A positive result (Detected) indicates the presence of DNA from one or more of the following high risk HPV types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68. This assay does not genotype the virus. A negative result does not exclude the possibility of infection with a high risk HPV type. False negative results may be due to low levels of HPV infected cells, inhibitory substances, inappropriate or inadequate sampling, or insufficient cellular material. Inadequate specimen collection, processing and storage may invalidate test results.
This test should not be used as the only criterion to form a clinical conclusion; instead, results should be correlated with other test results, patient symptoms and clinical presentation.
This test is approved by the U.S. Food and Drug Administration.