Description
The digene HC2 High-Risk HPV DNA Test is an in vitro nucleic acid hybridization assay with signal amplification and chemiluminescence for the qualitative detection of 13 types of human papillomavirus (HPV) in cervical specimens. The test is suitable for high- or low-volume testing.
The digene HC2 High-Risk HPV DNA Test is FDA-approved for in vitro diagnostic use (see IVD mark). Using Hybrid Capture 2 technology for HPV testing offers the following benefits when compared with PCR for HPV testing: Standardized method Clinically relevant sensitivity (figure HC2 vs. PCR) Reliability — 10 million tests/year worldwide Less risk of false negatives due to inhibition
The digene HC2 High-Risk HPV DNA Test detects the presence of 13 high-risk HPV types (16/18/31/33/35/39/45/51/52/56/58/59/68, which are carcinogenic) using full genome probes complementary to HPV DNA, specific antibodies, signal amplification, and chemiluminescent detection. It analyzes HPV DNA high-risk groups in cervical specimens. The digene HC2 High-Risk HPV DNA Test has been approved for use with the digene HC2 DNA Collection Device, digene HC2 Sample Conversion Kit, digene Cervical Sampler, digene Specimen Transport Medium, and PreservCyt Solution (Hologic), depending on country regulations. Automated options for the digene HC2 High-Risk HPV DNA Test include the Rapid Capture System (for high-volume sample throughput testing); guidelines vary among countries.
The digene HC2 High-Risk HPV DNA Test uses advanced, Hybrid Capture 2 technology to directly detect HPV. It is the most widely accepted HPV test, providing extensive validation in conjunction with Pap in clinical studies. The digene HC2 High-Risk HPV DNA Test detects the presence of 13 high-risk types using full genome RNA probes complementary to the HPV DNA, specific antibodies, and chemiluminescent detection. The target DNA combines with specific RNA probes, creating RNA:DNA hybrids. Then, the RNA:DNA hybrids are captured onto a solid phase coated with universal capture antibodies specific for RNA:DNA hybrids. The specimen matrix is then washed from the captured hybrids to remove inhibitors. During the signal amplification, captured RNA:DNA hybrids are detected with multiple antibodies conjugated to alkaline phosphatase. The signal resulting from the chemiluminescent reaction is read and the results are automatically interpreted.
