Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects

Inclusion Criteria: * The subject has at least 1 active lesion (lesion with exudates and cellular material; eg, vesicle, ulcer) that is suspected to be caused by HSV (as determined by the clinician) * The subject and/or legally authorized representative is willing and able to provide consent prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board-approved waiver for parental consent for minors) Exclusion Criteria: * The subject has only HSV lesions without exudates and cellular material * The subject used a topical or oral antiviral medication used to treat HSV within 21 days of enrollment * Subject already participated in this study * Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the study * Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled in the study