Shuo Shi Biology: Human Papillomavirus Nucleic Acid Test Kit Expected Use Change.

Shuo Shi Biology announced that they have recently received approval from the National Medical Products Administration for the change in registration of their medical device. The expected use of the Human Papillomavirus Nucleic Acid Test Kit product has been modified. The original intended use was for the qualitative detection of 18 HPV genotypes in cervical epithelial cells of women, with genotyping for HPV16 and HPV18, while the other 16 HPV genotypes are not specifically genotyped, and the product should not be used for screening for cervical cancer. The revised intended use is for the qualitative detection of 18 HPV genotypes in cervical epithelial cells of women, with genotyping for HPV16 and HPV18, while the other 16 HPV genotypes are not specifically genotyped. It can be used for screening for cervical cancer in women aged 30 and older by detecting high-risk HPV infections, in combination with cervical cytology examination, or as a standalone screening test. This test, combined with the patient's cytology history and other risk factors assessment, as well as clinical diagnosis and screening guidelines, is intended to guide patient management.