Cat. No. / ID: 614015
A multi-center clinical study using the careHPV Test with the careHPV Test System was conducted with cervical specimens collected using the careBrush and careHPV 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 careHPV 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 careHPV testing was performed at room temperature (15–30°C). Test results were compared to the disease status of each patient. The concordance between the careHPV Test and digene HC2 High-Risk HPV DNA Test was 93.71%. The concordance between the careHPV Test versus PCR-based HPV detection was 90.89%.
In studies comparing self-collected versus physician-collected specimens, the results of careHPV 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 careHPV Test does not cross-react with microorganisms likely to be found in human cervical or vaginal specimens. The careHPV 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 careHPV 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 careHPV Test utilizes the same Hybrid Capture 2 (HC2) technology developed for QIAGEN digene HC2 High-Risk HPV DNA Test (HC2 Test).
The careHPV 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 careHPV Test is used with the careHPV Test system to analyze HPV DNA high-risk groups in cervical and vaginal specimens collected with a careBrush and careHPV Collection Medium.
The use of the careHPV Test is indicated as a primary screening test in women 30 years and older to detect high-risk HPV infection. The HPV types detected by the test are the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. High-risk HPV infection is a risk factor for developing high-grade cervical intraepithelial neoplasia (CIN 2/3+). Cervical specimens for testing may be collected by physicians or trained medical professionals. Vaginal specimens may be self-collected under the guidance of a medical professional. The careHPV test is a cost-effective primary screening tool for cervical cancer in developing countries.
The careHPV Training Panel is used to demonstrate the operation and maintenance of the careHPV Test System, conduct a detailed overview of the careHPV Test procedure, demonstrate each step of the careHPV Test and perform validation of trainee test performance.