Unigold

Manufactured by Trinity Biotech

Sourced in Ireland, United States, Japan, China

Unigold is a compact and automated diagnostic instrument designed for rapid and reliable detection of various analytes. It utilizes a proprietary gold nanoparticle-based immunoassay technology to deliver accurate and reproducible results. The core function of Unigold is to provide a versatile platform for point-of-care testing and laboratory applications.

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Spelling variants of this product

Unigold Rapid HIV test (3 citations) Unigold HIV kit (3 citations) Unigold test kit (2 citations) HIV-1/2 Unigold Recombinant Assay (2 citations)

96 protocols using unigold

Routine Opt-Out HIV Testing in Antenatal Care

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At their first antenatal care visit, all pregnant women were offered HIV testing and
counseling (HTC) on an “opt out” basis, meaning all women were tested for HIV unless they
explicitly refused. The HTC was performed by trained providers: nurses or midwives or lay
PMTCT counselors. As per the national guidelines, the HIV testing algorithm is a serial
rapid HIV testing, and the description here refers to the active guidelines at the time of
the study. The first-line test used was Determine; if the Determine test result was
negative, the HIV status was considered negative; when Determine result was positive, the
second-line test, Uni-Gold was used; if Uni-Gold test result, Trinity Biotech was also
positive, the result was considered positive; if Uni-Gold test result was negative
(discordant with Determine test result), a third-line test, Bioline, was used as a tiebreaker.¹³ The retesting of previously tested HIV-negative women was performed by the same
providers and followed the same algorithm as the initial HIV testing.

Mandala J., Kasonde P., Badru T., Dirks R, & Torpey K. (2019). HIV Retesting of HIV-Negative Pregnant Women in the Context of Prevention of Mother-to-Child Transmission of HIV in Primary Health Centers in Rural Zambia: What Did We Learn?. Journal of the International Association of Providers of AIDS Care, 18, 2325958218823530.

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HIV Diagnosis Workflow for Participants

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Venous blood was collected for other tests including HIV status (for participants with unknown HIV status). HIV testing was done using two rapid antibody tests (SD HIV- 1/2 3.0 SD standard diagnostics Inc, and The Uni-Gold, Trinity Biotech, IDA Business Park, Bray, Co. Wicklow, Ireland). Discordant samples were tested using Uniform II vironostika-HIV Ag/Ab Micro-Elisa system (Biomerieuxbv, The Netherlands), and CD4 counts (cells/μL) using CyflowPartec machine (Partec GmbH, Munster, Germany).

Jeremiah K., Filteau S., Faurholt-Jepsen D., Kitilya B., Kavishe B.B., Krogh-Madsen R., Olsen M.F., Changalucha J., Rehman A.M., Range N., Kamwela J., Ramaiya K., Andersen A.B., Friis H., Heimburger D.C, & PrayGod G. (2020). Diabetes prevalence by HbA1c and oral glucose tolerance test among HIV-infected and uninfected Tanzanian adults. PLoS ONE, 15(4), e0230723.

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Comprehensive Metabolic Profiling in Fasted Participants

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Following 8 hours of overnight fasting, plasma glucose (Hemocue201 RT, Hemocue AB, Angelholm, Sweden) and glycated haemoglobin A1c (HbA1c) (Hemocue HbA1c 501, Hemocue AB, Angelholm, Sweden) were determined using venous blood. Then participants underwent an oral glucose tolerance test (OGTT) with blood collection at 30 and 120 minutes (min). Venous blood samples drawn at the same time as those for glucose assessment were separated into serum for insulin (fasting, 30 min and 120 min) and CRP assessments and stored at -80°C pending analysis. ELISA technique was used to assess insulin in Denmark using dual-monoclonal antibodies (ALPCO, Salem, NH, USA) whereas CRP was measured using sandwich ELISA in Germany [24 (link)]. HIV testing was done using two rapid antibody tests (SD HIV- 1/2 3.0 SD standard diagnostics Inc, and The Uni-Gold, Trinity Biotech, IDA Business Park, Bray, Co. Wicklow, Ireland). Discordant samples were tested using Uniform II vironostika-HIV Ag/Ab Micro-Elisa system (Biomerieuxbv, The Netherlands).

PrayGod G., Filteau S., Range N., Ramaiya K., Jeremiah K., Rehman A.M., Krogh-Madsen R., Friis H, & Faurholt-Jepsen D. (2022). The association of Schistosoma and geohelminth infections with β-cell function and insulin resistance among HIV-infected and HIV-uninfected adults: A cross-sectional study in Tanzania. PLoS ONE, 17(1), e0262860.

