Amplicor hiv 1 monitor test

Manufactured by Roche

Sourced in United States, Switzerland

The Amplicor HIV-1 Monitor Test is a laboratory equipment product designed for the quantitative detection of HIV-1 RNA in human plasma or serum samples. It utilizes the polymerase chain reaction (PCR) method to amplify and detect the HIV-1 genetic material.

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Spelling variants of this product

Cobas Amplicor HIV-1 Monitor Test (17 citations) Cobas Amplicor HIV-1 Monitor Test, version 1.5 (16 citations) Amplicor HIV-1 Monitor (11 citations) Amplicor HIV-1 Monitor test version 1.5 (11 citations) COBAS AMPLICOR HIV-1 Monitor Test v1.5 (9 citations) Amplicor HIV Monitor Test (7 citations) Amplicor HIV-1 Monitor Test V1.5 (7 citations) AMPLICOR HIV-1 monitor test kit, version 1.5 (2 citations) COBAS Amplicor HIV-1 Monitor Test kit (2 citations) Amplicor HIV-1 monitor ultrasensitive test (2 citations)

46 protocols using amplicor hiv 1 monitor test

Demographic and Clinical Characteristics of HIV Patients

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We collected demographic data (age, gender), risk factors for HIV acquisition, duration of HIV, CD4⁺ cell counts, HIV viral load, and the history of antiretroviral therapy (ART) from the hospital database. The CD4⁺ cell counts and HIV viral loads were considered relevant if the blood sample for their determination was taken within 1 month before or after EGD. Histopathological data were collected from the database of the Institute of Pathology, Faculty of Medicine, University of Belgrade.
The HIV status was determined using commercial immunoassays, in accordance with the manufacturer´s protocol. The CD4 cells were quantified by flow cytometry (Becton Dickinson BD FACS Count). Plasma HIV-1 RNA loads were measured with EDTA collected plasma samples, frozen at -20°C, using commercial RT-PCR tests. The usage of PCR tests and their limits of detection, expressed as copies per milliliter (cps/ml), varies over time according to what was available on the market. From 1997 to 2008 Roche Amplicor HIV-1 Monitor Test was used, with the range of detection of 400 cps/ ml– 750000 cps/ml, while from 2008 to 2016 COBAS AmpliPrep/CobasTaqMan HIV version 1.5, with the range of detection from 48 cps/ml– 10 000 000 cps/ml was used, and recently, in 2016, COBAS HIV-1 4800/6800/8800 with the range of detection from 20 cps/ml– 10 000 000 cps/ml of plasma was introduced.

Spurnic A.R., Bukumiric Z., Jevtovic D., Brmbolic B., Pekmezovic T., Salemovic D., Pesic Pavlovic I., Milosevic I., Ranin J, & Korac M. (2021). Helicobacter pylori infection rates in dyspeptic Serbian HIV-infected patients compared to HIV-negative controls. PLoS ONE, 16(3), e0248041.

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Plasma HIV RNA Measurement Protocols

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Plasma HIV RNA was measured using either the Roche Amplicor HIV-1 Monitor Test version 1.5 or the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test version 2.0 (Roche Diagnostics). Lower limits of detection were 50 and 20 copies/mL, respectively.

Kroon E., Chottanapund S., Buranapraditkun S., Sacdalan C., Colby D.J., Chomchey N., Prueksakaew P., Pinyakorn S., Trichavaroj R., Vasan S., Manasnayakorn S., Reilly C., Helgeson E., Anderson J., David C., Zulk J., de Souza M., Tovanabutra S., Schuetz A., Robb M.L., Douek D.C., Phanuphak N., Haase A., Ananworanich J, & Schacker T.W. (2022). Paradoxically Greater Persistence of HIV RNA-Positive Cells in Lymphoid Tissue When ART Is Initiated in the Earliest Stage of Infection. The Journal of Infectious Diseases, 225(12), 2167-2175.

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Tanzanian HIV Prevalence and Factors

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Before the survey and blood draw, informed consent was obtained from all study participants. The survey assessed demographic, behavioral, and sociostructural factors such as stigma, social cohesion and gender-based violence (GBV) experience, as well as exposure to and use of HIV programs and services. All consenting participants (including those self-reporting to be HIV positive) were counseled and tested for HIV following Tanzanian national guidelines, using a dual parallel algorithm of the Uni-Gold and Determine rapid HIV-1 antibody tests in the field at the time of the survey, followed by a repeat dual parallel algorithm of these same tests after 2 weeks in the case of discordant results. VL analyses from specimens of all HIV-infected women were performed at the Muhimbili University of Health and Allied Sciences (MUHAS) laboratory in Dar es Salaam, using polymerase chain reaction technology with the Roche Amplicor HIV-1 Monitor Test. The study was approved by the Institutional Review Boards of the Johns Hopkins Bloomberg School of Public Health, and MUHAS and the National Institute of Medical Research (NIMR) in Tanzania. Participants were compensated 5000 Tanzanian shillings (Tsh) (US $2.50) for the baseline visit.

