AffiPCR® HPV 6/11 Real Time PCR

Target Disease Type: HPV Associated Kits

Specific Application: Low cancerogenic Risk HPV Typing

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HPV 6/11 RT-PCR (CE) V11-100FRT 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. Genital warts (technically known as condylomata acuminata) are most commonly associated with two HPV types, HPV 6 and HPV 11.

Several methods have been used to diagnose clinical or subclinical infections 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 values. 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.

Recently many countries introduced quadrivalent HPV 6/11/16/18 Vaccine program therefore the detection of HPV 6 and 11 types can be used for the evaluation of efficiency of the profilaxis.

INTENDED USE

The kit HPV 6/11 Real-TM is an in vitro Real Time amplification test for qualitative detection of Human Papillomavirus 6 and 11 in the urogenital swabs.

PRINCIPLE OF ASSAY

The kit HPV 6/11 Real-TM is based on two major processes: isolation of DNA from specimens and Real Time amplification. PCR-mix-1 tube contains primers directed against regions of HPV types 6, 11 and β-globine gene used as Internal Control. If the swab is not correctly prepared (high quantity of mucous or insufficient quantity of epithelial cells) the Internal Control will not be detected or will be low (the quantity of epithelial cells lower than 103 cells/reaction) . HPV 6 is detected on the FAM (Green) channel, HPV 11on the JOE (Yellow) /Cy3/HEX channel and Human β-globine gene on the ROX (Orange) /Texas Red channel.