Abstract
The study focuses on a novel automated system used for cervical cancer testing, which utilizes flow cytometry (FCM). The feasibility of applying the system for cervical cancer testing was examined. The study was approved by the Ethics Committees of the Japanese Red Cross Society Musashino Hospital, and Sysmex Corporation.746 of Liquid based cytology specimens were collected from patients who were treated at our department between September 2011 and February 2013. Informed consent was obtained from the patients to participate in this study.
The system automatically performed the pre-treatment, DNA staining and FCM measurements. It also analyzed the measurement data of the equivalent amount of DNA in epithelial cell populations. Finally, the cell proliferation index based on the analysis was outputted. The median of CPIx for each specimen was compared with Histology results: 0.186 for < CIN1 (n = 32), 0.238 for CIN1 (n = 47), 0.351 for CIN2 (n = 18), 0.534 for CIN3, (n = 24), and 0.759 for squamous cell carcinoma (n = 15). The positive rate in patients exhibiting CIN2 or higher (CIN2+) in the study (n = 61) was observed as being favorable at 95.1% (95% confidence interval [CI], 86.5-98.3%). The negative rate observed in patients negative for intraepithelial lesion or malignancy) as well as < CIN1 patients was 76.3 % (95% CI, 72.8-79.6% [455/596]).
The system showed a favorable performance to detect CIN2+. This shows that it might be utilized to provide a support information for the diagnosis of cervical cancer.
