INTENDED USE
In vitro diagnostic medical device for screening of human papillomavirus (HPV).
The careGENETM HPV detection kit-M is designed to detect 25 types of human papillomavirus types (HPV). In conjunction with qPCR, it can genotype 4 high-risk HPVs (16, 18, 31, and 59) and 3 low-risk HPVs (6, 53, and 61). It can collectively detect 10 other high-risk HPVs (HPV 33, 35, 39, 45, 51, 52, 56, 58, 66, and 68), and 8 other low-risk HPVs (HPV 11, 40, 43, 44, 54, 70, 73, and 81) from crude cervical scraping (Liquid based Cytology).
KEY FEATURES AND BENEFITS
√ Limit of Detection ≥ 10 copies/rxn
√ Verification of sample extraction and amplification efficiency using endogenous internal control
√ High analytical sensitivity
√ Uracil-DNA Glycosylase (UDG) system applied
√ Compatibility – Flexible open system