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.