This assay aids in the diagnosis of sexually-transmitted HPV infection and is used for the triage of patients with an ASC-US Pap test result. The test provides a qualitative molecular detection of 13 different human papillomavirus high-risk types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68 without differentiation of the individual type.
A negative result does not exclude the possibility of an HPV infection since very low levels of infection or sampling error may cause a false-negative result.
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