The diagnostic method of the digene HC2 High-Risk HPV DNA Test, also called the digene HPV Test, allows rapid, standardized testing of HPV in virtually any laboratory setting. It employs specific RNA probes, hybridization, antibody capture, and signal amplification that utilizes qualitative chemiluminescent detection.
HPV Test, using Hybrid Capture 2 technology, provides an accurate, cost-effective, user-friendly method by achieving reliable and reducible detection, without the need for dedicated lab space.
Benefits of HC2:
- Full-length probe to ensure reliable sensitivity and specificity with no risk of deletions
- Unmatched cervical intraepithelial neoplasia (CIN) 2+ sensitivity
- Same-day results in a microplate test format
- High-throughput automation for handling increasing test volumes
- Minimal specimen preparation required for fast and efficient sample processing
- Signal amplification method with reduced cross-contamination risk
- Extensive clinical validation data available
Back to topHC2 technology superior for HPV DNA testing
For routine HPV diagnostics and clinical decision making, clinical sensitivity is critical. The HC2 technology fulfills this requirement better than any other method as outlined in multiple clinical validation studies.
In contrast, high analytical sensitivity may detect many transient HPV infections of clinical insignificance (see Figure 1). Cervical cancer screening methods require HPV detection correlating to disease and not to the sheer presence of the virus, since 90% of infections are cleared without consequences.
HC2 technology measures sensitivity versus defined clinical endpoints (CIN 3+/SCC) and ensures reporting of positive results only when risk of disease progression exists. QIAGEN’s digene
HPV Test has an excellent clinical sensitivity of up to 100% in adjunctive screening when combined with a Pap smear test [Mayrand, M.H. et al. (2007) N. Engl. J. Med. 357(16)
- Clinically validated cutoff of 5000 copies/ml
- Proven in multiple, extensive trials
- Ensures high negative predictive value
>Back to topHow HC2 technology works
The HC2 System is a signal-amplification assay that uses a technique combining antibody capture and chemiluminescent signal detction. The basic steps of the HC2 assays are outlined in Figure 2.