This diagnostic kit is an in vitro nucleic acid amplification test for the detection of high-risk papillomavirus (HPV)(Type 16 and18) DNA in reproductive tract secretions. It is intended for use as an aid in diagnosing an HPV (Type 16 and18) infection, and the early screening of cervical cancer.
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 a pair of specific primers which are designed to target at a conserved sequence of HPV-DNA( Type 16 and 18), a specific fluorescence probe, accompanied with PCR mix,to achieve fast detection of HPV-DNA(Type 16 and 18) 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 an internal control to monitor the presence of PCR inhibitors in test specimens by detecting whether the internal control signal is normal in order to avoid a false negative result.