HSV 1 & 2 direct molecular test for aiding the diagnosis of encephalitis
The Simplexa HSV 1 & 2 direct molecular test running on the 3M Integrated Cycler is the first molecular test to be cleared by the FDA for the qualitative detection and differentiation of herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) in cerebrospinal fluid (CSF) from patients suspected of HSV central nervous system (CNS) infection, including encephalitis. The test uses a proprietary process that eliminates nucleic acid extraction, so clinicians can expect results within about an hour after providing a specimen for testing. Encephalitis is an inflammation of the brain oft en caused by the herpes simplex or other viruses. The Infectious Diseases Society of America (IDSA) recommends herpes simplex PCR testing on all CSF specimens in patients with encephalitis. HSV encephalitis occurs in all ages and during all seasons, with HSV-1 encephalitis more common in adults and HSV-2 encephalitis more common in newborn infants. Accurate determination of the virus-causing encephalitis can influence treatment decisions and outcomes. The moderate complexity categorization of the Simplexa HSV 1 & 2 Direct molecular test significantly broadens the potential clinical access to the technology. Moderate complexity laboratories, defined by the Clinical Laboratory Improvement Amendments (CLIA), include certain types of physician’s offices, community hospitals, health clinics and integrated delivery networks. These facilities typically lack the personnel and technology to perform high complexity molecular diagnostic tests. Since the test can be performed in these moderate complexity labs, patient results may be obtained readily to help speed therapeutic decisions. Simplexa tests, designed for use on the 3M Integrated Cycler, employ realtime polymerase chain reaction (PCR) technology to detect DNA or RNA in viruses, bacteria, and other analytes. Simplexa HSV 1 & 2 Direct showed strong performance in clinical studies, with 100% and 98% sensitivity for detection of HSV-1 and HSV-2 respectively. The test was CE-marked for distribution to more than 30 countries in Europe in November 2013.
Supplier: Focus Diagnostics, Inc
Website:
