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 CE-IVD marked (see CE-IVD mark) for in vitro diagnostic use. The digene HC2 High-Risk HPV DNA Test shows sensitivity of approximately 93% and a negative predictive value of nearly 95% in women who have had Pap test results of LSIL (low-grade squamous intrapethelial lesion), HSIL (high-grade squamous intraepithelial lesion), or equivalent (see table). Clinical sensitivity and specificity for the determination of high-grade disease Referral Pap LSIL or HSIL progression to HSIL disease + – Total High-Risk HPV probe result + 89 140 229 – 7 91 98 Total 96 231 327 A patient population of women (N=702) enrolled in a multicenter study, and 327 met the study criteria of Pap smear results ≥ASC-US (atypical cells of undetermined significance), with adequate information available; 96 of these had a final disaese status of HSIL or greater. Exfoliated cervical cell specimes were collected at the time of colposcopy, and placed into STM or rinsed in PreservCyt Solution.The specimens were then tested with the digene HC2 High-Risk HPV DNA Test, and the results were compared to the disease status determed by histologic evaluation. However, when histology was negative or in the absence of a histology result, the disease status was determined by cytology at the time of colposcopic examination. Test results were compared to disease status to asses the test's sensitive, specificity, and negative and positive predictive value for detecting high-grade cervical neoplasia. Due to the similarities between the digene HC2 High-Risk HPV DNA Test performance with the STM and PreservCyt media, assay performance is presented only for PreservCyt samples. Sensitivity [TP/(TP+FN)] = 92.7% (89/96); 95% CI = 85.6 to 97.0. Specificity [TN/(TN+FP)] = 39.4% (91/231); 95% CI = 33.1 to 46.0. Disease prevalence for referral LSIL to final HSIL = 21.4%; disease prevalence for referral HSIL to final HSIL = 46.6%. 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 Specimen Transport Medium, and PreservCyt Solution (Hologic). 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 Hybrid Capture 2 technology to detect HPV. It is the most widely accepted HPV test, providing 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.
