This assay is to be used only for patients with a clinical history and symptoms consistent with HSV infection and must be interpreted in the context of the clinical picture. This test should not be used to screen asymptomatic patients. Optimal performance of the test requires adequate specimen collection, transport and handling. HSV viability and/or infectivity cannot be inferred from a positive test result since target DNA may persist in the absence of infectious virus. A negative test does not rule out infection. There is a risk of false negative results due to the presence of sequence variants in the targets of the assay.