The careGENE™ 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). This kit was developed based onTaqMan probe qPCR technology, utilizing polymerase chain reaction (PCR) for the amplification of specific target sequences and target specific probes for the detection of amplified HPV DNA.

• Uracil-DNA Glycosylase (UDG) system application to prevent contamination • No cross reactivity: Cross-reactivity was tested by using 1 xl 05~1 xl 06 CFU/mL of low or high TaqMan probe qPCR technology utilizing polymerase chain reaction for amplification of specific target sequences and target specific probe for the detection of the amplified DNA. B-globin Human Genome High Risk Type non-infection [Fluorescent Reporter]

The careGENE™ HPV detection kit-M was tested to detect HPV infection using 598 human cervical swabs using liquid based preparation in Korea. Clinical Sensitivity

careGENE™ HPV detection kit-M is approved by the Ministry of Food and Drug Safety in South Korea and obtain a CE mark for in vitro diagnostic medical device. - Component: 2X Reaction Mixture, Mix H, Mix L, PC1,PC2 Nuclease free water Instructions for Use e-mail: [email protected] 16, Magokjungang8-ro 1-gjl, Gangseo-gu. Seoul 07795, Republic of Korea