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. Exclusion Criteria: * Sample leaked during shipment or storage prior to assay. * Sample has undergone more than 1 freeze-thaw cycle before testing; * Sample eluent is not clear after centrifugation (refer to section 6.3.1). * Sample ID is missing or ambiguous. * Sample is collected using alginate calcium swab. * Sample handling and storage requirement in section 5.4 not followed