This diagnostic kit is an in vitro nucleic acid amplification test for the detection of high-risk human papillomavirus (type 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68) present in exfoliated cells from females’ cervix. The test results can be used for diagnosis of a high-risk HPV infection.
The diagnostic kit uses a nucleic acid lysis buffer to allow rapid lysis and release of HPV-DNA. By applying real-time fluorescence quantitative PCR technology, this test utilizes pairs of specific primers and specific probes which are designed to target at conserved sequences of the above-mentioned 15 HPV-DNA types, accompanied with PCR mix, to achieve fast detection of the 15 types of HPV-DNA through fluorescent signal changes.
The PCR detection system uses UNG enzyme + dUTP contamination-proof system to fully degrade possible unwanted side-products in order to avoid a false positive result.
The PCR detection system uses a positive control to monitor β-globulin in human epidermal cells for the evaluation of amplification reaction of specimens and monitor the presence of PCR inhibitors, as well as to evaluate the nucleic acid extraction efficiency, in order to avoid a false negative result.