Herpes simplex virus type 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 an HSV-2 immunoglobulin G (IgG)-specific antibody lateral-flow immunochromatographic assay (LFIA) based on colloidal gold 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 to those from the HerpeSelect HSV-2 enzyme-linked immunosorbent assay (ELISA), and whole-blood sample results were compared to those of both ELISA and HerpeSelect HSV-1 and -2 immunoblotting (IB). The sensitivity of the HSV-2 LFIA compared to that of 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) of samples, 2.9% (1/34) for rubella virus, and 6.2% (1/16) for Epstein-Barr virus. No cross-reactivity in varicella-zoster virus or cytomegalovirus IgG-positive serum samples was observed. No interference was observed from bilirubin-, triglyceride-, albumin-, or hemoglobin-spiked samples. The concordance of the LFIA results between capillary whole blood, EDTA-treated venous whole blood, heparin-treated 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 compared to the sensitivity, specificity, and concordance of both HSV-2 ELISA and IB.Herpes simplex virus (HSV) is a common human pathogen found worldwide that causes a variety of diseases (6). HSV has been characterized into two different serotypes: HSV type 1 (HSV-1) generally is associated with infections in the tongue, mouth, lips, pharynx, and eyes, whereas HSV-2 primarily is associated with genital and neonatal infections (6). HSV infects neonates, children, and adults; by the age of 40, more than 90% of the adult population demonstrates antibodies to HSV-1 (6). In the United States, most young sexually active adults with genital ulcers have genital herpes (8).Primary HSV-2 infections usually are transmitted through sexual contact. HSV transmission can result from direct contact with infected secretions from symptomatic or asymptomatic individuals (19). The classic presentation is herpes genitalis, an infection characterized by lesions in the genital area, and it may be accompanied by fever, inguinal lymphadenopathy, and dysuria. Previous studies demonstrated that HSV-2 causes approximately 85% of symptomatic primary genital HSV cases, with HSV-1 infections causing the remainder (1). However, more recently it has been shown that approximately 30% of primary genital herpes infections presently are associated with 13,22). Despite the increase in genital herpes cases due to HSV-1, the HSV-1 recurren...

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