Multicenter clinical evaluation of the Du Pont Herpchek HSV ELISA, a new rapid diagnostic test for the direct detection of herpes simplex virus.
A new 4h rapid enzyme-immunoassay for direct detection of herpes simplex virus (HSV) antigen (Du Pont Herpchek) 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 Herpchek 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%.
Baker
D A
DA
Department of Obstetrics and Gynecology, State University of New York, Stony Brook 11794.
Pavan-Langston
D
D
Gonik
B
B
Milch
P O
PO
Dunkel
E C
EC
Berkowitz
A
A
Woodin
M B
MB
Philip
A
A
Vander-Mallie
R J
RJ
Bobrow
M N
MN
D000328:Adult; D000956:Antigens, Viral / Q000032:analysis; D002478:Cells, Cultured; D004797:Enzyme-Linked Immunosorbent Assay; D005069:Evaluation Studies as Topic; D015828:Eye Infections, Viral / Q000175:diagnosis; D005260:Female; D006561:Herpes Simplex / Q000175:diagnosis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D012749:Sexually Transmitted Diseases / Q000175:diagnosis; D018139:Simplexvirus / Q000302:isolation & purification*
D000956:Antigens, Viral; D011933:Reagent Kits, Diagnostic