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