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Taqman hiv 1 test

Manufactured by Roche

The TaqMan HIV-1 test is a real-time PCR assay designed for the quantitative detection of HIV-1 RNA in human plasma. It provides accurate and reliable viral load measurements to monitor HIV-1 infection.

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4 protocols using taqman hiv 1 test

1

Virologic Outcomes After ART Failure

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The primary outcome was ART failure within 12 months of surgery, defined by the US Department of Health and Human Services (DHHS) as failure to suppress or sustain an HIV viral load to less than 200 copies/mL [17 ]. Due to the long length of the study period, various assays were used to detect viral load including the Roche COBAS Ampliprep/COBAS TaqMan HIV-1 test with a lower limit of detection of 20 copies/mL most recently, branched DNA tests with a lower limit of detection of 75 copies/mL, and others. Secondary outcomes included characterizing those who suffered virologic failure compared to those with sustained virologic suppression in terms of metabolic parameters, CD4+ count, acid suppression use, postoperative complications, ART regimen changes, adherence, and resistance.
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2

Long-term Virologic Outcomes in HIV

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The primary efficacy endpoint represented the proportion of patients with confirmed and sustained virologic response (VR [VL of <50 copies/mL]) according to the time to loss of VR (TLOVR) algorithm at week 24 and was presented in a previous publication (10 ). The secondary efficacy endpoints at week 240 were the proportion of patients with VR using the FDA Snapshot approach (26 ), TLOVR (27 ), and change in CD4+ cell count (absolute and percentage) from baseline up to week 240.
Plasma VL was assessed at prespecified time points using the Roche Cobas Amplicor HIV-1 Monitor test, version 1.5 (lower limit of quantification [LLOQ], 50 copies/mL [until the end of 2012]), or the Roche Cobas TaqMan HIV-1 test, version 2.0 (LLOQ, 20 copies/mL [after 2012]).
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3

Assessing Immune Status in HIV Patients

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The percentage of lymphocytes that were CD4+ T cells was determined by flow cytometry. HIV viral load was determined via either the COBAS TaqMan HIV-1 Test, version 2.0, or Roche Amplicor HIV-1 MONITOR Test, version 1.5. Both tests quantify HIV-1 RNA based on in vitro amplification of the highly conserved HIV-1 gag gene. Nadir CD4+ T cell count was obtained either by self-reports or, for those who seroconverted during the course of the study, their lowest CtaD4+ count according to study records. Duration of infection was calculated based on self-reported year of conversion or study records if they seroconverted while in the MACS.
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4

Measuring HIV Viral Load Suppression

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One of three assays were used for measuring VL: Amplicor HIV-1 monitor test (Roche Diagnostics, lower limit of detection [LLD]=400 copies/mL, Pre-2002: 11%); Amplicor HIV-1 monitor ultrasensitive test (Roche Diagnostics, LLD=50, 2002–2010: 64%); TaqMan HIV-1 test (Roche Diagnostics, LLD=20, 2011–2015: 25%). VLs below the LLD were set to 300, 40 and 10 copies/mL, respectively, per MACS operating protocols. Longitudinal VL data were measured at semiannual study visits. For cART-prevalent individuals, the last VLs within 6 months before cART initiation were abstracted from medical records.
Viral suppression was defined as consistent VL measurements below the LLD allowing one blip <400 copies/mL. Using this definition, proportions of virally suppressed participants were calculated at single time-points (the last pre-cART, first post-cART and most recent visits) and over various time windows (as explained below).
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