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

A dual-target approach for greater security against the unexpected

Advanced and reliable detection with a dual-target approach

An in vitro nucleic acid amplification test for the quantitation of HIV-1 RNA in human plasma that targets two regions of the HIV-1 genome.

This test enhances the reliability of test results and provides greater confidence in assessing viral loads. It also increases the probability of detection and expands coverage by targeting two highly conserved regions of the HIV-1 genome to compensate for the possibility of mutations or mismatches.

This test uses the COBAS® AmpliPrep Instrument to automate specimen processing and the COBAS® TaqMan® Analyzer or COBAS® TaqMan® 48 Analyzer to automate amplification and detection.

Features and Benefits

Features

  • Dual-target approach for greater security against the unexpected
  • Highly sensitive and accurate
  • AmpErase enzymes reduce the risk of cross-contamination of samples or labs

Benefits

  • Provides diagnostic accuracy of test results even if mutations occur in one of the two regions
  • Compensates for the possibility of mismatch occurring with a primer/probe region
  • Ensures enhanced reliability of test results and more confidence in assessing viral loads
  • Offers primers and probes that are used to amplify the gag and LTR regions
  • Provides LTR primers that have broad genotype inclusivity and are well conserved phylogenetically
  • Quantifies the clinically significant HIV-1 groups and subtypes with full subtype coverage and quantification of HIV-1 groups O and M
  • Quantitates HIV-1 RNA from 20 – 10,000,000 copies/mL
  • Offers increased sensitivity and linear range for accurate measurement of viral suppression
  • Has a lower limit of detection (LOD) and 100% specificity at 20 copies/mL than previously available HIV-1 tests
  • Is fully traceable to WHO international standards

 

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) 36.

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.

NOTE: The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 exhibits a higher level of
sensitivity compared with the COBAS® AMPLICOR HIV-1 MONITOR Test, v1.5 and the COBAS®
AmpliPrep/COBAS® TaqMan® HIV-1 Test, reporting values ≥ 20 cp/mL that were undetectable
or < Lower Limit of Quantitation (LLoQ) in these methods.