Human Papillomavirus Real Time PCR Kit

Beskrivning

Introduction

Cervical cancer is a life-threating disease in the women’s cervix, which is the fourth killer among cancers for females.

The human papillomavirus (HPV) is a group of DNA virus that only infect with human mucosal cells or epithelial cells and can cause to cancer. There are more than 100 types of HPV. Each type has specific preferred infected area. These HPV can be classified into two groups according to the potential risks to develop cancer, high-risk HPV (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59, 66 and 68) and low-risk HPV (6, 11, 81).

The infection of high-risk HPV has a strong association with incidence of cervical cancer. High-risk HPV DNA can be found in 99% cervical cases, that 70% of which were caused by high-risk genotype HPV-16 and HPV-18. High-risk HPV DNA screening can more sensitively identify cervical intraepithelial neoplasia (CIN) than other methods. It enables women to access diagnosis at the early stage of HPV infection and to get treatment before development of precancerous lesions and cervical cancer.

Cervical cancer is a preventable cancer. To decrease morbidity and mortality of cervical cancer, encouraging women to take regular HPV screening is important. By the guideline published by WHO in 2021, WHO recommends using HPV DNA detection as the primary screening test for both of” screen-and-treat approach” and “screen, triage and treat approach”.

Bioperfectus Human Papillomavirus Real Time PCR Kit is a qualitative PCR assay intended to detect 18 high-risk genotypes of the human papillomavirus (HPV), including HPV-16, HPV-18 and other 16 common oncogenic types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, 73, 53, 82 and 26). It has high specificity and sensitivity, can be used for primary cervical cancer screening. Specific genotypes identified can assist doctors to further decide triage and treatment and  reduce morbidity and prevalence of cervical cancer.

Features

• Easy screening: 100 mins to complete 96 tests
• Cost-saving: compatible for most mainstream real-time PCR instruments, no specific system required
• Fulfillment of clinical use: respectively report HPV-16 and HPV-18 as primary evidence for cervical cancer screening
• Reliable performance: high sensitivity and specificity validated in clinical sites
• Cytologic sample detectable (ThinPrep®, BD SurePath^TM)

Parameters

*No specific rules as for non-cytologic samples (cervical swabs).

Certificates

CE, NMPA