify and record the geographical
coordinates of each EPHIA sample location. Cluster geolocation data were loaded
onto encrypted and passcode-protected tablet computers in keyhole markup
language format using the MAPS.ME mobile app (https://maps.me ), which includes OpenStreetMap (https://www.openstreetmap.org ) data
[25 ] .
household and individual characteristics. Initial household-based HIV testing
was performed with the national HIV-testing algorithm using three HIV rapid
tests. Individuals with a reactive screening test underwent confirmatory testing
using the Uni-Gold HIV-1/2 (Trinity Biotech, Bray, Ireland). Individuals with
discordant results were administered a tiebreaker test (Vikia HIV-1/2,
bioMérieux, Marcy-l’Étoile, France). All HIV-positive individuals identified in
the field received confirmatory testing in a satellite laboratory using the
Geenius HIV 1/2 Supplemental Assay (Bio-Rad, Hercules, CA USA) [4 ]. Both the questionnaire
and field laboratory data were collected on mobile tablet devices using the
application Open Data Kit, an open-source mobile data collection application.
The Global Positioning System was used to identify and record the geographical
coordinates of each EPHIA sample location. Cluster geolocation data were loaded
onto encrypted and passcode-protected tablet computers in keyhole markup
language format using the MAPS.ME mobile app (
[25 ]
8
Rapid Testing for HIV, HBV, HCV, and Syphilis
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The center employs two different rapid testing procedures for HIV post-donation screening. The rapid test kits employed for HIV detection during the study period were Determine HIV-1/2 (Abbott Laboratories, Illinois, USA) and Uni-Gold HIV-1/2 (Trinity Biotech, Dublin, Ireland). In line with existing national testing algorithm, positive results were re-tested using EIA. ELISA tests were based on AccuDiag™ HIV 1 and 2 Ag/Ab (Diagnostic Automation/Cortez Diagnostic, California, USA). The SD HBsAG ELISA 3.0, SD Standard Diagnostic, Inc., (Republic of Korea) and HCV ELISA 3.0, SD Standard Diagnostic, Inc., (Republic of Korea) were used to test HBsAg and HCV, respectively. Anti-TP was detected using Rapid Cassette Syphilis Ab test, Mediff Biotech. All the kits are approved by the WHO.
9
Whole Blood HIV Diagnosis Protocol
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Whole blood samples were centrifuged at 8,000 rpm for 10–15 min. HIV-1/2 diagnosis was performed using the national serological testing algorithm, which is based on the use of two 3rd-generation rapid diagnostic tests (RDTs), namely, Alere Determine™ HIV-1/2 (Alere Medical Co. Ltd, Japan) and Uni-Gold™ HIV-1/2 (Trinity Biotech, Wicklow, Ireland). Discordant results were retested using the Enzygnost® HIV-1/2 Integral 4 ELISA (Siemens Healthcare Diagnostics Products GmbH, Marburg, Germany).
10
Comprehensive On-Site HIV Testing Protocol
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All venues selected for full PLACE offered on‐site HTS, as part of the bio‐behavioural survey, at a discrete location selected in consultation with KP mobilizers and venue management, typically in a private room or project tent situated in a secluded area. All on‐site HTS was performed using HIV‐1/2 rapid antibody tests according to national guidelines 12 , 42 , and was conducted by trained counsellors who underwent regular proficiency testing for quality assurance purposes. Screening was performed with Determine HIV‐1/2 (Alere, Tokyo, Japan) followed by confirmatory testing with Uni‐gold HIV‐1/2 (Trinity Biotech, Bray, Co. Wicklow, Ireland). In cases of discordant or inconclusive results, repeat testing was done on a new sample: in Malawi, this involved repeat parallel testing and, in Angola, repeat serial testing 12 , 42 .
All bio‐behavioural survey participants provided voluntary informed consent for HTS separately. Study staff actively worked to link all participants with a new HIV diagnosis to care and treatment through phone and in‐person follow‐up and by connecting newly diagnosed individuals to peer health educators, where available. All participants received male condoms; no other reimbursement or incentive was provided.
All bio‐behavioural survey participants provided voluntary informed consent for HTS separately. Study staff actively worked to link all participants with a new HIV diagnosis to care and treatment through phone and in‐person follow‐up and by connecting newly diagnosed individuals to peer health educators, where available. All participants received male condoms; no other reimbursement or incentive was provided.
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