Genital herpes is an important public health problem with adverse social and medical consequences for both primary and recurrent episodes. Current diagnostic methods for HSV are not sufficiently sensitive, rapid or cost effective for routine clinical use. A sensitive method for detecting, typing and quantitating HSV is needed to improve the management of clinical and subclinical genital herpes and also recurrent herpes in immunocompromised individuals. Such a test could monitor effectiveness of antiviral drug therapies and development of drug resistance. A test capable of detecting HSV from cervical specimens could address predelivery diagnosis of asymptomatic infections in pregnant women. This application requires that the method give results within 6 hours and be robust enough for routine clinical use. In our Phase I SBIR, Digene's Hybrid Capture R II (HCII) signal- amplified DNA detection technology was adapted for the rapid and sensitive detection, typing and quantitation of HSV-1 and HSV-2 DNA from lesions. Further development will increase the sensitivity, specificity and ease of use of the tests; decrease time to results; provide quantitative output; demonstrate analytical and clinical performance of the tests in selected populations; and validate manufacturing and quality control procedures for the kit to meet these needs.
