Herpes Simplex Virus Assay, Sample-to-Answer Instrument Get FDA Clearance

Herpes simplex virus 2 (HSV2) is a widespread herpes virus, usually sexually transmitted and responsible for genital herpes. Herpes simplex virus 1 (HSV1) is a common virus life-long established in the peripheral nervous system.

A sample-to-results diagnostic instrument and an assay to detect and differentiate herpes simplex viruses 1 and 2 have received 510(k) clearance. The instrument and assay are now commercially available in the USA. The instrument integrates extraction, amplification, and results interpretation, and is also an open platform compatible with commonly used fluorescent probes. It contains 12 independent thermal cyclers that can run different polymerase chain reaction (PCR) profiles in each run, with six detection channels for multiplex detection. It can also run multiple different assays from a single sample tube.

The ELITe MGB HSV 1&2 Assay (EliTech Group, South Logan, UT, USA) is cleared for use by the US Food and Drug Administration (FDA, Silver Springs, MD, USA) on swab specimens from cutaneous or mucocutaneous lesions in symptomatic patients with cold sores or genital herpes. The diagnostic instrument, called the Elite InGenius, is a fully automated benchtop instrument that performs real-time PCR-based testing on 12 tests in a run, requiring two minutes of hands-on time per sample.

The Elite InGenius instrument can be used in various operational modes, including extraction-only, amplification-only, or full-processing extraction, amplification, and result analysis with melt curve analysis capability. It was introduced as a CE-IVD marked instrument in 2015 with a core menu of transplant monitoring assays. The firm also currently markets a menu of CE-marked molecular diagnostics kits for detecting hospital-acquired infections, sexually transmitted diseases, respiratory infections, bacterial and viral meningitis. In addition, the EliTech Group manufactures and distributes diagnostic products for clinical chemistry, microbiology, and molecular biology.