Evaluation of a fully automated glycoprotein G-2 based assay for the detection of HSV-2 specific IgG antibodies in serum and plasma

Background: Ranking after infections with Chlamydia trachomatis and human p apillomavirus, genital herpesvirus is the third most common sexually transm itted disease. The majority of recurrent genital herpes infections are caus ed by herpes simplex virus type-2 (HSV-2). Seroepidemiological studies on t he prevalence of HSV-2 specific Ige antibodies are especially important to study the impact of this infection among risk groups. Objective: To evaluate the sensitivity and specificity of the Cobas Core HS V-2 IgG specific assay (available for research use only), that can be run o n the Cobas Core fully automated immune-analyzer. Study design: The Cobas Core HSV-2 specific IgG EIA is based on macro-beads coated with affinity purified glycoprotein G-2 antigen from HSV-2 infected cells. The Cobas Core HSV-2 IgG specific assay was compared with the Chiro n rapid immunoblot assay (RIBA), the Gull enzyme-linked immunosorbent assay (EIA) and the Centocor EIA. The respective assays were tested, using 1219 serum samples, from 612 females and 607 males attending the outpatient clin ic for sexually transmitted diseases of the Erasmus Medical Center Rotterda m (EMCR). Results: The consensus value, obtained by a concordant result with three ou t of four assays, demonstrated 350 positive samples (28.7%), 851 negative s amples (69.8%) and 18 (1.5%) serum samples with a discordant result. The ov erall agreement of the Cobas Core HSV-2 EIA against the consensus value was 95.8% and the sensitivity and specificity proved to be 100 and 97.1% respe ctively. Conclusion: The results obtained with the Cobas Core HSV-2 EIA indicate tha t this is a useful, specific and sensitive assay for the detection of HSV-2 specific IgG antibodies in serum. The advantage of the Cubas Core HSV-2 EI A compared to the other assays, is that this assay can be performed in a fu lly automated process. (C) 1999 Elsevier Science B.V. All rights reserved.