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Cobas ampliprep cobas taqman hiv 1 assay version 2.0

Manufactured by Roche
Sourced in United States

The COBAS AmpliPrep/COBAS TaqMan HIV-1 Assay (version 2.0) is an in vitro nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma. The assay utilizes automated sample preparation and real-time PCR technology to detect and quantify HIV-1 viral load.

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10 protocols using cobas ampliprep cobas taqman hiv 1 assay version 2.0

1

Quantifying Plasma HIV-1 RNA Levels

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Plasma HIV-1 RNA levels were determined at every study visit, including the screening (day −49 to −7) and pre-infusion (day −42 to −2) visits, as well as before the first infusion on day 0 and two days after each infusion. Following the last infusion, HIV-1 RNA levels were monitored weekly for four weeks, and continued to be monitored in two- to eight-week intervals until the end of study follow up. HIV-1 RNA levels were determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Assay (version 2.0) or the Roche cobas HIV-1 quantitative nucleic acid test (cobas 6800). These assays have a linear range of quantitation between 2 × 101 and 1 × 107 viral copies/ml and were performed at LabCorp or at the University Hospital Cologne.
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2

Monitoring Plasma HIV-1 RNA Levels

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Plasma HIV-1 RNA levels were determined at every study visit, including the screening (day -49 to -7) and pre-infusion (day -42 to -2) visits, as well as before the first infusion on day 0 and two days after each infusion. Following the last infusion, HIV-1 RNA levels were monitored weekly for four weeks, and continued to be monitored in two- to eight-week intervals until the end of study follow up. HIV-1 RNA levels were determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Assay (version 2.0) or the Roche cobas HIV-1 quantitative nucleic acid test (cobas 6800). These assays have a linear range of quantitation between 2 × 101 and 1 × 107 viral copies/ml and were performed at LabCorp or at the University Hospital Cologne.
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3

Quantifying HIV-1 RNA Levels During Analytic Treatment Interruption

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HIV-1 RNA levels in plasma were measured at the time of screening, at week -2, day 0 (before infusion), weekly during ATI, and every two weeks to every eight weeks after viral rebound had occurred. HIV-1 RNA levels were determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Assay (version 2.0) or the Roche cobas HIV-1 quantitative nucleic acid test (cobas 6800), which quantitate HIV-1 RNA over a range of 2x101 to 1×107 copies/ml. These assays were performed at LabCorp or at the University Hospital Cologne.
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4

Measuring HIV-1 RNA Levels Over Time

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HIV-1 RNA levels in plasma were measured at the time of screening (within 49 days before the first infusion), day 0 (before infusion), and weekly until week 12, then at weeks 14, 24 and 36. Participants that remained virologically suppressed to <20 c.p.m. off ART beyond week 12, returned for weekly measurements of plasma HIV-1 RNA levels. HIV-1 RNA levels were determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Assay, Version 2.0, which detects between 20 and 1 × 107 c.p.m. This assay was performed at LabCorp.
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5

Quantifying HIV-1 RNA Levels During ATI

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HIV-1 RNA levels in plasma were measured at the time of screening, at week −2, day 0 (before infusion), weekly during ATI, and every two weeks to every eight weeks after viral rebound had occurred. HIV-1 RNA levels were determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Assay (version 2.0) or the Roche cobas HIV-1 quantitative nucleic acid test (cobas 6800), which quantitate HIV-1 RNA over a range of 2×101 to 1×107 copies/ml. These assays were performed at LabCorp or at the University Hospital Cologne.
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6

Quantifying HIV-1 RNA Levels

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HIV-1 RNA levels in plasma were measured at the time of screening, at week −2, day 0 (before infusion), weekly during ATI, and every two weeks to every eight weeks after viral rebound had occurred. HIV-1 RNA levels were determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Assay (version 2.0) or the Roche cobas HIV-1 quantitative nucleic acid test (cobas 6800), which quantitate HIV-1 RNA over a range of 2 × 101 to 1 × 107 copies per ml. These assays were performed at LabCorp or at the local laboratory at Massachusetts General Hospital.
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7

Longitudinal HIV-1 RNA Quantification

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Plasma was collected for measuring HIV-1 RNA levels at screening (from d −49 to d −7), the pre-infusion visit (from d -42 to d -1), day 0 (before infusion), and on days 1, 2, 4, 7, 14, 21, 28, 42, 56, 84, 112, 140 and 168. HIV-1 RNA levels were determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Assay, Version 2.0, or the Roche Cobas 6800 HIV-1 kit, which detect 20–10×106 copies/ml.
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8

Measuring Residual HIV Viremia

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Plasma HIV-1 RNA was quantified using the Cobas AmpliPrep/CobasTaqMan HIV-1 assay version 2.0 (Roche Diagnostics; lower detection limit of 20 copies/mL). Below this cutoff, the assay indicates the qualitative detection of pHIV-1 RNA in the range of 1 to 20 copies/mL. Residual viremia was measured at baseline and W96: USVL was between 1 and 20 copies/mL when a signal was detected and below 1 copy/mL when there was no detected signal. The measure of USVL was centralized for each trial.
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9

CSF HIV-1 RNA Quantification

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CSF HIV-1 RNA was measured with COBAS® Ampliprep/COBAS® Taqman® version 2.0 HIV-1 assay (Roche Molecular Systems, Inc, Branchburg, NJ, USA); this assay detects 20 to 10,000,000 copies/mL, with 98.3% sensitivity and 99.4% specificity.
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10

Quantifying HIV-1 RNA in Plasma and CSF

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Plasma and CSF HIV-1 RNA were measured using the COBAS® Ampliprep/COBAS® Taqman® version 2.0 HIV-1 assay (Roche Molecular Systems, Inc., Pleasanton, CA)26 (link) which detects 20–10,000,000 copies/mL in plasma, with a sensitivity of 98.3% and specificity of 99.4%. Commercial reverse transcriptase PCR assays have been shown to successfully quantitate HIV-1 RNA in other biological compartments, including CSF.27 (link) Because dilution of samples was performed to achieve proper volume necessary for HIV-1 RNA quantification, the lower limit of detection for CSF and plasma samples in this study was 40 copies/mL.
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