Evaluation of a new point-of-care serologic assay for herpes simplex virus type 2 infection.

Herpes simplex virus type 2 infection is one of the most common sexually transmitted diseases. Because presentation is often atypical or subclinical, serologic testing is necessary for diagnosis, treatment, and counseling. In an urban clinic that specializes in the treatment of sexually transmitted disease, a new point-of-care rapid serologic test was compared with enzyme-linked immunosorbent assay or Western blot for the detection of herpes simplex virus type 2. With use of an enzyme-linked immunosorbent assay index cutoff value of 1.1, the rapid test was found to have a sensitivity of 97%, a specificity of 98%, a positive predictive value of 92%, and a negative predictive value of 99%. Increasing the cutoff index value to 3.5 increased the test sensitivity to 100%.