The careGENE™ HPV screening kit-H is an automated qualitative in vitro test for the detection of human papillomavirus (HPV) DNA in patient specimens. The tests utilize amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high- risk HPV types in a single analysis. The tests simultaneously provide pooled results on high-risk genotypes and individual results on the highest-risk genotypes, HPV 16 and HPV 18, at clinically relevant infection levels. Cervical cell specimens can be collected in human cervical swab using liquid based preparation.

• Internal control: The ft-globin internal cellular control helps prevent false negatives. HPV negative specimens with a negative ft-globin result are flagged as invalid, helping prevent reporting of false negative results • Uracil-DNA Glycosylase (UDG) system application to prevent contamination • No cross reactivity: Demonstrates no cross-reactivity with non-high risk HPV genotypes, ensuring that positive results are clinically meaningful TaqMan probe qPCR technology utilizing polymerase chain reaction for amplification of specific target sequences and target specific probe for the detection...

The careGENE™ HPV screening kit-H was tested to detect HPV infection using 520 human cervical swab using liquid based preparation (403 positives and 117 negatives) by SNUH in Korea.

careGENE™ HPV screening kit-H for ABI 7500 System / Korea-IVD; CE-IVD Ordering Information -Unit: 100 tests/kit - Component: 2X Reaction Mixture, 4X Primer/Probe Mixture, Positive control, Nuclease free water, Instructions for Use e-mail: [email protected] WELLS BIO, INC. WWW.WellsbiO.net Tel: + 82 2-3660-6900 Seoul, 07795, Republic of Korea