Qiagen artus CMV RGQ MDx Kit

Qiagen’s artus CMV RGQ MDx Kit for human cytomegalovirus (CMV) has been approved by the US Food and Drug Administration (FDA) under a full premarket approval (PMA). The PCR-based assay is optimised for low- to mid-throughput testing of CMV.

CMV testing is primarily used as an aid in the management of solid organ transplant patients to assess viral load in response to antiviral drug therapy. These patients are at high risk of life-threatening CMV infections in the months following surgery, and antiviral drug treatment is standard. Between 20 and 60% of all transplant patients, depending on patient and procedure, are repeatedly tested for CMV throughout the first year following transplantation.

Qiagen’s CMV assay is claimed to be the fastest test approved for quantifying CMV viral loads in organ transplant patients. In addition to helping save lives, the test reduces the time and money labs and hospitals currently spend validating lab-developed CMV tests and analyte-specific reagents. The assay has a turnaround time of approximately 3 h and runs on Qiagen’s Rotor-Gene Q MDx real-time PCR platform, a member of the QIAsymphony modular family of automated instruments.