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

 
Registration Status

Canada-IVD
CE-IVD
Japan-IVD
US-IVD
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.
 
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
 
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. 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 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 anti-retroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of anti-retroviral 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.
 
More Information
 
For regulatory reasons we are not able to provide further details on our products on this website, but more information may be available from our regional sales representatives.
 
 
Contact

Contact your local sales representative for detailed information, questions and ordering.

 

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