High-Risk HPV Multiplex Real-time PCR Kit, IVD

Papillomaviruses constitute a diverse group of DNA viruses with the ability to infect both the skin and mucous membranes of humans and animals. The Human Papillomavirus (HPV) is particularly significant, being implicated in over 99% of cervical cancers worldwide. More than 200 distinct types of HPV have been catalogued and classified as high-risk (HR HPV) or low-risk (LR) for cervical cancer development. High-risk HPVs include types 16 and 18, responsible for a substantial ~75% of the most severe, cancerous lesions. Additional types of high-risk, such as HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59, HPV66, and HPV68, collectively contribute to over 90% of cervical adenocarcinomas.

Nowadays, HR HPV screening or diagnosis mostly involves cytological techniques that have less specificity and sensitivity than molecular techniques. Cervicovaginal cytology or liquid-based cytology are proficient in detecting precursor lesions and indicating cervical cancer presence following HPV infection. However, these methods, while effective in identifying precursor lesions and indicating the presence of cervical cancer after HPV infection, have limitations in distinguishing between different virus types, specifically various high-risk HPV types. Application of fast real-time PCR-based assays for HPV screening from cervical samples can decrease turnaround time and increase the sensitivity and specificity of diagnostic

NZYtech’s High-Risk HPV Multiplex Real-time PCR Kit, IVD utilizes real-time amplification of target DNAs by polymerase chain reaction and nucleic acid hybridization for detection of HPV HR types 16, 18, and a pool of HPV31, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. This kit detects amplification using fluorogenic target-specific hybridization probes for detection of: HPV16 through TexasRed/JUN channel, HPV18 through Cy5 channel, and a pool of other HR HPV through FAM channel. Also, an endogenous control was included in our kit that is detected in a fourth channel – HEX/VIC/JOE.