title: Rapid, sensitive, and specific lateral-flow immunochromatographic point-of-care device for detection of herpes simplex virus type 2-specific immunoglobulin G antibodies in serum and whole blood.
abstract: 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.
authors.affiliation: Research and Development Department, Focus Diagnostics, Inc., Cypress, California, USA. bethlad@gmail.com
authors.forename: Elisabeth I
authors.initials: EI
authors.lastname: Laderman
authors.forename: Emma
authors.initials: E
authors.lastname: Whitworth
authors.forename: Erickson
authors.initials: E
authors.lastname: Dumaual
authors.forename: Mark
authors.initials: M
authors.lastname: Jones
authors.forename: Andrew
authors.initials: A
authors.lastname: Hudak
authors.forename: Wayne
authors.initials: W
authors.lastname: Hogrefe
authors.forename: Jim
authors.initials: J
authors.lastname: Carney
authors.forename: Jan
authors.initials: J
authors.lastname: Groen
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood* / Q000276:immunology; D002845:Chromatography / Q000379:methods*; D003429:Cross Reactions / Q000276:immunology; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D017979:Gold Colloid / Q000737:chemistry; D006558:Herpes Genitalis / Q000097:blood* / Q000276:immunology / Q000821:virology; D018258:Herpesvirus 2, Human / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D015151:Immunoblotting / Q000379:methods; D007074:Immunoglobulin G / Q000097:blood* / Q000276:immunology; D019095:Point-of-Care Systems; D011237:Predictive Value of Tests; D012372:ROC Curve; D012680:Sensitivity and Specificity; D044967:Serum / Q000276:immunology; D014762:Viral Interference
chemical_list: D000914:Antibodies, Viral; D017979:Gold Colloid; D007074:Immunoglobulin G