A real-world multicenter study on opportunistic cervical cancer screening in hospital in China: comparison of TruScreen device, cytology, and HPV testing for detecting high-grade cervical lesions.

INTRODUCTION

Cervical cancer (CC) remains a major health challenge worldwide. Early detection methods and screening strategies are important for reducing both incidence and mortality rates.

OBJECTIVES

This study evaluates the clinical performance of the real-time optoelectronic device, TruScreen (TS), in detecting high-grade cervical precancers compared to standard methods [high-risk human papillomavirus (hrHPV) testing, cytology, and colposcopy) in a Chinese hospital-based opportunistic screening cohort. In addition, assess the clinical effectiveness of the TS strategies alongside current guidelines and methodologies in cervical cancer screening.

METHODS

A multicenter, cross-sectional study was conducted across 64 hospitals between September 2018 and June 2021 in China. Participants (n = 14,982 women aged ≥ 20 years) underwent TS test, hrHPV test, liquid-based cytology (LBC), and colposcopy with biopsy confirmation. Diagnostic performance [sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV)] were calculated using histopathology as the gold standard. Strategies incorporating TS test were compared to WHO-recommended guidelines.

RESULTS

For cervical intraepithelial neoplasia grade 2 and servier lesions (CIN2+), TS test demonstrated comparable sensitivity (87.0%; 95% CI: 84.8–88.9%) to hrHPV (91.9%) and higher specificity (57.2% vs. 29.2%) than cytology (53.6%). TS test demonstrated outperformed compared to cytology in CIN3+ (sensitivity: 90.0% vs. 62.7%) and maintained high NPV (97.9%). In women aged ≥ 45 years, TS test showed comparable sensitivity (88.5%) to hrHPV test (87.9%) and higher specificity (60.1%) than hrHPV (27.5%) and cytology (46.9%) in CIN3+. Strategy 3, TS combined hrHPV testing, achieved the lowest missed cancer cases (n = 14) and balanced referral rates (19.65%), produced the best results among the methods compared.

CONCLUSION

The straightforward operation and non-invasive detection of TS test demonstrate high sensitivity and NPV, establishing it as a viable tool for opportunistic early CC screening in hospitals, particularly among older women. The combination of TS test with hrHPV test enhances both sensitivity and specificity, thereby minimizing unnecessary colposcopies. Further large-scale studies are required to validate its long-term effectiveness in low- and middle-income countries (LMICs).