Description
The care HPV Test is a signal-amplification, rapid batch diagnostic test for high-risk HPV DNA detection. The care HPV Test allows the qualitative detection of 14 high-risk types of HPV DNA in cervical and vaginal specimens in limited-resource settings.
A multi-center clinical study using the care HPV Test with the care HPV Test System was conducted with cervical specimens collected using the care Brush and care HPV Collection Medium from women (30–59 years) in a general screening population and outpatients clinics. A total of 1279 women were enrolled in this study, representing a relatively equal distribution across 3 hospitals; 1241 participants completed the study. The 3 study sites collected specimens from approximately 147 patients diagnosed with cervical cancer or precancerous lesions (CIN 2/3+), 162 patients with benign lesions (inflammation/mild cervical intraepithelial neoplasia, CIN 1) and 932 cases of normal control. Acetic acid staining was also performed for visual examination (VIA). Liquid-based cytology was performed at each hospital and the results recorded using the Bethesda Classification. The care HPV Test, the digene HC2 High-Risk HPV DNA Test and amplification of HPV nucleic acid using a PCR-based fluorescent detection kit were performed for each patient specimen. All care HPV testing was performed at room temperature (15–30°C). Test results were compared to the disease status of each patient. The concordance between the care HPV Test and digene HC2 High-Risk HPV DNA Test was 93.71%. The concordance between the care HPV Test versus PCR-based HPV detection was 90.89%. In studies comparing self-collected versus physician-collected specimens, the results of care HPV testing indicated reduced but similar sensitivity for CIN 2+: 70–83% for self-collected versus 82–96% for physician-collected. Specificity results were similar for CIN 2+ for both methods: 87–91% for self-collected versus 83–92% for physician-collected specimens. Studies indicate that the care HPV Test does not cross-react with microorganisms likely to be found in human cervical or vaginal specimens. The care HPV Test does not cross-react with human genomic DNA. There are no overlapping, cross-reactive DNA sequences in HIV, HBV, EBV, CMV, Adenovirus 2 and Neisseria meningitides. Substances that may be found in cervical or vaginal specimens (whole blood, douche, anti-fungal cream, contraceptive jelly and vaginal lubricant) were tested for impact on the performance of the care HPV Test. False-positive results were observed with anti-fungal cream, but no false positive results were observed with any of the other substances at any concentration tested.
The care HPV Test utilizes the same Hybrid Capture 2 (HC2) technology developed for QIAGEN digene HC2 High-Risk HPV DNA Test (HC2 Test). The care HPV Test detects the presence of the high-risk carcinogenic HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 using full genome probes complementary to HPV DNA, specific antibodies, signal amplification and chemiluminescent detection. The care HPV Test is used with the care HPV Test system to analyze HPV DNA high-risk groups in cervical and vaginal specimens collected with a care Brush and care HPV Collection Medium.
The care HPV Test and care HPV Test System detect the presence of 14 high-risk carcinogenic HPV 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 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 by the care HPV Test Luminometer. The results are automatically interpreted by the care HPV Test System and are displayed graphically on the care HPV Test Controller screen.
