Kit Distinguishes Between HSV-1 and HSV-2 in Vaginal Specimens

Qualitative detection of Herpes simplex virus (HSV) types 1 or 2 is based on the polymerase chain reaction (PCR). Results are available in approximately four hours.

The HSV 1&2 kit utilizes MultiCode-RTx technology based on the company's novel synthetic DNA base pair (nucleotide): isoC:isoG. Not only are the isoC and isoG specific to each other, they are recognized by the enzyme used for PCR. This probe free chemistry provides significant ease-of-use and workflow advantages.

MultiCode-RTx uses PCR to amplify and then detect target DNA sequences. If a specific target sequence is present, PCR amplification will occur. During the amplification process, MultiCode directs the PCR enzyme to insert a fluorescence quencher directly opposite a reporter dye resulting in a decrease of fluorescence with every PCR cycle. The decrease is easily monitored by real-time PCR instruments.

EraGen Biosciences Inc. (Madison, WI, USA) announced that the U.S. Food and Drug Administration (FDA; Silver Springs, MD, USA) has granted 510(k) market clearance for the company's MultiCode-RTx HSV 1&2 Kit. The assay is not intended to be used for male penile specimens, for prenatal screening, or for females under the age of 18 years.

"EraGen's HSV 1&2 kit is the first FDA-cleared, molecular test for the Herpes simplex virus. It has considerable advantages over the traditional testing methodologies used today for the detection and typing of the virus in symptomatic women,” said Irene Hrusovsky, M.D., president and chief executive of EraGen.

Herpes simplex viruses cause oral and genital herpes infections. In immunocompromised individuals and infants, they can cause central nervous system disorders, blindness, liver disease, brain infections, and other illnesses.

EraGen Biosciences develops, manufactures, and markets innovative molecular diagnostic products. The company's in-market and pipeline products, based on MultiCode platform chemistry, are the next generation of DNA- and RNA-based testing for the early detection of infectious diseases and genetic conditions.

Related Links:
EraGen Biosciences Inc.
U.S. Food and Drug Administration