Novel recombinant ELISA assays for determination of type-specific IgG antibodies against HSV-1 and HSV-2

The two novel Novagnost™ enzyme-linked immunosorbent assays (ELISA, Dade Behring) based on recombinant viral glycoprotein G were evaluated for determination of herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) IgG. ELISA and immunoblot procedures approved by the US Food and Drug Administration served as the reference for selecting different serum panels to be tested. The sensitivity and specificity of the novel assay for HSV-1 IgG were 93.1–98.0% and 99.3–100%, respectively, while the sensitivity and specificity of the novel assay for HSV-2 IgG were 100% and 94.6–97.6%, respectively. Using Kappa statistics, the Kappa indices were computed at 0.93–0.98 for the HSV-1 assays and 0.92–0.96 for the HSV-2 assays suggesting an almost perfect agreement between the novel ELISAs and the reference tests. In conclusion, the novel immunoassays for determination of HSV-1 or HSV-2 IgG can be recommended for the reliable type-specific diagnosis of HSV infections.