COBAS® TaqMan® HIV-1 Test, v2.0 For Use With The High Pure System 

 
Registration Status

CE-IVD
State-of-the-art dual target technology now available for all COBAS® TaqMan® HIV customers
An advanced and reliable HIV-1 viral load detection with a dual-target approach

A viral load test* used to quantify the amount of Human Immunodeficiency Virus Type 1 (HIV-1) in human plasma of HIV infected individuals. The test is used as an aid in the management of HIV infected patients undergoing anti-viral therapy. 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.

 

Features and Benefits

 

Features

  • All COBAS® TaqMan® HIV-1 Assays are fully traceable to WHO International Standards
  • The test uses the High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS® TaqMan® 48 Analyzer for automated amplification and detection.
  • The test can quantitate HIV-1 RNA over the range of 34 to 10,000,000 copies/mL.

 

Benefits

  • Enhanced reliability and greater security of test results in the increasing presence of mutations
    • Dual target approach expands coverage and provides additional security in the event of a mutation in one of the primer/probe regions
  • Global Surveillance Program ensures current and future products remain state of the art
    • There are over 26,000 HIV-1 sequences in the database

Intended Use

 

The COBAS® TaqMan® HIV-1 Test, version 2.0 (v2.0) For Use With The High Pure System 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 High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS® TaqMan® 48 Analyzer for automated amplification and detection. The test can quantitate HIV-1 RNA over the range of 34 to 10,000,000 copies/mL. One copy of HIV-1 RNA is equivalent to 1.7 ± 0.1 International Units (IU) based on the World Health Organization 1st International Standard for HIV-1 RNA (NIBSC code 97/656)

 

The 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® TaqMan® HIV-1 Test, v2.0 is not intended to be used 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® TaqMan® HIV-1 Test, v2.0 For Use With The High Pure System is not available in the United States.
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.

 

Browse Our Products

 

 Related Assays

 Related Instruments