The US Food and Drug Administration (FDA) has approved the first cytomegalovirus (CMV) test for use in hematopoietic stem cell transplant (HSCT) recipients.
With this approval, the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is available for monitoring CMV treatment in all types of transplant patients in the US.
The test, which was developed by Roche, is an in vitro nucleic acid amplification test that quantitates CMV DNA in human plasma.
It is intended to aid the management of HSCT recipients and solid-organ transplant recipients who are undergoing anti-CMV therapy.
In this population, serial DNA measurements can be used to assess virological response to antiviral treatment. The results from the test must be interpreted within the context of all relevant clinical and laboratory findings.
The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is not intended for use as a screening test for the presence of CMV DNA in blood or blood products.
The test is designed for use on the automated COBAS® AmpliPrep/COBAS® TaqMan® System, an established platform for viral load monitoring of multiple infectious diseases.
The system combines the COBAS® AmpliPrep Instrument for automated sample preparation and the COBAS® TaqMan® Analyzer or the smaller COBAS® TaqMan® 48 Analyzer for automated real-time PCR amplification and detection.
The COBAS® AmpliPrep/COBAS® TaqMan® System has parallel processing with other molecular diagnostics assays targeting other diseases. Roche’s AmpErase enzyme is also included in each test and is designed to prevent cross-contamination of samples and labs.
