Varicella-Zoster Virus Assay Now has CE IVD Mark
The Cepheid Smart VZV Assay for clinical diagnostic use on the SmartCycler® System has now been released as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices.
Smart VZV is intended for rapid detection of the varicella-zoster virus, a member of the herpes virus subfamily, the cause of potentially life-threatening complications of the lungs, liver and central nervous system in immunocompromised children. The virus can also cause serious eye, kidney and brain infections also known as retinitis, acute renal necrosis and chronic progressive encephalitis respectively in HIV patients. In addition, VZV the cause of herpes zoster (shingles), may be confused with herpes simplex virus and appropriate laboratory tests are often required for support of the correct diagnosis and subsequent treatment.
"Multiple data indicate that PCR analysis is more efficient than antigen or antibody testing or viral culture. Now swab specimens obtained from skin and mucosa in addition to cerebrospinal fluid of patients with aseptic meningitis and encephalitis can be used for rapid and sensitive detection of varicella-zoster virus (VZV) via real time PCR," said Professor Jacques Izopet, Head of the Clinical Virology Laboratory, University Hospital of Toulouse. "The results are highly relevant for optimization of specific antiviral therapy for these patients."
Real-time PCR is a reliable tool for detection of VZV in patients who have developed or are at risk for developing active VZV infection. PCR is especially important in cerebrospinal fluid (CSF) samples where standard viral culture procedures are relatively insensitive.
The Smart VZV Assay offers a standardized qualitative method that can be used for the detection of VZV DNA in vesicle swabs and CSF samples. The assay offers a highly sensitive limit of detection. The use of an internal control greatly minimizes the risk of false negative results.
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