PCR Assay Monitors CMV in Immunocompromised Patients

The assay has received the CE mark under the European Directive for in vitro diagnostic (IVD) medical devices. Intended for rapid detection and quantitation of CMV viral load, the assay monitors patients for infections that can be asymptomatic and lead to latent infection and reinfection. CMV, which is a herpes virus, is a significant cause of infection and mortality among immunocompromised patients, such as organ transplant recipients andAIDS and cancer patients.

Detection of active CMV infection plays a critical role in diagnosis and treatment. Periodic monitoring of CMV viral load in consecutive clinical samples is used to identify high-risk patients and to monitor their response to CMV therapy. Because of their specificity and sensitivity, real-time PCR diagnostics such as Smart CMV are an important tool in the effective clinical management of CMV patients.

Professor Mario Poljak, M.D., Ph.D., head of the Laboratory for Molecular Microbiology and the Slovenian AIDS Reference Center at the University of Ljubljana (Slovenia) said, "In transplant recipients, CMV load is used to diagnose active CMV disease, screen patients for the use of preemptive therapy, and monitor the response to antiviral therapy. In patients infected with human immunodeficiency virus type 1, the risk of developing CMV disease has been reported to be directly related to the quantity of CMV DNA in plasma.”

By automating the amplification and detection process, the SmartCycler system delivers accurate and consistent test results from prepared biologic samples in approximately 30-40 minutes. With up to 96 independently programmable reaction sites, the system can simultaneously run different tests with different protocols and at different times. This eliminates complex advanced scheduling on larger, more costly systems as well as the need to transport samples to central facilities for analysis.

Cepheid is a molecular diagnostics company that develops, manufactures, and markets fully-integrated systems for genetic analysis in the clinical, industrial, and biothreat markets. The company's systems enable rapid genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures.



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