Evaluation Of Four Commercial HSV-2 Type-specific IgG Antibody Test Kits And Their Use In Studies On Seroprevalence Of HSV-2 Infection

2.1 Evaluation of four commercial HSV-2 type-specific IgG antibody test kiteObjectives To compare the performance characteristics of four commercial ELISA kits for detection of HSV-2 type-specific IgG antibodies. Materials and Methods A total of 125 subjects, including 105 with genital ulcers, and 20 controls without any history of STDs were recruited from the STD clinic for detection of HSV-2 type-specific IgG antibody with different ELISA kits. Four kinds of commercially available ELISA kits, including Quida HSV-2 IgG ELISA (Aifulang Biochem Co. Ltd, Hangzhou), TORCH-HSV-2 IgG (Jingmei Biotech Co. Ltd, Shanghai), Captia^TM HSV-2 IgG (Trinity biotech, USA ) and HerpeSelect^TM 2 ELISA IgG (Focus technologies, USA), were used for evaluation. Western Blot assay was performed as a gold standard SPSS 10.0 and Medcalc 6.0 was used for statistic analysis. Results Compared to Westem Blot results, the sensitivity and specificity of the kits (Quida HSV-2 IgG ELISA, TORCH-HSV-2 IgG, Captia^TM HSV-2 IgG and HerpeSelect^TM 2 ELISA IgG) were 13.1% and 98.4%, 7.5% and 100%, 100% and 11.1 %, 87.7% and 96.7%, respectively. The areas under the ROC curve of three kits (Quida HSV-2 IgG ELISA, Captia^TM HSV-2 IgG and HerpeSelect^TM 2 ELISA IgG) were 0.885 (0.822-0.948), 0.825 (0.747-0.902), 0.974 (0.950-0.998), respectively. There was a significant difference in terms of the areas under the ROC curve between HerpeSelect^TM 2 ELISA IgG and Captia^TM HSV-2 IgG (p=0.00), and between HerpeSelect^TM 2 ELISA IgG and Quida HSV-2 IgG ELISA (p=0.003), but not any statistically significant difference between Captia^TM HSV-2 IgG and Quida HSV-2 IgG ELISA (p=0.171). Conclusion The performance of HerpeSelect^TM 2 ELISA IgG is the best among the four kits. The significant difference between the four kits also indicates that...