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Uni gold hiv test

Manufactured by Trinity Biotech
Sourced in Ireland

The Uni-Gold HIV test is a rapid diagnostic test used to detect the presence of antibodies to the human immunodeficiency virus (HIV) in human blood, serum, or plasma samples. It provides a qualitative result, indicating whether the sample is reactive or non-reactive for HIV antibodies.

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7 protocols using uni gold hiv test

1

Rapid HIV Testing Algorithms in Uganda

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HIV status was determined by rapid HIV tests performed in the community by certified laboratory technologists, and enzyme linked immunoassay (EIA) with RNA PCR confirmation was done in the laboratory at the Uganda Virus Research Institute, Entebbe. Rapid diagnostic testing of HIV was performed according to the Uganda national testing algorithm. Blood samples were first tested with Alere Determine® HIV-1/2 test (Alere Medical Co., Ltd., Chiba, Japan), and if non-reactive, results were reported as negative. Reactive samples were then tested with the HIV 1/2 STAT-PAK® assay (Chembio Diagnostic Systems, Inc. Medford, NY, USA), and if reactive, results were reported as positive. If results were discordant on STAT-PAK®, Uni-Gold HIV test (Trinity Biotech plc, Bray, Ireland) was used as a tie-breaker. All samples positive on rapid tests were re-tested in duplicate using the Vironostika HIV Ag/Ab (Biomerieux, SA, Marcy-l’Etoile, France) EIA. Discordant EIA results were confirmed using HIV RNA PCR (COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0, Roche Molecular Diagnostics, Pleasanton, CA, USA).
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2

HIV Rapid Test Evaluation in Africa

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Samples were initially tested in-country at local laboratories using two HIV rapid tests performed in parallel on fresh samples. The following rapid tests were used for this initial assessment: Determine HIV-1/2 (Inverness Medical Innovations, Phetchabun, Japan), SD Bioline HIV 1/2 v3 (Youngin-Si, South Korea), or Uni-Gold HIV Test (Trinity Biotech, Bray, Ireland; Soweto only). Samples with discordant rapid test results were analyzed in-country using a tie-breaker test. The site in Tanzania used a third HIV rapid test as the tie-breaker test (Uni-Gold HIV Test). The two sites in South Africa used a fourth-generation chemiluminescent immunoassay (CMIA) as the tie-breaker test (the ARCHITECT HIV Ag/Ab Combo assay, Abbott Laboratories, Wiesbaden, Germany; referred to below as the Abbott Combo assay). All other testing described in this report was performed at the HPTN Laboratory Center.
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3

Rapid HIV Testing in Clinic Settings

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Couples were invited for venopuncture after CHCT. Blood spots samples for each participant were drawn from the vein by trained counsellors who were mainly registered nurses/midwives. Then blood spots were tested in the clinics’ laboratories simultaneously using two tests, the Determine® HIV/2 test (Abbott Diagnostic Division, Hoofddorp, The Netherlands) and the Uni-Gold HIV test® (Trinity Biotech®, Dublin, Ireland). Samples with indeterminate or discordant results between the two rapid tests w confirmed with enzyme-linked immunosorbent assay (ELISA) at the Department of Clinical Laboratory at the KCMC.
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4

National HIV Continuum of Care Survey

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Survey staff administered the household and the adult questionnaires during a face-to-face interview with participants using Google Nexus 9 tablets. The household questionnaire collected data on household assets and access to food. The adult questionnaire included questions on lifetime and recent sexual behaviors, as well as questions on the HIV continuum of care for those who reported being HIV positive. Only one female participant aged 15 years or older in each household was randomly selected to answer questions about experiences with sexual violence, to mask the nature of the questions to other members of the household. Any female younger than 18 who reported being sexually exploited was referred to support services for counseling and further management.
Rapid HIV testing was conducted using point-of-care (POC) tests—Determine HIV-1/2 Rapid Test (Alere)—and confirmed with a Uni-Gold HIV Test (Trinity Biotech), as per the national algorithm. Laboratory verification of all HIV-positive results was done using the Geenius HIV-1/2 Supplemental Assay (Bio-Rad). Viral load testing was done preferentially on plasma, or on dried blood spots (DBSs) if necessary, at a central lab on an automated platform.
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5

HIV Screening and CD4+ Evaluation

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Blood samples were aseptically collected using a disposable sterile safety vacutainer syringe with a needle through venipuncture. Exactly 5 mL of venous blood samples were collected from each patient, put into EDTA bottles and shaked, then centrifuged at 3000 rpm for 10 min to get serum. All the patients were tested for HIV using Determine HIV-1/2 test (Abbott Laboratories, Sittingbourne, UK) and Uni-Gold HIV test (Trinity Biotech, Co.Wicklow, Ireland) kits according to the manufacturer’s instructions. The CD4+ counts of the patients were also evaluated according to the kit manufacturer’s instructions. The patients were interviewed for demographic information such as their age, sex, occupation, marital status and educational qualification.
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6

HIV-1 Serological Confirmation Workflow

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HIV-1 serology was determined by rapid HIV tests performed in the community by certified laboratory technologists and EIA confirmation in the laboratory at Uganda Virus Research Institute. In the rapid HIV testing algorithm blood samples were first tested with Determine HIV assay (Alere Medical Co., Ltd., Chiba, Japan), and if negative, results were reported as negative. Determine positive samples were then tested with HIV 1/2 Stat-Pak assay (Chembio Diagnostic Systems, Inc. Medford, NY, USA), and if positive too, results were reported as positive. But if negative on Stat-Pak, Uni-Gold HIV test (Trinity Biotech plc, Bray, Ireland) was used as a tie-breaker. All positive rapid results were confirmed using 2 parallel enzymelinked immunosorbent assay (EIA) tests: Vironostika (HIV Uni-Form II plus 0 microelisa system, Biomerieux, SA, Marcy l'Etoile, France); and Murex HIV-1.2.O (Diasorin S.P.A, Dartford, United Kingdom). Concordinant EIA positives were taken as positive but discordant EIA results were comfirmed using HIV RNA PCR (COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0 from Roche Molecular Diagnostics, Pleasanton, CA, USA).
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7

HIV Screening and Diagnosis Protocol

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CHiP participants were initially screened for HIV infection by fingerprick using the Alere Determine HIV-1/2 test (Alere International). Participants with a non-reactive test had no further testing. Participants with reactive results were further tested with the Uni-Gold HIV test (Trinity Biotech). If results were concordant, the participant was referred for care. If results were discordant, the testing was repeated. If the results were still discordant, the CHiPs would return 2 wk later for follow-up testing. If results were discordant again, a venous blood sample was collected and sent to the laboratory for further testing using the rapid tests and, if indicated, testing using the Abbott Architect HIV Ag/Ab Combo Assay. This test algorithm is in keeping with Zambian national guidelines.
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