AffiPCR® HPV 16/18 Quantitative Real Time PCR

Target Disease Type: HPV Associated Kits

Specific Application: High cancerogenic Risk HPV Typing

Storage and Shipping : 4 weeks

HPV 16/18 RT-PCR Quant (CE) V12-100FRT DataSheet

INTRODUCTION

Genital infection with HPV is one of the most common sexually transmitted diseases (STDs) of viral etiology worldwide (20% - 46% in different countries in sexually active young women) . Cervical cancer is the second most common cancer in women worldwide, and a compelling body of clinical, epidemiological, molecular, and experimental evidence has established the etiological relationship between some sexually transmitted HPV genotypes and cervical neoplasia throughout the world. Based on the frequency of detection of HPV genotypes from different grades of Cervical Intraepithelial Neoplasia (CIN Grades I – III), HPV genotypes are subdivided into High-risk HPV types Intermediate-risk types and Low-risk types.

Several methods have been used to diagnose clinical or subclinical infection with HPVs including clinical observation, cytological screening by Pap smear, electron microscopy, immunocytochemistry, but these methods have some disadvantages such as non-standardization and subjectivity, insufficient sensitivity and low predictable value. The most perspective way of HPV diagnosis is a direct detection of DNA of the human papilloma virus of high carcinogenic risk by the polymerase chain reaction. While the value of the Pap smear in routine screening for cervical displasia is undisputed, it is now known that 99% of cases of cervical carcinoma are caused by infection with twelve genotypes of the human papilloma virus (HPV) . Identification of these high-risk genotypes is very valuable in the management of cervical carcinoma, both as a prognostic indicator and as a secondary screening test where results of a Pap smear are inconclusive. Results from the combination of the Pap smear and the HPV DNA test can aid in determining the intervals for screening.

The PCR-based methods have been used successfully for the detection and typing of genital HPV genotypes in clinical specimens such as cervical swabs or scrapes, cervicovaginal lavages, frozen biopsies and formalin-fixed paraffin-embedded tissues.

INTENDED USE

kit HPV 16/18 Real-TM Quant is an in vitro Real Time amplification test for quantitative detection and genotyping of Human Papillomavirus (16, 18) in the urogenital swabs and biopsies.

PRINCIPLE OF ASSAY

kit HPV 16/18 Real-TM Quant is based on two major processes: isolation of DNA from specimens and multiplex Real Time amplification. Amplification results of HPV 16 DNA are detected on the Fam/Green channel, amplification results of HPV 18 DNA are detected on the Rox/Orange channel and β-globine gene used as Internal Control is detected on the Joe/HEX/Yellow channel. If the swab is not correctly prepared (high quality of mucous or insufficient quantity of epitelial cells (< 103-105) the Internal Control will not be detected or come very low.