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COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0

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Greater security against the unexpected

Enabling advanced and reliable detection with a dual-target approach

 

The dual-target COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 enhances the reliability of HIV-1 viral load results and provides greater confidence while assessing disease and patient management.

It is an in vitro nucleic acid amplification test for the quantitation of HIV-1 RNA in human plasma that targets two highly conserved regions of the HIV-1 genome, not subject to drug pressure. In doing so, it compensates for the possibility of mutations or mismatches and increases the probability of detection.

Features and benefits

Test confidently and accurately, avoiding under-quantification

  • Targets two unique regions of the HIV-1 genome, gag and LTR, which are not subject to selective drug pressure
  • AmpErase enzymes reduce the risk of cross-contamination of samples or labs
  • Provides diagnostic accuracy of test results even if mutations occur in one of the two regions
  • Confidently detect HIV-1 variants and potentially avoid under quantification
  • Accurate quantification of HIV-1 RNA with a dual target assay contributes to optimal treatment decisions for patient management

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Intended use

Intended use

The COBAS® AmpliPrep/COBAS®  TaqMan® HIV-1 Test, version 2.0 (v2.0) is an in vitro nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma using the COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or COBAS® TaqMan® 48 Analyzer for automated  amplification and detection. The test can quantitate HIV-1 RNA over the range of 20 – 10,000,000 copies/mL (33 to 1.67 x 107 International Units [IU]/mL). One copy of HIV-1 RNA is equivalent to 1.67 IU based on the WHO 1st International Standard for HIV-1 RNA for Nucleic Acid-Based Techniques (NAT) (NIBSC 97/656).

This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 group M and HIV-1 group O infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment.

The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test v2.0 is not intended for use as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic test to confirm the presence of HIV-1 infection.

 

The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, version 2.0 (v2.0) is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma using the COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or COBAS®  TaqMan® 48 Analyzer for automated amplification and detection. The test can quantitate HIV-1 RNA over the range of 20 – 10,000,000 copies (cp)/mL. One copy of HIV-1 RNA is equivalent to 1.7 ± 0.1 International Units (IU) based on the WHO 1st International Standard for HIV-1 RNA for Nucleic Acid-Based Techniques (NAT) (NIBSC 97/656).

This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment.

The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 is not intended for use as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic test to confirm the presence of HIV-1 infection.

 

Enhanced reliability with a dual-target approach

Rely on the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, version 2.0 (v2.0) for enhanced security and greater confidence when assessing HIV viral loads.

Registration status

CE-IVD; US-IVD

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

Performance

  • Sample type

    EDTA plasma

  • Sample processing volume

    1000 µL

  • Analytical sensitivity (LoD by hit rate of ≥ 95%)

    20 HIV-1 RNA copies/mL

  • Linear range

    20 – 1 x 107 HIV-1 RNA copies/mL

  • Specificity

    100%

  • Genotypes detected

    HIV-1 Group M subtypes A-H, Group O

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