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

@entity1 @entity5 @entity957 @entity1082 @entity420 @entity3146
PURPOSE: This study assessed the performance of a novel flow cytometry (FCM) cervical @entity5 screening system compared with @entity1082 ) Hybrid Capture 2 (HC2). METHODS: Chinese @entity1 aged 20years or older were enrolled in this study at Fudan University Shanghai @entity5 Center. All @entity1 underwent cytology/pathology testing (gold standard), HPV HC2 testing and FCM testing involving analysis of cell proliferation index (CPIx). RESULTS: Among 437 @entity1 enrolled in this study, 185 @entity1 (42.3%) were diagnosed as "gold standard positive" by pathology with diseases including @entity3146 ( @entity3146 ) grade 2 (n=11), CIN3 (n=41), @entity957 ( @entity957 ; n=115), @entity420 in situ (n=2) and @entity420 (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 20-29years 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 @entity957 specimens. CONCLUSIONS: Our results showed that the FCM screening system had high sensitivity and specificity for @entity1 of various ages. The FCM CPIx was able to evaluate the severity of disease quantitatively.
