Infectious disease test kit 619029

acetic acidHPVclinical

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. CARE is a registered trademark of COOPERATIVE FOR ASSISTANCE AND RELIEF EVERYWHERE, INC. (“CARE”). CARE and the members and affiliates of CARE International are not affiliated with QIAGEN and do not sponsor, endorse, support, participate in or control the development, manufacture, use or sale of any QIAGEN product. Features Detection of 14 high-risk HPV types Convenient test results in 2.5 hours for possible same-day follow up Accurate, robust and accessible primary screening High clinical sensitivity and specificity Product Details The careHPV Test is a signal-amplification, rapid batch diagnostic test for high-risk HPV DNA detection. The careHPV Test allows the qualitative detection of 14 high-risk types of HPV DNA in cervical and vaginal specimens in limited-resource settings. Performance 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).