A novel highly sensitive and specific flow cytometry system for cervical cancer screening

•A new automated FCM cervical screening system showed a high sensitivity and specificity.•The CPIx increased statistically with the lesion degrees.•This FCM testing has the potential to be a cervical cancer and precancerous screening method.

PurposeThis study assessed the performance of a novel flow cytometry (FCM) cervical cancer screening system compared with human papillomavirus (HPV) Hybrid Capture 2 (HC2).MethodsChinese women aged 20 years or older were enrolled in this study at Fudan University Shanghai Cancer Center. All participants underwent cytology/pathology testing (gold standard), HPV HC2 testing and FCM testing involving analysis of cell proliferation index (CPIx).ResultsAmong 437 women enrolled in this study, 185 women (42.3%) were diagnosed as “gold standard positive” by pathology with diseases including cervical intraepithelial neoplasia (CIN) grade 2 (n = 11), CIN3 (n = 41), squamous cell carcinoma (SCC; n = 115), adenocarcinoma in situ (n = 2) and adenocarcinoma (n = 16). The remaining 252 cases were deemed “gold standard negative”. The sensitivity was 87.6% (95% CI, 82.8–92.3) for FCM testing and 89.7% (95% CI, 85.4–94.1; p = 0.5121) for HPV HC2 testing. The specificity of FCM testing was 90.5% (95% CI, 86.2–94.7), which was superior to the specificity of HPV HC2 testing (84.5%, 95% CI, 79.3–89.7; p = 0.04). In the 20–29 years old group, the sensitivity and the specificity of FCM testing were 90.0% (95% CI, 71.4–100.0) and 92.9% (95% CI, 76.9–100.0), respectively. The FCM testing CPIx statistically increased with the transition from normal cervical specimens to SCC specimens.ConclusionsOur results showed that the FCM screening system had high sensitivity and specificity for women of various ages. The FCM CPIx was able to evaluate the severity of disease quantitatively.