- Cervical Biopsy
- LEEP
- Endometrial Biopsy
- D & C Curettage
- POC
- Breast
- HPV, Gonorrhea and Chlamydia Testing
Digene High-Risk HPV HC2 DNA Test
- Gold standard in HPV testing
- Detection of 13 high-risk HPV types
- Highest clinical sensitivity proven by extensive clinical validation
- Standardized, objective results
- FDA-approved and CE-marked HPV test
The digene High-Risk HPV HC2 DNA Test is an in vitro nucleic acid hybridization assay that utilizes antibody capture and qualitative chemiluminescent signal detection of HPV types based on signal amplification. The test is suitable for high- or low-volume testing.
Applications
High-risk DNA DetectionSpecial Instructions Specimen must be submitted using HPV collection kit (supplied by Digene), or liquidbased cytology preservative. The digene High-Risk HPV HC2 DNA Test has been approved for use with the digene DNA Collection Device, digene Cervical Sampler, digene Specimen Transport Medium, and Cytyc ThinPrep Pap Test PreservCyt Solution.
Specimen Cervical brush sample in Digene DNA collection kit or liquid-based cytology preservative, cervical biopsy.
Minimum Volume (required only for liquid based collection methods): For cells collected in liquid-based cytology preservative, at least 4 mL of preservative must be submitted for Cytyc ThinPrep® specimens. For TriPath SurePath® specimens,that have been processed for a Pap, add 2 mL CytoRich® fi xative to the 0.8 mL cellular concentrate fraction. Biopsy: 2 mm.
Use: This assay aids in the diagnosis of sexually transmitted HPV infection and for the triage of patients with an ASCUS Pap test result. The test provides in cervical specimens 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.
Limitations: A negative result does not exclude the possibility of an HPV infection since very low levels of infection or sampling error may produce a false-negative result.
Storage: Maintain Digene HPV collection kit at room temperature for up to two weeks, and refrigerated for up to three weeks.