Evaluation of the LC-1000 Flow Cytometry Screening System for Cervical Cancer Screening in Routine Health Checkups

This study evaluated the performance of a flow cytometry system (LC-1000) in screening cervical precancerous lesions at routine health checkups.

In total, 928 health examinees were enrolled at 16 health promotion centers in 13 Korean cities between 2016 and 2017. All participants underwent liquid-based cervical cytology and flow cytometry testing to determine the cell proliferation index (CPIx).

The positivity rate of the LC-1000 system increased with the severity of the cervical cytology findings (p for trend < 0.001). When low-grade squamous intraepithelial lesion (LSIL) or higher (including LSIL, high-grade squamous intraepithelial lesion [HSIL], and atypical squamous cells without excluding HSIL [ASC-H]) was defined as gold-standard positivity, the sensitivity, specificity, PPV, and NPV of LC-1000 were 75.3% (95% confidence interval [CI], 66.8-83.7), 58.5% (95% CI, 55.2-61.9), 18.1% (95% CI, 14.5-21.8), and 95.1% [95% CI, 93.2-97.0], respectively. The median CPIx increased significantly from normal cytology to HSIL (p < 0.001). The median CPIx was higher in high-risk human papillomavirus (HR-HPV)-positive cases than in HR-HPV-negative cases (0.23 vs. 0.17, p < 0.001), while it did not differ between HR-HPV-positive and HR-HPV-negative cases with normal cytology findings (0.16 vs. 0.16, p = 0.700).

The LC-1000 system is potentially useful for screening cervical precancer and cancer, especially when excluding normal or ASC of undetermined significance cases in routinely screened populations.