The Qiagen digene HPV Genotyping PS Test is an in vitro diagnostic assay designed for the qualitative detection of high-risk human papillomavirus (HPV) types 16, 18, and 45. It is intended for use with the digene HC2 High-Risk HPV DNA Test to provide specific genotyping information, aiding in the identification of women at increased risk for cervical cancer. By targeting these three high-risk HPV types, the test supports clinicians in making informed decisions regarding patient management and follow-up care.

Key Technical Features:

Targeted Detection: Identifies HPV genotypes 16, 18, and 45, which are associated with a higher risk of cervical cancer.

Complementary Use: Designed to be used in conjunction with the digene HC2 High-Risk HPV DNA Test for enhanced diagnostic specificity.

Clinical Application: Assists in stratifying patients based on their risk, facilitating personalized follow-up and treatment strategies.

Regulatory Compliance: Developed in accordance with regulatory standards for in vitro diagnostic medical devices.

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