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Ampliprep cobas taqman hiv 1 test v 2

Manufactured by Roche
Sourced in United States

The AmpliPrep/Cobas TaqMan HIV-1 test v 2.0 is a laboratory diagnostic tool used for the quantification of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma.

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5 protocols using ampliprep cobas taqman hiv 1 test v 2

1

Lymph Node Biopsy HIV Patients

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Samples from 9 HIV-uninfected subjects, 19 subjects on suppressive ART, and 9 viremic individuals not receiving ART at the time of sampling were used in this study. None of the participants under ART had detectable plasma viremia at the time of the study, as assessed by viral load measurements using AmpliPrep/Cobas TaqMan HIV-1 test v 2.0 (Roche), with a detection limit of 20 HIV RNA copies/ml of plasma. All participants underwent lymph node biopsy (inguinal lymph nodes), and blood was collected at the same time. Subject characteristics are summarized in Table 1. These studies were approved by the Institutional Review Board of the Centre Hospitalier Universitaire Vaudois, and all subjects gave written informed consent.
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2

Diagnostic Accuracy of HIV-1 RNA VL

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This was a prospective diagnostic accuracy study. Each study participant provided 12 ml of venous blood collected in EDTA tubes for the preparation of fresh plasma, DBS, and FDPS samples. Three VL tests were carried out for each participant, and clinical decisions were based on the results of VL tests carried out on fresh plasma as part of the standard of care. HIV-1 RNA VLs were measured using the Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test, v2.0 (CAP/CTM), system, one of the most commonly used HIV VL testing platforms in low- and middle-income countries (12 ) with acceptable accuracy (13 (link)).
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3

HIV-1 RNA Quantification and CD4 Enumeration

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A 5-mL blood sample was collected from each patient into a blood collection tube treated with EDTA. CD4 T cell count was obtained using flow cytometery (Cytomics FC 500, Beckman Coulter, Inc., Switzerland). Cells were labeled using tetra-chrome™ CD45-FITC/CD4-RDI/CD8-ECD and CD3-PC5. The levels of HIV-1 RNA in the plasma were measured using COBAS Kit (AmpliPrep/COBAS TaqMan HIV-1 Test v2.0; Roche Molecular Diagnostics, USA) according to the manufacturer instructions.
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4

Quantification of HIV-1 RNA in Biological Fluids

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Quantification of HIV-1 RNA in plasma and cerebrospinal fluid samples was carried out with clinical routine assays and three different automated platforms during the observation period between January 2011 and October 2022. Until December 2014, the Abbott RealTime HIV-1 assay was used on the Abbott m2000 system. From January 2015 to July 2021, HIV-1 RNA quantification was performed on the Roche CAP/CTM using the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test v.2.0. Since August 2021, quantification has been performed on the Roche c6800 system using the COBAS HIV-1 Test Kit. All analyses were carried out according to the manufacturer’s instructions with a detection limit of 40 copies per ml (Abbott) and 20 copies per ml (Roche).
Ultrasensitive residual viremia was measured in 9 ml of plasma after ultracentrifugation at 170,000g at 4 °C for 30 min, followed by viral RNA extraction using the m2000sp Abbott RealTime HIV-1 assay and laboratory-defined application software from the instrument15 (link). HIV-1 RNA was quantified with a validated in-house calibration curve set with a limit of detection of 0.56 copies per ml.
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5

Viral Marker Quantification in Plasma

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HBV serological markers were measured using immune-enzymatic assays (Roche/Cobas Diagnostics, Rotkreuz, Switzerland). Plasma HBV-DNA was detected using real-time polymerase chain reactions (20 IU/mL lower limit of quantification) (Roche/Cobas Ampliprep/Cobas Taqman, Rotkreuz, Switzerland). Plasma HIV-RNA levels were measured using a commercial test with 20 cp/mL HIV-RNA as the lower limit of quantification (COBAS Ampliprep/Cobas Taqman HIV-1 Test, v2.0), as described in a previous study19 (link).
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