Clinical Studies

Multi-center Study

Last October, Dr Wei lihui led a multi-center study in which the clinical performance of FRDTM was evaluated in the colposcopy clinics of 13 obgyn hospitals in Beijing, China. The study has been finished and currently, we are analyzing the data collected.








Cervical Cancer Screening Programme

Between October 2012 and June 2013 a cervical cancer screening programme in Xi’an, Shaanxi, China were performed. The aim of this study is to assess the clinical utility and feasibility of FRD for cervical cancer screening in gynecology clinics. A total of 9,949 married women, recruited in a gynecology clinic, were enrolled in this study. FRD was performed immediately after routine gynecological examination, and was followed by standard sample collection for liquid-based thin-layer cytology, and cytological analysis. Women with positive results in any of the screening arms were re-examined by colposcopy. Biopsy was performed if necessary, and the pathological diagnosis was considered the final diagnosis. Positive staining was found in 259 cases. For cases of cervical intraepithelial neoplasia (CIN) I, CIN II, CIN III, and cancer, the accordance rates of FRD with the pathological diagnosis were 88.9%, 60.0%, 76.9%, and 100%, respectively. With CIN II or higher-grade lesions considered abnormal cervical lesions, the sensitivity and specificity of staining for FRD were 75.0% and 81.6%, respectively.