Digene Hybrid Capture
Digene Hybrid Capture 2 (HC2) HPV DNA Testing from ThinPrep Pap Tests
- In March of 2000, The Food and Drug Administration (FDA) approved the use of Digene HC2 HPV DNA testing as a follow-up test for women with abnormal Pap tests.
- In September of 2002, the ASCCP Consensus Guidelines for the Management of Women with Cervical Cytological Abnormalities listed Digene HC2 HPV DNA testing as the preferred management protocol for women with a cytologic diagnosis of ASC-US as a triage prior to colposcopy.
- In April of 2003, the FDA cleared the use of Digene HC2 as a screening test to be used in conjunction with a liquid-based Pap test for women over the age of 30.
- Fletcher Allen Health Care offers three options for ordering Digene HC2 HPV DNA testing; two prospectively and one retrospectively. For prospective ordering simply circle the appropriate option on the patient requisition when submitting the ThinPrep Pap test (as seen below).
| DIGENE HPV TESTING | ||
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Yes | No |
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Yes | No |
Retrospectively, Digene HPV testing may be done up to 21 days post collection of the ThinPrep sample. Add on testing is allowed within this time frame, but requires a new requisition (with the appropriate clinical diagnosis code) be faxed to Cytopathology to request HPV testing.
Digene testing requires 4ml of residual sample after the Pap testing has been completed. In our experience at FAHC approximately 5% of HPV requests cannot be completed due to insufficient cellular material.