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HIV Status Assessment and Inflammation Markers

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Participants with unknown HIV status were tested according to the national testing algorithm after counseling and consent. HIV testing was done using two rapid antibody tests (SD HIV‐1/2 3.0 SD standard diagnostics Inc, and The Uni‐Gold, Trinity Biotech, IDA Business Park, Bray, Co. Wicklow, Ireland). HIV status was defined as HIV‐negative, HIV‐infected not on ART and HIV‐infected on ART. Additionally alpha‐1‐acid glycoprotein (AGP) and C‐reactive proteins (CRP) were assessed as markers of systemic inflammation using an in‐house sandwich ELISA at Dr. Juergen G. Erhardt laboratory in Germany [41 (link)].

Kweka B.V., Fredrick C., Kitilya B., Jeremiah K., Lyimo E., Filteau S., Rehman A.M., Friis H., Olsen M.F., Faurholt‐Jepsen D., Krogh‐Madsen R, & PrayGod G. (2022). Association of sickle cell trait with β‐cell dysfunction and physical activity in adults living with and without HIV in Tanzania. Apmis, 130(4), 230-239.

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HIV Antibody Screening Protocol

Cited 1 time

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Plasma samples were screened for antibodies against HIV1/2 following the national serial rapid HIV testing algorithm and the WHO’s guidelines on HIV testing and counseling strategy.20 ,21 (link) Accordingly, three commercially available rapid tests were used in the following order: Wantai (Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., China) (screening test), Uni-Gold^TM (Trinity Biotech PLC, Bray, Ireland) (confirmatory test), and Vikia (bioMérieux SA, France) (tiebreaker test). According to the HIV testing algorithm, to declare a person HIV positive, he/she should be positive with at least two tests. The sensitivity and specificity of each rapid test are summarized in the

Supplementary Table 1

.
Briefly, plasma samples that tested positive with the first test (Wantai) were subjected to the second test (Uni-Gold), and those found positive with the second test too considered positive for HIV1/2 antibodies. Likewise, those samples positive with the first test and negative with the second test (discordant result) were tested with the third test (Vikia), and samples that turned positive were considered positive for HIV1/2 antibodies. Results from each test were interpreted as per the manufacturer’s instruction.

Tassachew Y., Abebe T., Belyhun Y., Teffera T., Shewaye A.B., Desalegn H., Andualem H., Kinfu A., Mulu A., Mihret A., Howe R, & Aseffa A. (2022). Prevalence of HIV and Its Co-Infection with Hepatitis B/C Virus Among Chronic Liver Disease Patients in Ethiopia. Hepatic Medicine : Evidence and Research, 14, 67-77.

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HIV Testing Procedure and Referral

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HIV testing was done using KHB (Shanghi Kehua Bio-engineering, Ltd, Shanghai, China) as a screening test, HIV1/2 STAT-PAK^® ASSAY (CHEMBIO Diagnostic systems, Inc., Medford, NY, USA) as a confirmatory test, and Uni-Gold TM (Trinity Biotech, Jamestown, NY, USA) as a tie-breaker according to the national algorithm (18 ). HIV testing was done after counseling, and patients with HIV infection were referred to HIV care and treatment clinics after post test counselling.

Belay M., Bjune G, & Abebe F. (2015). Prevalence of tuberculosis, HIV, and TB-HIV co-infection among pulmonary tuberculosis suspects in a predominantly pastoralist area, northeast Ethiopia. Global Health Action, 8, 10.3402/gha.v8.27949.

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Serological Profiling of HIV, HBV, and HCV

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The HIV-positive patients' medical and laboratory records were reviewed to obtain demographic data (age and sex), hepatitis B surface antigen (HBsAg), antibodies to HCV (anti-HCV), and CD4 T-lymphocyte count test results. Serological tests had been performed to determine HIV, HBsAg and anti-HCV status at baseline. HIV screening was done using Alere Determine^TM HIV ½ (Abbott, USA) and Uni-goldTM (Trinity Biotech Plc, Ireland) as a counter-check when positive HIV results were obtained. Confirmation was with Western blot testing (Bio-rad Laboratories Inc, USA). CD4 T-lymphocyte count was determined with Cyflow® counter (Sysmex Partec, Germany). As per the national HIV guidelines¹⁸, all confirmed HIV positive individuals had their HBV and HCV status determined using hepatitis B surface antigen enzyme linked immunosorbent assay (ELISA) (Bio-rad Laboratories Inc., USA) and anti-HCV ELISA (Bio-rad Laboratories Inc., USA) respectively. These methods were consistently used throughout the study period.
Nucleic acid testing for HBV DNA and HCV RNA to confirm positive serological HBsAg and anti-HCV test results respectively were not available in our laboratory at the time of analyses.

