Quest Diagnostics Inc’s Focus Diagnostics business has CE marked its new Simplexa Cytomegalovirus (CMV) molecular test kit on the 3M™ Integrated Cycler for distribution to approximately 35 countries in Europe. The test is designed to enable hospital labs to perform advanced molecular testing for CMV, a potentially fatal virus infection in patients with compromised immunity, particularly those undergoing organ transplantation.
As with other members of the herpes virus family, CMV is typically latent after primary infection. It can reactivate when the immune system is significantly weakened, such as following organ transplantation, and cause fever, organ rejection and even death. The Simplexa CMV test employs real-time polymerase chain reaction to quantitatively detect CMV in whole blood specimens and plasma.
“The ability to detect and quantify CMV and other viruses known to affect organ transplant and other immunocompromised patients is critical to patient care,” said Jay M. Lieberman, MD, medical director, infectious disease, Quest Diagnostics and Focus Diagnostics. “With our Simplexa CMV and other test products, physicians in hospitals and other facilities with molecular labs can more quickly get the laboratory results they need to manage their at-risk patients and avoid potentially life-threatening complications.”
In early 2011, Simplexa EBV and Simplexa BK quantitative assays were granted CE-IVD status. Focus Diagnostics also offers molecular primer pairs for the development of laboratory tests, including JC virus, Varicella-Zoster Virus (VZV), adenovirus and human herpesvirus-6 (HHV-6).
Source: Quest Diagnostics