Inaccuracy of certain commercial enzyme immunoassays in diagnosing genital infections with herpes simplex virus types 1 or 2

Abstract

Type-specific serologic results may be inaccurate if not based on glycoprotein G (gG). Commercial tests based on crude antigen (Zeus Scientific, Raritan, NJ; Wampole Laboratories, Cranbury, NJ; DiaSorin, Stillwater, MN) and one using gG-1 and gG-2 (Focus Technologies, Cypress, CA) were compared with Western blot on serum samples from patients with culture-documented first symptomatic episodes of genital herpes simplex virus (HSV) type 1 (n = 17) or HSV-2 (n = 49) infection or recurrent genital episodes (HSV-1, 30; HSV-2, 49). Concordance with Western blot results was 56% for Zeus, 63% for Wampole, 52% to 54% for DiaSorin, and 83% for Focus. Sensitivity and specificity, respectively, for HSV-1 were 77% and 53% (Zeus), 91% and 35% (Wampole), 98% and 8% (DiaSorin), 94% and 70% (DiaSorin predominant antibody), and 83% and 90% (Focus); for HSV-2 they were 88% and 81% (Zeus), 92% and 83% (Wampole), 96% and 54% (DiaSorin), 38% and 98% (DiaSorin predominant antibody), and 98% and 96% (Focus). Type-specific serologic testing for HSV should be performed with gG-based tests for accurate diagnosis of symptomatic genital herpes.