Article Text
Abstract
Background HSV infections during pregnancy are generally asymptomatic and associated with high rate of neonatal morbidity and death. Differential serologic diagnosis of HSV infections in pregnancy is important for the correct assessment of the infection status. The aim of this study was to evaluate the performance of Roche Elecsys® assays for the type specific determination of HSV-1 and HSV-2 IgG antibodies.
Methods A total of 800 samples obtained from sexually active adults (n = 300), pregnant women (n = 400) and herpes infection suspected patients(n = 100) were analysed using Roche Elecsys® HSV-1 and HSV-2 assays and commercially available Focus Diagnostics HerpeSelect, Radim HERPES S.V and Diasorin LIAISON type specific ELISA assays.
A commercially available Western Blot assay was used for the resolution of the discrepant results.
For further confirmation of the type specific detection performance of the Elecsys® HSV-1 and HSV-2 assays 310 potentially cross reactive samples for HSV-2 and 123 samples for HSV-1 were analysed.
Results The Elecsys® HSV-1 IgG assay showed a relative sensitivity of 95.6 to 100%. The relative specificity was between 97.6 and 100%. The Elecsys® HSV-2 IgG assay showed a relative sensitivity of 92.6 to 100%. The relative specificity was between 98.7 and 100%. These assays exhibits excellent differentiation between HSV-1 and HSV-2 infections with no cross reactivity to other herpes viruses like CMV, VZV or EBV.
Conclusion The results obtained with the type specific Roche Elecsys® HSV-1 and HSV-2 assays indicate that these assays are useful, specific and sensitive for the differential determination of HSV-1 and HSV-2 IgG antibodies in serum or plasma samples. The advantage of the Roche Elecsys® assays compared to ELISA based assays, is that these assays are rapid and can be performed in a fully automated process.
- Evaluation
- HSV IgG
- type specific