# digene Hybrid Capture 2 (hc2) High-Risk HPV DNA Test

Source: https://onco.cc/drugs/digene-hc2-hpv/  
OnCo record `digene-hc2-hpv` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Qiagen's hybrid capture HPV test, approved by the FDA in 2003 for use with the Pap test in women 30 and older and for sorting out borderline Pap results.

## Summary

The hybrid capture HPV test sits under PMA P890064, first approved on 11 March 1991 as the ViraType HPV DNA typing kit (now held by Qiagen Gaithersburg). The Digene Hybrid Capture 2 (hc2) High-Risk HPV DNA Test was approved on 31 March 2003 (supplement S009) for two uses: to screen patients with ASCUS Pap results to decide on referral to colposcopy, and "in women 30 years and older" to be used "with Pap to adjunctively screen to assess the presence or absence of high-risk HPV types".

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-04
- Also known as: Hybrid Capture 2; hc2; Digene HPV test; HCII
- Tags: test; screening-test
- Brand: hc2 High-Risk HPV DNA Test
- Modality: HPV DNA test (hybrid capture, signal amplification) for cervical screening
- Mechanism: HPV DNA in the sample forms RNA:DNA hybrids with the test's probes; the hybrids are captured on a microtitre plate and detected (the capture step described in supplement S006).
- Approvals: US 1991: ViraType HPV DNA typing kit, the original approval of PMA P890064 under which the hybrid capture tests followed; US 2003: High-risk HPV DNA test on cervical specimens: ASCUS triage and adjunctive screening with the Pap test in women 30 and older (PMA P890064/S009)

## Notes

- What a result means: a positive HPV test means a high-risk virus type was found, not that there is a precancer or cancer; it leads to triage (genotyping, cytology or a dual stain) or colposcopy according to the screening programme's guideline.

## Sources

- FDA PMA P890064: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P890064

## Connected records

- drugs: [Aptima HPV Assay and Aptima HPV 16 18/45 Genotype Assay](https://onco.cc/drugs/aptima-hpv/), [cobas HPV test (Roche)](https://onco.cc/drugs/cobas-hpv/)
- collections: [FDA medical device databases (PMA, 510(k), De Novo)](https://onco.cc/collections/fda-device-databases/)
- cancers: [Cervical cancer](https://onco.cc/cancers/cervical/)
- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/), [Early Detection & Screening](https://onco.cc/fronts/early-detection/)
- technologies: [HPV DNA testing and self-sampling](https://onco.cc/technologies/hpv-testing/)
- companies: [QIAGEN](https://onco.cc/companies/qiagen/)
- terms: [Cervical precancer (CIN, HSIL/LSIL)](https://onco.cc/terms/cin-hsil/), [Screening](https://onco.cc/terms/screening/)

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