Products
The careHPV Test is an IVD product that can qualitatively detect 14 types of high-risk HPV DNA in cervical specimens, including 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. It cannot genotype these 14 types of high-risk HPV DNA. 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 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 specimens in limited-resource settings.
Performance
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 may cross-react with high-risk HPV types 73 and 82 and low-risk HPV types 71 and 81.
Principle
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 specimens collected with a careBrush and careHPV Collection Medium.
Procedure
The careHPV Test and careHPV 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 careHPV Test Luminometer. The results are automatically interpreted by the careHPV Test System and are displayed graphically on the careHPV Test Controller screen.
Applications
The use of the careHPV Test is indicated 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. The careHPV test is a cost-effective test 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.
Resources
Kit Handbooks (1)
Safety Data Sheets (1)
Certificates of Analysis (1)