This diagnostic kit is an in vitro nucleic acid amplification test for the detection of low-risk papillomavirus (HPV)(type 6/11) DNA in reproductive tract secretions. It is intended for use as an aid in diagnosing an HPV (type 6/11) infection and patients with clinically suspected genital warts.
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(genotype 6/11), a specific fluorescence probe, accompanied with PCR mix, to achieve fast detection of HPV-DNA(genotype 6/11) through fluorescent signal changes.
The whole test process eliminates the need to extract DNA from specimens. Add the specimen eluent into PCR reaction tube and mix it thoroughly with nucleic acid lysis buffer, which then can be used as a template for PCR amplification. Hence, it avoids environmental contamination resulting from regular nucleic acid extraction process.
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.