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 PCR technology and Taqman technology, this test utilizes pairs of specific primers and specific fluorescence probes of the above-mentioned 15 HPV-DNA types, for the genotyping of the15 HPV DNA via 8 reaction tubes.
It just requires to mix specimen eluent with lysis buffer and use it as template for PCR amplification, eliminating the need to extract DNA from specimens thus avoiding contamination caused to the environment as routine nucleic acid extraction does.
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.