AmoyDx® High-risk Human Papillomavirus (HPV) Detection Kit | 8.01.25802X048E

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AmoyDx® High-risk Human Papillomavirus (HPV) Detection Kit | 8.01.25802X048E | AmoyDx

Human papillomavirus (HPV) is a sexually transmitted DNA virus that establishes infection in squamous epithelial cells in the human body. There are more than 200 types of HPV, which can be classified into high or low-risk types depending upon their oncogenic potentials. High-risk HP Vs also called oncogenic HP Vs, which have been confirmed to cause cancer, includes HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 5658, 59, and 68. And some HP Vs are possibly carcinogenic to humans, like HPV26, 53, 66, 70, 73 and 82, that be classified as high-risk or probably high-risk HP Vs. Low-risk HP Vs can cause genital warts and low-grade changes in the cells, but rarely cause cancer, such as HPV6 and 11. High-risk HPV infection is a necessary for the development of cancers of the uterine cervix, which has been firmly established. Approximately 99.7% of cervical cancers are caused by high-risk HPV infection. Cervical cancer is the second-most frequent malignancy among women worldwide.

Intended Use

The AmoyDx® Human Papillomavirus (HPV) Genotyping Detection Kit a real-time PCR assay for qualitative detection of 19 high-risk HPV DNA (HPV 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 70, 73, and 82) and two low-risk HPV DNA (HPV 6 and 11) in cervical exfoliated cells and urogenital tract secretion. The kit is intended to access the high risk HPV DNA and aid in cervical cancer screening, early diagnostics and treatment.

The kit is for research use only, and intended to be used by trained professionals in a laboratory environment.

Testing Procedure
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Additional Information

48 Tests/Kit
CE marked
PCR Instrument (stated in IFU):
Stratagene Mx3000P™, ABI 7500, LightCycler480, Bio-Rad CFX96, SLAN-96S, Rotor-Gene Q/6000 (72 wells)
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