The digene HC2 HPV DNA Test is an in vitro microplate assay based on signal-amplified nucleic acid hybridization that uses chemiluminescence for the qualitative detection of 18 types of human papillomavirus (HPV) DNA in cervical specimens. The digene HC2 HPV DNA Test can differentiate between 2 HPV DNA groups, low-risk and high-risk types.
The digene HC2HPV DNA Test uses an RNA probe cocktail that detects 13 high-risk HPV types (16/18/31/33/35/39/45/51/52/56/58/59/68) and 5 low-risk types (6/11/42/43/44). To prevent false negatives caused by gene deletions, the digene HC2 HPV DNA Test uses full genome RNA probes complementary to HPV DNA, specific antibodies, signal amplification, and chemiluminescent detection.
The digene HC2 HPV DNA Test has been approved for use with the digene HC2 DNA Collection Device and ThinPrep Pap Test PreservCyt solution.
The digene HC2 High-Risk HPV DNA Test uses advanced Hybrid Capture 2 technology to directly detect HPV.
The digene HC2 HPV DNA Test detects the presence of 18 types of HPV 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 hyrbids. 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.
The digene HC2 HPV DNA Test is used to aid in the diagnosis of sexually transmitted HPV infections with HPV types 6, 11, 16, 18, 31, 33, 35, 39, 42, 43, 44, 45, 51, 52, 56, 58, 59, and 68.
The test is also used to screen patients with ASC-US (atypical squamous cells of undetermined significance) Pap test results to determine the need for referral to colposcopy. In women with low-grade squamous intraepithelial lesion (LSIL) or high-grade squamous intraepithelial (HSIL) Pap test results, prior to colposcopy, the digene HC2 HPV DNA Test result will assist in patient management risk assessment to determine the absence of high-grade disease.