Roche Diagnostics

Research and Development

Innovation

AMPLICOR® Products

Clinical Recognition

 

Clinical Recognition of
AMPLICOR® Products

AMPLICORâ Products as a Gold Standard in HIV Viral Load Testing

The AMPLICOR HIV-1 MONITORä Test is one of the most commonly available viral load testing systems in the world. This was the first test method to be approved by the FDA in the USA and used world-wide to accurately and precisely measure the quantity of circulating HIV-1 RNA in human plasma.

This background has led to the adoption of the AMPLICOR HIV-1 MONITOR™ Test internationally as the ‘gold standard’ in viral load testing.

Since acquiring the rights to PCR technology in 1991, Roche Diagnostics has made AMPLICORâ PCR tests the leading DNA probe products in the world.

AMPLICOR HIV-1 MONITOR™ and clinical trials

The adaptation of PCR techniques to the routine, clinical laboratory setting, allowing sensitive and rapid diagnosis and monitoring of viral infections in patients, over recent years has been one of the most notable achievements in this area in recent years. The sensitivity of PCR testing in particular, facilitates the diagnosis of infectious agents earlier.

The key HIV clinical trials, which shaped the clinical management of HIV, used the AMPLICOR HIV-1 MONITOR™ Test and reinforced its credibility through versatility, speed, accuracy and consistency.

As AMPLICORâ Products are used as a preferred system for evaluation in clinical trials, they are increasingly used as a benchmarking technique for all research in this area. Some key clinical trials in which AMPLICORâ Products have been used are:

  • ACTG trials (including 175 and many others)
  • DELTA trial
  • CHEESE study
  • INCAS study
  • SPICE study

 

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