MeltPro® High Risk HPV Genotyping Assay is a qualitative in vitro test used for HPV genotyping and cervical cancer screening using cervical cells collected by swab, TCT or LCT. This test utilizes Polymerase Chain Reaction (PCR) for DNA amplification and nucleic acid hybridization for the detection of high-risk HPV types in one reaction. This test specifically identifies 14 high-risk HPV types,
including HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-56, HPV-58, HPV-59, HPV-66, and HPV-68. The test is indicated 1) to screen patients age 21 and older with ASU-US (atypical squamous cells of undetermined
significance) cervical cytology test results to determine the need for referral to colposcopy, and assess the presence of high-risk HPV, to guide patient management together with the physician’s assessment of cytology history, other risk factors, and
professional guidelines; 2) to use with cervical cytology to adjunctively screen to assess the presence of high risk HPV types in women age 30 and older, considering other risk factors such as cytology history to guide patient management.