New Sensitive and Specific Rapid HSV-2 Antibody Test

Background:
HSV-2 genital herpes is the most prevalent STI in the US today. Prior to September 2007, the only approved rapid HSV-2 antibody test was reasonably complicated to perform and not CLIA waivable.

Objective:
To describe the performance and uses of a new HSV-2 antibody test, HerpesSelect Express IgG, which received FDA approval on 21 September 2007.

Method:
A total of 359 serum samples and 100 whole blood samples were tested with the newly developed HerpesSelect Express IgG. Results were compared to the HerpesSelect HSV-2 ELISA for serum and for blood samples to the HerpesSelect ELISA and Immunoblot for HSV-1 and HSV-2. An HSV-2 inhibition test was used to resolve discordant results. In addition, sera positive for other viruses were selected for cross reactivity testing. The HerpesSelect Express IgG test was done by adding sample and buffer. Specific colored lines form within 15 minutes and the test and control lines on the test are then read.

Result:
The sensitivity of HerpesSelect Express IgG compared with the HerpesSelect ELISA was 100% (89/89) and the specificity was 97.3% (257/264). Cross reactivity with the HSV-1 IgG positive serum samples was 2.6% (5/196). Concordance of results between whole blood and serum was 99% (99/100).

Conclusion:
The HerpesSelect Express IgG demonstrated excellent sensitivity, specificity and concordance compared to type-specific ELISA and Immunoblot.

Implications:
This new test is simpler to use than the previously available rapid test and can be used in non-laboratory settings. It can facilitate earlier counseling and treatment and thus may lead to improved patient satisfaction as well as potential gains in preventing further transmission of HSV-2.