Kerrigan D., Mbwambo J., Likindikoki S., Beckham S., Mwampashi A., Shembilu C., Mantsios A., Leddy A., Davis W, & Galai N. (2016). Project Shikamana: Baseline Findings From a Community Empowerment–Based Combination HIV Prevention Trial Among Female Sex Workers in Iringa, Tanzania. Journal of Acquired Immune Deficiency Syndromes (1999), 74(Suppl 1), S60-S68.

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Validated Immunophenotyping Assay for HIV

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We are a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited laboratory. The peripheral CD4 and CD8 T cell counts for the study subjects were performed using our clinically validated flow-cytometry based immunophenotyping assay that utilizes the BD Multitest^TM 6 color TBNK Reagent with Trucount^TM tubes (BD Biosciences, San Jose, CA) (Supplementary Data). From 1999 to November 2008, viral load quantification was performed using the Roche Amplicor HIV-1 Monitor test (Roche Molecular Systems, Inc., Branchburg, NJ). After November 2008, the Abbott Real Time HIV-1 assay (Abbott Molecular Inc., Des Plaines, IL) was deployed to measure the viral load (Supplementary Data). For the purpose of this study a cut-off value of >200 HIV-RNA copies/ml of plasma was used to define a detectable viral load.

Khanolkar A., Muller W.J., Simpson B.M., Cerullo J., Williams R., Sowers S.B., Matthews K., Mercader S., Hickman C.J., D’Aquila R.T, & Liu G. (2022). Preservation of lymphocyte functional fitness in perinatally-infected and treated HIV+ pediatric patients displaying sub-optimal viral control. Communications Medicine, 2, 25.

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Characterization of HIV-1 Viral Load

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We are a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited laboratory. The peripheral CD4 and CD8 T cell counts for the study subjects were performed using our clinically validated flow-cytometry based immunophenotyping assay that utilizes the BD Multitest™ 6 color TBNK Reagent with Trucount™ tubes (BD Biosciences, San Jose, CA) (Supplementary Data). From 1999 to November 2008, viral load quantification was performed using the Roche Amplicor HIV-1 Monitor test (Roche Molecular Systems, Inc., Branchburg, NJ). After November 2008, the Abbott Real Time HIV-1 assay (Abbott Molecular Inc., Des Plaines, IL) was deployed to measure the viral load (Supplementary Data). For the purpose of this study a cut-off value of >200 HIV-RNA copies/ml of plasma was used to define a detectable viral load.

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Comparative Evaluation of Dried Blood Spot Viral Load Testing

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Studies were included if they included technical evaluation data comparing dried blood spot samples to plasma, were pertaining to viral load testing, and were performed using HIV–positive blood. Studies were excluded if they used spike blood samples or panels, compared dried blood spot samples to plasma with a different assay, performed a qualitative analysis of dried blood spot samples, or the comparator was a sample type other than plasma. Sixty studies were identified through online searches and expert notification (Fig 1). We contacted the corresponding authors of all studies that met the inclusion criteria to explain the analysis plan and request original data and obtained original data from 4 studies that were not yet published. For the meta-analysis, a total of 40 studies provided 45 data sets across the 6 technologies resulting in a total of 10,831 paired dried blood spot and plasma viral load results. Correction factors were applied as suggested by the manufacturers for the Hologic Aptima and Roche COBAS TaqMan FVE technologies. Due to the discontinuation of the Roche Amplicor HIV-1 Monitor test, v1.5, data using this technology were excluded from the analysis. Study characteristics were extracted from each manuscript or through author contact.

Vojnov L., Carmona S., Zeh C., Markby J., Boeras D., Prescott M.R., Mayne A.L., Sawadogo S., Adje-Toure C., Zhang G., Perez Gonzalez M., Stevens W.S., Doherty M., Yang C., Alexander H., Peter T.F, & Nkengasong J. (2022). The performance of using dried blood spot specimens for HIV-1 viral load testing: A systematic review and meta-analysis. PLoS Medicine, 19(8), e1004076.

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HIV-Exposed Infant Outcomes by Maternal ARV Use

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We analyzed data collected prospectively at the Instituto de Puericultura e Pediatria Martagao Gesteira at Universidade Federal do Rio de Janeiro (UFRJ), a tertiary care pediatric hospital in Rio de Janeiro City, with a pediatric HIV clinic that cares for more than 1,000 HEU infants and more than 400 HIV-infected children. HIV-infected mothers are counselled not to breastfeed; replacement feeding is provided free of charge in the first 12months. HIV-exposed infants receive zidovudine until six weeks of life, and afterwards cotrimoxazole prophylaxis until the infant has had two undetectable viral load measurements. For this analysis, one undetectable viral load measurement at least 6 weeks after birth was required to exclude HIV infection. The Roche Amplicor HIV-1 Monitor Test was used to determine viral load, with a detection limit of 400 copies/mL.
Women were classified as having received no ARVs, zidovudine monotherapy, dual therapy or cART during pregnancy. If a woman changed regimens, the regimen with the larger number of drugs was used in the analysis. If she switched between non-nucleoside reverse transcriptase inhibitor (NNRTI)-based cART and protease inhibitor (PI)-based cART, the regimen received for longer was used in the analysis.

Hofer C.B., Keiser O., Zwahlen M., Lustosa C.S., CisneFrota A.C., de Oliveira R.H., Abreu T.F., Carvalho A.W., Araujo L.E, & Egger M. (2016). In Utero Exposure to Antiretroviral Drugs: Effect on Birth Weight and Growth Among HIV-Exposed Uninfected Children in Brazil. The Pediatric infectious disease journal, 35(1), 71-77.

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Newly Diagnosed HIV-1 Patients in Nanjing

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Patients who had been newly diagnosed with HIV-1 infection within Nanjing's districts of Qinhuai, Xuanwu, Qixia, Jiangning, and Gulou have been enrolled in the study during 2015–2019. The inclusion criteria for samples selection were as follows: (1) HIV enzyme-linked immunosorbent assay was positive and confirmed via HIV-1 Western blot test as well; (2) newly diagnosed without cART; and (3) obtaining the participant's informed consent in oral or written forms. We collected 10 ml of peripheral blood from each patient using an ethylenediaminetetraacetic acid (EDTA) anticoagulation tube and separated the plasma within 12 h. According to the instructions of BD Multitest CD3/CD8/CD45/CD4 (FITC/PE/PerCP/APC), the CD4⁺ T-cell count of HIV-1-infected patients was measured by flow cytometry (FACSCalibur, Becton and Dickinson Company, USA). The plasma HIV-1 viral load was quantified by the AMPLICOR HIV-1 MONITOR TEST (Roche, Basle, Switzerland).

Ge Y., Liu Y., Fu G., Lu J., Li X., Du G., Fei G., Wang Z., Li H., Li W, & Wei P. (2022). The Molecular Epidemiological and Immunological Characteristics of HIV-1 CRF01_AE/B Recombinants in Nanjing, China. Frontiers in Microbiology, 13, 936502.

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Darunavir-Resistant HIV-1 Protocol

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Adult HIV-1-infected, treatment-naïve or treatment-experienced (on a stable antiretroviral regimen for ≥12 weeks prior to screening) patients with no darunavir RAMs were recruited. Patients were required to have plasma VL ≥1000 HIV-1 RNA copies/ml (Amplicor HIV-1 Monitor Test, version 1.5, Roche Diagnostics, Basel, Switzerland) at screening, eGFR_CG ≥80 ml/min, genotypic sensitivity to the two investigator-selected N[t]RTIs (GenoSure MG™ assay, Monogram Biosciences, South San Francisco, CA, USA), and none of the following darunavir RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V or L89V [40 (link)]. Exclusion criteria included previous or current use of darunavir, a newly diagnosed AIDS-defining condition, proven or suspected acute hepatitis or treatment for hepatitis C, and females who were pregnant or breastfeeding.
Prior to study start, the trial protocol was reviewed and approved by an independent ethics committee or an institutional review board at each study site. The trial was conducted according to the International Conference on Harmonization guideline for Good Clinical Practice and principles of Good Clinical Practice and Declaration of Helsinki. All patients provided written informed consent.

Tashima K., Crofoot G., Tomaka F.L., Kakuda T.N., Brochot A., Van de Casteele T., Opsomer M., Garner W., Margot N., Custodio J.M., Fordyce M.W, & Szwarcberg J. (2014). Cobicistat-boosted darunavir in HIV-1-infected adults: week 48 results of a Phase IIIb, open-label single-arm trial. AIDS Research and Therapy, 11, 39.

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Early HIV Viral Load Measurement

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Early set point viral load (VL) for newly infected individuals was defined as the earliest stable nadir VL value measured between 3 and 9 months post infection and which did not show a significant increase in value within a 3–4 month window. HIV plasma VL was determined at the Emory Center for AIDS Research Virology Core Laboratory using the Amplicor HIV-1 Monitor Test (version 1.5; Roche). CD4+ T cell counts were based on T-cell immunophenotyping, with assays done using the FACScount System (Beckman Coulter Ltd., London, United Kingdom) in collaboration with the International AIDS Vaccine Initiative.

Claiborne D.T., Scully E.P., Palmer C.D., Prince J.L., Macharia G.N., Kopycinski J., Michelo C.M., Wiener H.W., Parker R., Nganou-Makamdop K., Douek D., Altfeld M., Gilmour J., Price M.A., Tang J., Kilembe W., Allen S.A, & Hunter E. (2019). Protective HLA alleles are associated with reduced LPS levels in acute HIV infection with implications for immune activation and pathogenesis. PLoS Pathogens, 15(8), e1007981.

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