A rapid test for the qualitative detection of Human Papillomavirus antigen in human cervical swab specimen. For professional in vitro diagnostic use only.

INTENDED USE
The HPV Antigen Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of Human Papillomavirus antigen in human cervical swab specimen as an aid for the screening of cervical cancer and infection of HPV-16/18.

SUMMARY
HPVs are distinguished and typed by DNA sequence homology. At least 100 types have been identified. High-risk HPV types can initiate the development of cervical carcinoma and oropharyngeal, esophageal, penile, and anal cancers. Viral DNA is found in benign and malignant tumors, especially mucosal papillomas. Almost all cervical carcinomas contain integrated HPV DNA, with 70% from HPV-16 or HPV-18. The E5, E6, and E7 proteins of HPV-16 and HPV-18 have been identified as oncogenes.¹

Human papillomavirus (HPV) is the most common viral infection of the reproductive tract and can cause cervical cancer in women, other types of cancer, and genital warts in both men and women. Including 5 new introductions, 116 Member States have introduced HPV vaccine by the end of 2021. Since many large countries have not yet introduced the vaccine and vaccine coverage decreased in 2021 in many countries, global coverage with the first dose of HPV among girls is now estimated at 15%. This is a proportionally large reduction from 20% in 2019.²