COBAS® AmpliPrep/COBAS® TaqMan® CMV Test 

 
Registration Status
 
Canada-IVD
CE-IVD
US-IVD

 

Dependable CMV monitoring

Improve disease management and patient care with a Roche real-time, fully automated PCR test

A viral load test used to quantify the amount of Cytomegalovirus in human plasma of CMV infected individuals.  The test is used as an aid in the management of patients at risk for CMV-infection and/or undergoing anti-viral therapy after solid organ or bone marrow transplantation.

Features and Benefits

 

Standardization

  • The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is traceable to the WHO 1st International Standard.
  • Meets unmet medical need to develop international cutoff values.
  • Future evidence-based treatment guidelines will be enabled by viral load results that can be generated in clinical utility studies globally, using a well standardized assay.

 

High precision, sensitivity, and reproducibility

  • Reliably monitor CMV infection and the effect of antiviral therapy

 

Fully automated workflow

  • Simplify your work load by reducing hands-on time while minimizing manual preparation and errors for increased overall efficiency. Offers convenience of parallel processing with other viral load monitoring tests (HIV, HCV, and HBV)

 

Good correlation to COBAS® AMPLICOR CMV Monitor Test

  • Facilitates transition from COBAS® AMPLICOR CMV Monitor Test to The COBAS® AmpliPrep/COBAS® TaqMan® system

Intended Use

 

The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is an in vitro nucleic acid amplification test for the quantitation of cytomegalovirus DNA 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 CMV DNA over the range of 150 - 10,000,000 copies/mL.  One copy of CMV DNA (as defined by the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test) is equivalent to 0.91 International Unit (IU) on the First WHO International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC 09/162).

 

The test is intended to be used in conjunction with clinical presentation and other laboratory markers in the diagnosis and management of CMV infection in patients at risk for CMV disease.

 

The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is not intended for use as a screening test for the presence of CMV in blood or blood products or as a diagnostic test to confirm the presence of CMV infection. The results from the COBAS AmpliPrep/COBAS TaqMan CMV Test must be interpreted within the context of all relevant clinical and laboratory findings.

 

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 Instruments