Clinical Performance and Studies

TruScreen has been extensively tested in numerous studies around the world, with results showing its performance is equal to, or better than, high quality cytology tests within the same study.

TruScreen cervical screening

Across all studies, the performance of TruScreen was consistent and equal to, or better than in some studies, the comparing high quality cytology tests within the same study. In one multi-centre study, TruScreen was shown to detect precursors of cervical cancer (CIN 1-3) at an equivalent sensitivity to a top quality Pap smear. Ongoing studies confirm this performance.

Since TruScreen results come from an objective, self-checking digital system, they are free of the highly subjective human judgment required for cellular diagnosis on conventional Pap smears.

TruScreen can be effectively used with minimal training of medical or paramedical staff to allow cervical cancer detection without the infrastructure and resource costs associated with cytology based screening. TruScreen is also more acceptable to women than a conventional Pap test.

A comparative study between use of the TruScreen and the conventional Pap test at the Whittington hospital in London showed that TruScreen was associated with significantly less pain, pressure and scraping than experienced with the spatula or brushes used to collect cells from the cervix in cytology based screening.

Women also strongly preferred access to an immediate result.

The list of the papers published is as follow:

  1. Clinical evaluation of a real-time optoelectronic device in cervical cancer screening – Lihua Qiu et al 2021 click here to read
  2. TruScreen detection of cervical tissues for high-risk human papillomavirus–infected women during the coronavirus disease 2019 pandemic – Ziyao Wang et al. Click here to read
  3. A real-time optoelectronic device in screening of cervical intraepithelial neoplasia – Sung Jong Lee, MD & associates Department of Obstetrics and Gynecology, School of Medicine, Catholic University, Seoul, Korea – Published in the Journal of Women’s Medicine, Korean Society of Obstetrics and Gynecology March, 2009. Click here to read.
  4. Optoelectric Scanner TruScreen in Diagnostics of Cervical Squamous Intraepithelial Lesions – Sukhikh G.T. & Associates, Federal State Scientific Centre of obstetrics, gynaecology and perinatology after academician V.I. Kulakov, Moscow, Russia. Click here to read.
  5. The evaluation of a real-time optoelectronic method for the detection of Cervical Intrepithelial Neoplasia (“CIN’) – Pruski D. & Associates, Gynaecological Oncology Division, Department of Gynaecology, Obstetrics & Gynaecological Oncolgy, Poznan University of Medical Sciences, Poland 2008. Click here to read.
  6. The Australian Experience – Itzkowic, D & Cromer, D. Gynecologist, Bondi Junction, NSW Australia – Published the Australiasian Journal of General Practice 2005 (5) 2. Click here to read.
  7. TruScreen – a new ally for cervical cancer screening – Zannardi C, Camerini T, Bucolo C. -Published Ginecorama 2001; 26: 23-4. Click here to read.
  8. Optoelectronic method for detection of cervical intraepithelial neoplasia and cervical cancer – D. Pruski and associates. Karol Marcinkowski University of Medical Sciences, Poland – Published Opto-Electron.Rev.,19, no. 4, 2011. Click here to read.
  9. An optoelectronic cervical cancer screening system for screening cervical cancer: comparison with cervical cytology – HE Xiu-kui and associates, Guangdong Provincial Women and Children’s Hospital, Guangzhou China – Published (J South Med Univ, China) 2010; 30(10). Click here to read.
  10. Comparing Study of cervical cancer screening System and liquid-based cytology test in the screening of cervical lesions – Lu Siji and associates, East Hospital, Tongji University, Shanghai- Published Obstet Gynecol, Feb, 2009, Vol.18, No.2 (China). Click here to read.