The HPV28 Genotyping Kit (Sanity 2.0) 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 HPV types in a fully automatic instrument Sanity 2.0 System (all-in-one machine). This test specifically identifies 28 HPV types of 14 high-risk HPV types and 14 low-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, HPV-68,
HPV-11, HPV-6, HPV-53, HPV-26, HPV-42, HPV-69, HPV-81, HPV-43, HPV-40, HPV-72, HPV-44, HPV-61, HPV-54, HPV-70

 
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 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 HPV types in women age 30 and older, considering other risk factors such as cytology history to guide patient management.

 
The HPV28 Genotyping Kit 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.

CE-IVD Marked