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 papillomavirus, genital herpesvirus is the third most common sexually transmitted disease. The majority of recurrent genital herpes infections are caused by herpes simplex virus type-2 (HSV-2). Seroepidemiological studies on the prevalence of HSV-2 specific IgG 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 HSV-2 IgG specific assay (available for research use only), that can be run on the Cobas Core fully automated immuno-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 Chiron 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 clinic for sexually transmitted diseases of the Erasmus Medical Center Rotterdam (EMCR).

RESULTS

The consensus value, obtained by a concordant result with three out of four assays, demonstrated 350 positive samples (28.7%), 851 negative samples (69.8%) and 18 (1.5%) serum samples with a discordant result. The overall 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% respectively.

CONCLUSION

The results obtained with the Cobas Core HSV-2 EIA indicate that this is a useful, specific and sensitive assay for the detection of HSV-2 specific IgG antibodies in serum. The advantage of the Cobas Core HVS-2 EIA compared to the other assays, is that this assay can be performed in a fully automated process.