DuPont gets 510(k) for HSV test:
This article was originally published in Clinica
DuPont NEN is the first manufacturer to get US FDA 510(k) approval for a rapid herpes simplex ELISA. According to NEN's UK technical supervisor, Carole Staniford, the four-hour test has over 96% sensitivity and 100% specificity. The HerpChek kit costs £733 ($1,150) for a 96-well plate, reagents and 50 HerpTran specimen collection and transport packs.