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Clin. Vaccine Immunol. doi:10.1128/CVI.00218-07
Copyright (c) 2007, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Rapid, Sensitive and Specific Lateral-Flow Immunochromatographic Point-of-Care Device to Detect HSV-2 Specific Immunoglobulin G Antibodies in Serum and Whole Blood

Research and Development Department, Focus Diagnostics, Inc., Cypress, CA; Research and Development Department, BBInternational, Cardiff, UK

^* To whom correspondence should be addressed. Email: eladerman{at}focusdx.com.

	Abstract

Herpes simplex virus-2 (HSV-2) is a common human pathogen that can cause a variety of clinical manifestations in humans. In order to provide near-patient results to allow for faster counseling and treatment, a rapid point of care test that is accurate and simple to use is desirable. Here we describe the development and evaluation of a HSV-2 IgG specific antibody lateral flow immunochromatographic assay (LFIA) based on gold colloid nanoparticles. A total of 359 serum samples and 100 whole blood samples were tested in the newly developed HSV-2 LFIA. Serum results were compared with the HerpeSelect® HSV-2 enzyme-linked immunosorbent assay (ELISA) and whole blood samples compared to both ELISA and HerpeSelect® HSV 1 and 2 Immunoblot (IB). The sensitivity of the HSV-2 LFIA compared with the HerpeSelect ELISA was 100% (89/89), and the specificity was 97.3% (257/264). Cross-reactivity with HSV-1 IgG positive serum samples was observed in 2.6% (5/196), 2.9% (1/34) for Rubella and 6.2% (1/16) for EBV. No cross-reactivity in VZV or CMV IgG positive serum samples was observed. No interference was observed from bilirubin, triglycerides, albumin or hemoglobin spiked samples. Concordance of the LFIA results between capillary whole blood, EDTA and heparin venous whole blood and serum was 99% (99/100). In conclusion, the LFIA for HSV-2 IgG specific antibodies demonstrated excellent sensitivity, specificity, and concordance for both serum and whole blood samples when compared to both HSV-2 ELISA and Immunoblot (IB).