Type-Specific Antibody Detection of Herpes Simplex Virus Types 1&2 (HSV-1&2) in Fingerstick Blood at Point-Of-Care Sites by a Rapid and Sensitive Lateral Flow Immunochromatographic Assay

Following the initial infection, herpes simplex viruses type 1 (HSV-1) and type 2 (HSV-2) establish latency in sensory nerve ganglia. The viruses can later reactivate, producing recurrent lesions such as painful vesicles or ulcers. HSV-1 is most often associated with oral herpes (cold sores), whereas HSV-2 is more commonly linked to genital herpes. Serologic IgG tests can be used to determine if a person has antibodies to HSV-1 or HSV-2 from past infection. In this paper, we describe the development and performance evaluation of an antibody based lateral flow immunochromatographic assay (LFA) device for the detection and differentiation between HSV-1&2 IgG antibody in fingerstick blood. Analytical and clinical analyses were performed to compare the performance characteristics of the HSV-1&2 IgG LFA (VIZIHSV™) with Western Blot.VIZIHSV™ results from 373 subjects seeking STI care and 267 pregnant women at four clinical sites were compared with results obtained by testing serum samples obtained from the same study participants with Western Blot. When compared to Western Blot, the Positive Predictive Agreement (PPA) and Negative Predictive Agreement (NPA) in individuals seeking care for STIs was 94.6% (95% CI: 91.4-96.6%) and 94.9% (95% CI: 87.5-98.0%), respectively. PPA for HSV-2 in this group was 99.0%, 95% CI (96.3%,99.7%) and the NPA was 91.6%, 95% CI (86.6%, 94.8%). Performance in pregnant women was similar to that in the STI-care-seeking group with an HSV-1 PPA of 90.4% (95% CI: 85.0-94.0%) and NPA of 96.0% (95% CI: 90.2-98.4%). PPA for HSV-2 in pregnant women was 91.3% (95% CI: 79.7- 96.6%) and NPA was 91.7% (95% CI: 87.3-94.7).Results from the clinical study also showed that 29% of the 373 subjects seeking STI care and 66.3% of pregnant women did not indicate a past history of HSV-1 or HSV-2 infection, indicating that HSV-1&2 IgG LFA type-specific serology will enhance the ability to detect past infection and make the diagnosis and guide clinical management in select patients.VIZIHSV™ has been demonstrated to be simple and sufficiently robust for use in CLIA-waived point-of-care (POC) facilities by untrained healthcare professionals and to detect and differentiate between HSV1&2 IgG antibody from fingerstick blood in 30 min. Therefore, this test provides a fast, reliable, and highly sensitive method to detect IgG antibody to HSV-1 and/or HSV-2 viral infection.