Multicenter Clinical Evaluation of the Du Pont HERPCHEKTM HSV Elisa, a New Rapid Diagnostic Test for the Direct Detection of Herpes Simplex Virus

Abstract
A new 4h rapid enzyme — immunoassay for direct detection of herpes simplex virus (HSV) antigen (Du Pont HERPCHEKTM) was evaluated with 743 clinical samples collected at obstetrics and gynecology (OB/GYN), sexually transmitted diseases (STD), and ophthalmology clinics. The sensitivity and specificity of HERPCHEKTM was 98.0% and 98.4% respectively compared to virus isolation in cell culture. Confirmatory blocking ELISA tests, clinical history and follow up indicate that the true specificity of the test is 100%.