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

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.

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

Intended use

CE-IVD:

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.

US-IVD:

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.

Performance

Parameters Performance
Sample type EDTA plasma, serum
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 100.00%
 Genotypes detected HIV-1 Group M subtypes A-H, Group O

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.