BACKGROUND: Serologic assays that identify herpes simplex type 2 (HSV-2) type-specific antibodies have been commercially available for more than a decade. Greater acceptance of these tests is hindered by uncertainty regarding their performance in real-world clinical settings. OBJECTIVES: The primary objective was to compare the test characteristics of the Focus HerpeSelect Express Assay (EA) versus the Focus HerpeSelect enzyme linked immunoassay (ELISA) for detection of HSV-2 type-specific antibodies among pregnant women enrolled from 3 geographic sites with varying prevalences of HSV-2 infection. A second objective was to evaluate the performance of a HSV-2 testing strategy in which EA screens and ELISA confirms HSV-2 serodiagnosis. STUDY DESIGN: We enrolled 399 pregnant women from Atlanta, GA, Moorestown, NJ, and Pittsburgh, PA into this cross-sectional investigation. Capillary whole blood was obtained from study participants, and evaluated for the presence of type-specific HSV-2 antibodies using the EA. Serum samples were also obtained from all study participants for subsequent identification of HSV-2 type-specific antibodies using both ELISA and the Focus Immunoblot assays. RESULTS: We observed 96.2% agreement between results obtained with EA and ELISA. Overall, when compared to ELISA results, the sensitivity of EA for detection of HSV-2 type-specific antibodies was 94.2% and the specificity was 97.1%. Using Immunoblot results as our standard for performance calculations, the positive predictive value (PPV) of HSV-2 serodiagnosis increased from 91.7% to 98.2% when ELISA was used to confirm EA testing. CONCLUSIONS: EA provides similar results to ELISA for the identification of HSV-2 type-specific antibodies among pregnant women. As use of the point-of-care (POC) EA in conjunction with confirmatory ELISA testing improves the PPV of HSV-2 serodiagnosis compared to the use of EA or ELISA testing alone, validation of this diagnostic algorithm in other at-risk populations may be warranted.
BACKGROUND: Serologic assays that identify herpes simplex type 2 (HSV-2) type-specific antibodies have been commercially available for more than a decade. Greater acceptance of these tests is hindered by uncertainty regarding their performance in real-world clinical settings. OBJECTIVES: The primary objective was to compare the test characteristics of the Focus HerpeSelect Express Assay (EA) versus the Focus HerpeSelect enzyme linked immunoassay (ELISA) for detection of HSV-2 type-specific antibodies among pregnant women enrolled from 3 geographic sites with varying prevalences of HSV-2 infection. A second objective was to evaluate the performance of a HSV-2 testing strategy in which EA screens and ELISA confirms HSV-2 serodiagnosis. STUDY DESIGN: We enrolled 399 pregnant women from Atlanta, GA, Moorestown, NJ, and Pittsburgh, PA into this cross-sectional investigation. Capillary whole blood was obtained from study participants, and evaluated for the presence of type-specific HSV-2 antibodies using the EA. Serum samples were also obtained from all study participants for subsequent identification of HSV-2 type-specific antibodies using both ELISA and the Focus Immunoblot assays. RESULTS: We observed 96.2% agreement between results obtained with EA and ELISA. Overall, when compared to ELISA results, the sensitivity of EA for detection of HSV-2 type-specific antibodies was 94.2% and the specificity was 97.1%. Using Immunoblot results as our standard for performance calculations, the positive predictive value (PPV) of HSV-2 serodiagnosis increased from 91.7% to 98.2% when ELISA was used to confirm EA testing. CONCLUSIONS: EA provides similar results to ELISA for the identification of HSV-2 type-specific antibodies among pregnant women. As use of the point-of-care (POC) EA in conjunction with confirmatory ELISA testing improves the PPV of HSV-2 serodiagnosis compared to the use of EA or ELISA testing alone, validation of this diagnostic algorithm in other at-risk populations may be warranted.
Authors: Hayley D Mark; Joy P Nanda; Jessica Roberts; Anne Rompalo; Johan H Melendez; Jonathan Zenilman Journal: Sex Transm Dis Date: 2007-09 Impact factor: 2.830
Authors: P Wutzler; H W Doerr; I Färber; U Eichhorn; B Helbig; A Sauerbrei; A Brandstädt; H F Rabenau Journal: J Med Virol Date: 2000-06 Impact factor: 2.327
Authors: Kevin A Stoner; Seth D Reighard; Rodolfo D Vicetti Miguel; Douglas Landsittel; Lisa A Cosentino; Jeffrey A Kant; Thomas L Cherpes Journal: J Obstet Gynaecol Res Date: 2011-12-05 Impact factor: 1.730