Beskrivning
Clinical background: Human papillomavirus (HPV) is a 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.
The study shows that the persistent infection of HPV is the main cause of cervical carcinoma and precancerous lesion[1].Studies show the persistent infection of human papillomavirus is the main cause of cervical carcinoma and precancerous lesion. 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].
Base on the study results by WHO International Agency for Research on Cancer (IARC) and other international organizations, the 13 kinds of genotypes including HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68 are classified as high-risk HPV, and the 5 kinds of genotypes including HPV26, 53, 66, 73, 82 are classified as medium-risk HPV. This diagnostic kit chooses the above 13 kinds of high-risk genotypes and two popular kinds of medium-risk genotypes that are HPV53 and 66 to be the target genotypes, in order to guarantee that the kit is capable of cervical carcinoma screening and risk evaluation. Moreover, it is clearly indicated that the females at the age of 30 or above who have no abnormal cervical cytology but the HPV detection is positive, especially for HPV16 and HPV18 infected females, should get vaginoscopy immediately[4,5]. Therefore, the kit can be used for detection of the 15 kinds of target genotypes and also subtype identification of HPV16 and HPV18.
So far, it is difficult to test HPV by the use of conventional virus culture or serological technology. The main detection technology used in laboratory is molecular biological methods based on nucleic acid test. There are two main methods in this technology, one method based on target sequence amplification: type-specific PCR, mRNA amplification test, primer PCR, real-time (multiplex) PCR fluorescence technology, etc.[6,7], and the other method based on signal amplification technique: Amplification technique of liquid phase, morphology, enzyme digestion, etc.
