Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test

Inclusion Criteria

• •Sample was taken from a lesion from an internal or external oral or genital site.
• •Sample was submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2.
• •The following information about the patient from which the sample was taken is available: presumptive diagnosis or signs and symptoms causing assay requisition; site of lesion; age at time of sample collection or date of birth, and sex.
• •Sample was collected in universal viral transport media, using a plastic shaft swab made of either polyester, cotton, rayon or Dacron.
• •There is sufficient residual sample to perform both test and reference assays.