关键词: 宫颈癌, 筛查, 体外诊断试剂, 临床试验

Abstract:

 In clinical practice， the regular screening of cervical cancer for women of eligible age is the main measure of secondary prevention of cervical cancer. Currently， the method of cervical cancer screening include ThinPrep cytologic test， human papillomavirus （HPV） detection， methylation test for cervical cancer-related genes， colposcope， histopathology， etc. Except for colposcopy， all the above-mentioned examinations need in vitro diagnostic reagents or analytical software. This study systematically elaborates on the application of in vitro diagnostic reagent products and analytical software in the process of cervical cancer screening in China， deeply analyzes the clinical application of marketed products and the progress of clinical trials. and studies the clinical trial design requirements for cervical cancer screening-related products in combination with the considerations in the technical review process of relevant products， elaborating on the scientific and rational nature of these requirements， and provide suggestions for the clinical trial design of this type of product and its expected clinical application scenarios， so as to provide reference for relevant medical device manufactures and principal investigators of clinical trials to enable more scientific and rational design of clinical trials for relevant products， to fully evaluate the safety and effectiveness of the products， and to promote the products to be marketed as soon as possible.

Key words: Cervical cancer, Screening, In vitro diagnostic reagents, Clinical trials