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Observational Study
. 2025 Apr 21;25(1):198.
doi: 10.1186/s12905-025-03733-z.

Cervical cancer screening: a comparative study of TruScreen vs. Pap Smear

Majed Alhudhud  1 , Shazia Maqsood  2 , Maab El Hussein  2 , Rifat Shaheen  2 , Hiba Sarhan  3 , Sadia Aslam  3 , Hisham Al Khalidi  4 , Amina Butt  5 , Mazen Bishtawi  6
Affiliations
Observational Study

Cervical cancer screening: a comparative study of TruScreen vs. Pap Smear

Majed Alhudhud et al. BMC Womens Health. .

Abstract

Objectives: This study aimed to evaluate the potential of real-time optoelectronic device (TruScreen™; TS; TruScreen Group Limited, New Zealand) as an alternative or adjunct to Pap Smear (Liquid Based Cytology (LBC)) for cervical cancer screening.

Method: We conducted a prospective observational pilot study involving 507 women who were routinely followed at gynecology clinics. All participants underwent TS and LBC examinations after study enrolment. Those with abnormal findings were referred for colposcopy and cervical biopsy within one month.

Results: Overall, 507 women fulfilled the eligibility criteria and were included in this study, of which 30 women (5.9%) had abnormal TS findings and underwent colposcopy. Thirteen women (43.3%) had low-grade lesions, and only one (3.3%) had a high-grade lesion. Regarding biopsy findings, three women had cervical intraepithelial neoplasia (CIN) 1, two women had 'CIN2 + , and one had glandular hyperplasia. The TS yielded a sensitivity of 83.3% (95% CI: 35.9-99.6%) and a specificity of 95% (95% CI: 92.7- 96.8%) for the detection of cervical abnormality, compared to 66.7% (95% CI: 22.3-95.7%) and 98.2% (95%: CI 96.6%-99.2%) of the Pap smear, respectively. The difference between both screening tools was not statistically significant (p = 0.91). The sensitivity (100%, 95% CI 15.6-100%) and specificity (95.6%, 95% CI 93.4-97.2%) of TS and Pap smear for 'CIN2 + lesions were notably high.

Conclusion: TS demonstrated potential as a screening tool for cervical neoplasms in this preliminary study. The tool did not require cervical samples, laboratory equipment, or highly trained personnel. While our findings suggest the potential for real-time and accurate screening, further research with a larger sample size is necessary to confirm its reliability and practicality.

Keywords: CIN; Cervical cancer; Optoelectronic cervical screening; Optoelectronic device; Pap smear; Real-time screening; TruScreen.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Ethics Committee of the institutional review board (IRB) (Ref No. Dr. Sulaiman Al-Habib Medical Group – RC20.08.91- Aug 2020). All patients were required to sign the informed consent before enrolment. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
TruScreen ultra handheld device
Fig. 2
Fig. 2
Images of the Probing Pattern as Shown in the TruScreen Instruction Manual. Begin probing the outer area of the ectocervix at Spot 1 on the left-hand side and move horizontally from left to right. Complete two rows, to ensure covering the entire anterior part of the ectocervix
Fig. 3
Fig. 3
The Posterior Part of the Ectocervix. It should proceed horizontally from left to right as depicted above
Fig. 4
Fig. 4
Distribution of TruScreen Findingd According to Pap Smear Results. Abbreviations; ASCUS: atypical squamous cells of undetermined significance, HSIL: high-grade squamous intraepithelial lesions, LSIL: low-grade squamous intraepithelial lesions
Fig. 5
Fig. 5
Distribution of Colposcopy Findings. *Unsatisfactory colposcopy results indicate that the squamocolumnar junction cannot be visualized. Abbreviations; SCJ: squamocolumnar junction
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