The High Risk HPV Genotyping Kit is a qualitative in vitro test used for HPV genotyping and cervical cancer screening using cervical cells collected by swab, TCT or LCT. This test utilizes Polymerase Chain Reaction (PCR) for DNA amplification and nucleic acid hybridization for the detection of high-risk HPV types in one reaction. This test specifically identifies 14 high-risk HPV types, including HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-56, HPV-58, HPV-59, HPV-66, and HPV-68.
The test is indicated 1) to screen patients age 21 and older with ASU-US (atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy, and assess the presence of high-risk HPV, to guide patient management together with the physician’s assessment of cytology history, other risk factors, and professional guidelines; 2) to use with cervical cytology to adjunctively screen to assess the presence of high risk HPV types in women age 30 and older, considering other risk factors such as cytology history to guide patient management.
The Sanity 2.0 H-HPV is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

Principle

The Sanity 2.0 H-HPV is based on the technology of multi-color melting curve analysis (MMCA). HPV genotypes are identified by the different Tm values of hybridizing PCR products with the fluorescent probes. Several HPV type-specific probes are designed with the same fluorophore and quencher that will be detected in one single channel. It was designed that the Tm value of each probe-target hybrid differs with varied length and G/C content of the probe. According to this design, 14 high-risk HPV genotypes can be accurately distinguished in a single reaction. At the same time, human glyceraldehyde-3-phosphate dehydrogenase (GAPDH) gene can be dectected for quality control of sample collection, extraction and amplification as an internal control (IC). For ease of storage and transportation, the amplification reagent is designed in pre-distributed dry form.

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