Comparative performance of the Uni-Gold™ HSV-2 Rapid: a point-of-care HSV-2 diagnostic test in unselected sera from a reference laboratory.

Background: HSV-2 diagnosis is typically by viral culture, viral DNA amplification of lesion material or by serology in cases of subclinical presentation. These methods can be time consuming and expensive. The Uni-Gold™ HSV-2 Rapid is a fast, point-of-care diagnostic test that can be performed outside a full service laboratory.

Objective: To evaluate the ability of the Uni-Gold™ HSV-2 Rapid to correctly diagnose the presence or absence of anti-HSV-2 antibodies in patient serum samples in comparison to the University of Washington HSV Western blot (UWWB).

Study Design: Sera from 100 adult patients in the USA were tested for HSV-2 specific antibodies by Uni-Gold™ HSV-2 Rapid and results were compared to those of the UWWB to determine the test's sensitivity and specificity.

Results: Of 18 patients seropositive for HSV-2 by UWWB, 17 were correctly identified as such by the Uni-Gold™ HSV-2 Rapid. Of 76 patients who were seronegative for HSV-2 by UWWB, 75 were correctly identified by the rapid test. Six sera had indeterminate results by UWWB. Sensitivity for the Uni-Gold™ HSV-2 Rapid was 94% and specificity was 99%.

Conclusion: The Uni-Gold™ HSV-2 Rapid had high sensitivity and specificity in a small sample of unselected, adults seeking care in the Seattle, USA area. An accurate, near-person test allows immediate counseling directed toward symptom recognition, treatment, and practices that can limit the risk of HSV-2 transmission.