15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Primary DI

16955792730622

Basic UDI-DI Code

B-16955792730622

Reference

S3360E-48

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Sansure Biotech Inc.

Clinical background: Human papillomavirus (HPV) is a kind of non-enveloped double-stranded circular DNA virus of small molecular weight. It infects and parasitizes epithelial cells of human reproductive organs and other organs. HPV falls into two types clinically, high-risk and low-risk HPV, according to the different degrees of pathogenicity or carcinogenic risk of different subtypes. Low-risk HPV mainly causes pathological changes such as exogeneity wart in anal skin, male external genitalia, female labia, urethral orifice and vagina lower segment, and low-grade cervical intraepithelial neoplasia. High-risk HPV can cause not only external genital warts, but more seriously, external genital cancer, cervical carcinoma and high-grade cervical intraepithelial neoplasia. Studies show persistent infection of human papillomavirus is the main cause of cervical carcinoma and precancerous lesion.1 High-risk HPV DNA can be detected in 99.7% patients with cervical carcinoma. Because of the close relationship between high-risk HPV and cervical carcinoma, it is a significant screening method to test HPV for cervical carcinoma.2,3 Curative effect is much better when applying treatment in early cervical lesions than in cervical cancer. Screening can facilitate early diagnosis and treatment and thus have lower incidence and mortality of invasive carcinoma of cervix.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).