COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test  

 
Registration Status

Canada-IVD
CE-IVD
Japan-IVD
US-IVD
Fully automated Human Immunodeficiency Virus Type 1 (HIV-1) quantification test
A fully automated sample preparation, amplification and detection test that utilizes real-time polymerase chain reaction (PCR) and fluorescence resonance energy transfer (FRET) to quantify HIV-1 RNA in human plasma.
Features and Benefits
 
Features
  • Highly sensitive and accurate
  • Delivers highly accurate results faster
Benefits
  • A fully automated, docked platform combines the COBAS® AmpliPrep Instrument for automated sample preparation and the COBAS® TaqMan® Analyzer for automated real-time PCR amplification and detection
  • "Sample in/results out" testing eliminates manual intervention between steps while improving workflow efficiency, hands-off processing, and test result integrity
  • Configuration options, including an undocked station and a smaller COBAS® TaqMan® 48 Analyzer for customizable workflow throughput
  • Bar coded reagents packaged in ready-to-use, spill-proof cassettes with self-sealing caps for increased stability
  • Bar coded samples improve tracking and result integrity
  • AmpErase enzymes reduce the risk of cross-contamination of samples or labs
  • Quantification of HIV-1 RNA from 40 copies/mL to 10,000,000 copies/mL (CE-IVD kits) and 48 copies/mL to 10,000,000 copies/mL (FDA-IVD)
Intended Use
 
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 anti-retroviral 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 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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