Effectiveness of TruScreen for Detecting CIN2+ in Women with ThinPrep Cytologic Test Results Indicating Atypical Squamous Cells of Undetermined Significance and Low-Grade Squamous Intraepithelial Lesions

Abstract

Objective: To evaluate the effectiveness of TruScreen (TS) for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in women with abnormal ThinPrep cytologic test (TCT) results. Methods: 466 women with atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesion (LSIL) were enrolled and underwent TS, colposcopy and biopsy examination. Results: Compared with the high-risk human papillomavirus (hrHPV) test for CIN2+, significantly higher specificity of TS, combined TS and hrHPV (69.6 and 75.0 vs 36.8% in ASCUS; 59.0 and 69.9 vs 30.1% in LSIL), significantly higher positive predictive value of combined TS and hrHPV were observed (32.7 vs 24.6% in ASCUS; 47.9 vs 35.6% in LSIL). Conclusion: TS combined with hrHPV showed better performance in diagnosing CIN2+ in ASCUS/LSIL.

Keywords: :

• ASCUS
• cervical cancer screening
• cervical transformation zone
• CIN
• LSIL
• TruScreen

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2217/fon-2023-0297

Author contributions

All authors contributed to the conception and design of the study. X Yang carried out the research, analyzed the data, interpreted the data and drafted the article. L He operated colposcopy examination and biopsy. X Xiao, L Yan, L Shi, Z Ren and H Cai coordinated the cervical screening activities. C Fu interpreted the data and drafted the article. All authors reviewed the article and critically revised it for important intellectual content. All authors reviewed and approved the final article for publication.

Acknowledgments

The authors wish to thank Yu-Ligh Liou for assistance in the study design and helpful discussion.

Financial disclosure

This work was supported by the National Natural Science Foundation Project of China (81771546), the Clinical Medical Technology Innovation Guidance Project of Hunan Provincial Science & Technology Department (2018SK52508 and 2020SK53404) and the Research Project of Hunan Provincial Health Commission (2021050120344). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, stock ownership or options and expert testimony.

Writing disclosure

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.