Cat. No. / ID: 614035
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.
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.
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.