COBAS® AMPLICOR HIV-1 MONITOR Test, v1.5 

 
Registration Status

Canada-IVD
CE-IVD
Japan-IVD
US-IVD
Human Immunodeficiency Virus Type 1 (HIV-1) viral load quantification
An in vitro nucleic acid amplification test* for the quantification of HIV-1 RNA in human plasma.
 
This test uses the COBAS® AMPLICOR Analyzer to automate PCR amplification and detection.
Features and Benefits
 
Features
  • Gold standard automated solution for HIV-1 viral load testing
  • Proven performance in major pharmaceutical trials
Benefits
  • High levels of sensitivity for accurate measurement of viral suppression in patients on anti-retroviral therapy
  • Greater than 99.85% specificity
  • Quantification of HIV-1 RNA from 50 to 750,000 copies/mL
  • Platform automation may contribute to greater laboratory productivity
Intended Use
 
The test is intended for use in conjunction with clinical presentation and other laboratory markers for prognostic assessment of HIV-1 infected patients, and for monitoring the effects of anti-retroviral therapy by serial measurement of plasma of HIV-1 RNA for patients with baseline viral loads equal to or greater than 25,000 copies of HIV-1 viral RNA/mL.
 
The COBAS® AMPLICOR HIV-1 MONITOR Test, v1.5 is not intended to be used as a screening test for blood or blood products for the presence of HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.
*Two different specimen preparations: UltraSensitive and Standard.
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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