FDA Clears First HSV-1, 2 Detection Test
Quest Diagnostics announced that the FDA has cleared Focus Diagnostics' new Simplexa HSV 1 & 2 Direct molecular test with a CLIA moderate complexity categorization.
Simplexa is the first FDA-cleared molecular test 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 utilizes a proprietary process to produce results within an hour after providing a specimen without requiring nucleic acid extraction.
Simplexa tests employ real-time polymerase chain reaction (PCR) technology to detect DNA or RNA in viruses, bacteria, and other analytes. In clinical studies, Simplexa HSV 1 & 2 Direct showed 100% and 98% sensitivity for the detection of HSV-1 and HSV-2, respectively.
Simplexa HSV 1 & 2 Direct molecular test is designed for use on the 3M Integrated Cycler and is now available for purchase.
For more information call (800) 838-4548 or visit FocusDx.com.