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Cobas taqman hiv 1 test v2

Manufactured by Roche
Sourced in Viet Nam

The COBAS TaqMan HIV-1 test V2.0 is a quantitative in vitro diagnostic test used for the detection of HIV-1 RNA in human plasma. It is intended for use in the management of patients with HIV-1 infection.

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11 protocols using cobas taqman hiv 1 test v2

1

Cytokine and Viral Load Quantification

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Pro-inflammatory and anti-inflammatory cytokines/chemokines and TGFβ isoforms were measured in SP pool by Luminex assays (cytokine human magnetic 25-plex panel; Invitrogen, Courtaboeuf, France and TGFβ 1,2,3 Magnetic Bead Kit, MerckMillipore, Germany). HIV-1 RNA viral load was determined in SP pool by COBAS TaqMan HIV-1 test V2.0 (Roche).
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2

Ultrasensitive HIV RNA Quantification

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HIV RNA in plasma was measured using the Roche Amplicor v 1.5 ultrasensitive assay with a lower quantification limit of 50 copies/mL of plasma (Roche Diagnostics) or by the COBAS TaqMan HIV-1 Test v2.0 (Roche Diagnostics) with a lower measurement limit of 20 copies/mL.
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3

HIV-RNA Quantification Protocol

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Absolute and log transformed VL. HIV-RNA quantification was performed using the COBAS AMPLICOR HIV-1 Monitor Test v1.5 or COBAS Taqman HIV-1 Test v2.0 (Roche Molecular Systems).
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4

Quantitative HIV-1 Viral Load Measurement

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The commercially available kit, Cobas Taqman HIV-1 Test v2.0 (Roche Molecular Systems Inc, Pleasanton, California), was used according to the manufacturer’s instructions.
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5

Quantifying HIV-1 RNA in Plasma

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The presence of HIV-1 RNA in EDTA plasma was quantified with the Cobas TaqMan HIV-1 Test, v2.0 (Roche) according the manufacturer’s instruction. This assay has a lower limit of quantification of 20 copies HIV-1 RNA/mL but can provide a qualitative assessment of the presence of HIV-1 RNA below the 20 copy range. The presence of HIV-1 RNA in plasma was also qualitatively assessed using nucleic acid testing using a transcription-mediated amplification (TMA) based detection method as described by the manufacturer (Procleix Ultrio Plus, Novartis) with 50% sensitivity at 3.8 copies/mL and 95% sensitivity at 12 copies/mL [30 (link)]. TMA results were considered binary and defined as positive or negative according to assay outcomes.
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6

HIV RNA Quantification in Plasma and HSP

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HIV RNA concentration was quantified in plasma and HSP pool of HIV infected donors using COBAS TaqMan HIV-1 test V2.0 according to manufacturer’s instructions (Roche Diagnostics, Monza, IT). The assay has a lower limit of detection of 20 HIV RNA copies/mL and a linear range of detection up to 20 – 1 x 107 copies/mL.
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7

Longitudinal Neuroimmune Monitoring in HIV

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Clinical and laboratory parameters were assessed at baseline, week 24, and week 96. CD4+ T cell count was measured by single- and dual-platform flow cytometry (Becton-Dickinson). HIV-1 RNA in plasma was performed using the COBAS AMPLICOR HIV-1 Monitor Test v1.5 or COBAS TaqMan HIV-1 Test v2.0 (Roche Molecular Systems), with lower limits of quantification (LLQ) of 50 and 20 copies/mL, respectively. CSF samples were run in batch and diluted fourfold for volume requirements for detection of HIV-1 RNA, with an LLQ of 80 copies/mL using the TaqMan platform. HIV-1 RNA measurements below the LLQ that tested positive were designated detectable but not quantifiable. Neuropsychological testing was performed at standardized intervals at weeks 0, 12, 24, and 96 [11 (link)].
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8

Integrated Substance Use and HIV/HCV Assessment

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At each RDSS, urine testing (Drug-screen Multi 7A carte, Nal von Minden, Germany) results were recorded. Then, face-to-face structured and standardised interviews, which included declarative information concerning drug use, sexual behaviours, and involvement in drug-related and HIV-related services, were administered by trained CBO members. After providing information on HIV and hepatitis C virus (HCV) testing, blood samples were collected and tested for HIV serology (using national guidelines) and HCV serology (SD BIOLINE HCV rapid test, SD Standard Diagnostic Inc, South Korea) by nurses on site. For all HIV-seropositive participants, these collected blood samples were also used for HIV viral load quantification (COBAS Taqman HIV-1 test v2.0, Roche diagnostics, Vietnam), at the HIV control program reference laboratory and for lamivudine detection among all PWID with HIV RNA >1000 cp/mL using high pressure liquid chromatography with ultraviolet detection, as previously described.22 (link)
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9

Incidence and Characteristics of HIV

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A total of 1157 HIV cases were newly diagnosed between January 2015 and December 2017 in Dehong Dai and Jingpo Nationality Autonomous Prefecture (Dehong prefecture). Among these newly diagnosed cases, 1152 cases were tested by the serological LAg-EIA assay (Beijing Kinghawk Pharmaceutical Co., Ltd, China) to classify recent infection status; the coverage of recent infection testing was 99.6%. The plasma level of HIV-1 RNA was quantified using the COBAS TaqMan HIV-1 test (v2.0) (Roche, US). A CD4+ T cell count was performed on FACS Calibur flow cytometry (BD Biosciences, US). All laboratory assays were performed at the Dehong Center for Disease Control and Prevention (CDC). Due to a lack of specimens, or other reasons, some cases were missing data on CD4+ T cell count and viral load.
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10

Monitoring HIV Incidence and ART Adherence among PWID

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The participants included were part of the DRIVE study17 which between 2016–2018 recruited a cohort of PWID in Hai Phong Vietnam using respondent driven sampling. We enrolled all HIV positive and a sample of HIV negative PWID into a cohort to monitor HIV incidence, associated risk behaviors, and use of intervention and support services.
Eligible participants had to be injecting drugs, at least 18 years of age, and capable of giving informed consent. Injection drug use was verified through the examination of injection marks and urinalysis for heroin and/or methamphetamine use.
Each participant received counseling and testing for HIV. HIV antibody testing was conducted using Bioline HIV1/2 3.0 rapid test (Standard Diagnostics Inc. Gyeonggi-do, Republic of Korea). Confirmation testing was conducted using Determine HIV-1/2 (Alere, Waltham, MA, USA) plus the VIKIA® HIV1/2 (Marcy l’Étoile, Lyon, France). HIV viral load was measured at the national reference laboratory (NIHE, Hanoi) using the COBAS Taqman HIV-1 test v2.0 (Roche diagnostics, Hanoi, Vietnam).
We restricted our sample to visits where PWID reported receiving ART, had non missing self-report methamphetamine use and ART adherence scores and HIV viral load measurements from laboratory tests.
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