Nnakenyi I.D., Uchechukwu C, & Nto-ezimah U. (2020). Prevalence of hepatitis B and C virus co-infection in HIV positive patients attending a health institution in southeast Nigeria. African Health Sciences, 20(2), 579-586.

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HIV Screening and Enrollment Protocol

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At the study site, staff described the study, and individuals who were interested were asked if they were aware of their HIV status; those who said they were HIV seropositive were excluded. The remaining men underwent risk reduction counselling and were tested for HIV using the Alere Determine^TM HIV1-2 rapid test (Alere, USA) on finger prick blood samples; those with a positive result were retested using Uni-gold^TM (Trinity Biotech, Ireland). Discordant results were resolved by using an HIV-1 p24Ag ELISA test (HIV Combi PT, Roche Switzerland) on a venous blood sample; the test was performed at Lancet Laboratories, Rustenburg. Men who were HIV seropositive on both rapid tests or by ELISA were referred for care and were not eligible for screening and enrolment. The remaining men were invited to participate in the study and provided signed informed consent in the language of their choice (English, Setswana or Xhosa).

Maenetje P., Lindan C., Makkan H., Chetty-Makkan C.M., Latka M.H., Charalambous S., Mlotshwa M., Malefo M., Brumskine W., Hills N.K., Price M.A, & Edward V. (2019). HIV incidence and predictors of inconsistent condom use among adult men enrolled into an HIV vaccine preparedness study, Rustenburg, South Africa. PLoS ONE, 14(4), e0214786.

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Sexual Behaviors and Health Outcomes among MSM

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The questionnaire contained sections covering demographic data and several items related to MSM's sexual experience, and physical and mental health. The current analysis focused on sexual risk behaviors, including sexual identities and orientations, numbers of sexual partners, condom use, and lubricant use (Table I). Sexual motivations were recorded by asking the question “What are you most often looking for when you want to have sex with men [in general]?” Response categories included sexual gratification, love/affection, companionship, money, and other. In this report, money-motivated MSM refers to those participants who responded with money to this question, and affection-motivated MSM refers to those participants who responded with love/affection. HIV-1 status was tested by two rapid tests, Determine, Abbott Laboratories, USA; Unigold, Trinity Biotech plc, Ireland.

Bui T.C., Nyoni J.E., Ross M.W., Mbwambo J., Markham C.M, & McCurdy S.A. (2014). Sexual motivation, sexual transactions and sexual risk behaviors in men who have sex with men in Dar es Salaam, Tanzania. AIDS and behavior, 18(12), 2432-2441.

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HIV Treatment Protocols in Tanzania

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HIV status was determined by SD Bioline (Standard Diagnostics) and if positive confirmed by Unigold (Trinity Biotech). For HIV+ children, CD4 counts were quantified by flow cytometry using either BD Facs Canto™ II (BD) or Facs Calibur™ (BD). HIV plasma viral loads were quantified by Xpert HIV-1 Viral Load kit (Cepheid). Information on ART was obtained by interviewing guardians of HIV+ volunteers and from the hospital database. As per the current Tanzanian national guidelines (The United Republic of Tanzania, 2019 ), preferred first line ART regimen for children’s with <20kg is a protease inhibitor (PI)-based regimen containing lopinavir and ritonavir (LPV/r) with nucleoside reverse transcriptase inhibitors (NRTI) combinations: abacavir and lamivudine (ABC/3TC). Integrase inhibitor, dolutegravir (DTG)-based regimen in combination with ABC and 3TC is recommended as the preferred 1^st line for children living with HIV weighing ≥20kg. Previously (The United Republic of Tanzania, 2017 ), the following drug combinations were recommended as 1^st line treatment for children:

Mbuya W., Mwakyula I., Olomi W., Agrea P., Nicoli F., Ngatunga C., Mujwahuzi L., Mwanyika P, & Chachage M. (2021). Altered Lipid Profiles and Vaccine Induced-Humoral Responses in Children Living With HIV on Antiretroviral Therapy in Tanzania. Frontiers in Cellular and Infection Microbiology, 11, 721747.

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