TITLE:
Revolutionising Cervical Cancer Screening: Role of Truenat HPV DNA Point-of-Care Testing
AUTHORS:
Aliou Diouf, Djibril B. Sow, Cheikh C. T. Sarr, Magatte Mbaye
KEYWORDS:
Cervical Cancer Screening, HPV, Truenat Testing
JOURNAL NAME:
Open Journal of Obstetrics and Gynecology,
Vol.16 No.10,
October
27,
2026
ABSTRACT: Background: Cervical cancer remains a major public health concern, particularly in resource-limited settings where delayed screening, reporting, and treatment contribute to preventable morbidity and mortality. High-risk human papillomavirus (HPV) DNA testing has emerged as an effective primary screening strategy, and point-of-care platforms may reduce loss to follow-up by enabling rapid clinical decision-making. Objective: This study aimed to evaluate the clinical performance, feasibility, turnaround time, and clinical utility of the Truenat HPV-HR assay, which detects HPV genotypes 16, 18, 31, and 45 only, for cervical cancer screening in a gynaecology outpatient setting. Methodology: A one-year hospital-based observational study was conducted in the Department of Obstetrics and Gynaecology at Regional Hospital Center of Saint-Louis, from 01/04/2024 to 31/03/2025. A total of 250 non-pregnant women were enrolled. The protocol targeted women aged 30 - 65 years; however, 27 enrolled participants were older than 65 years. Participants underwent Truenat HPV DNA testing using a portable point-of-care molecular platform detecting HPV genotypes 16, 18, 31, and 45. Colposcopy was performed in 40 participants and histopathology was available for 15 participants; clinical performance was estimated only within these selected subsets. A positive colposcopy was defined as finding abnormal cells on the cervix, vagina or vulva that require further investigation, typically via biopsy and a positive histopathology as cervical intraepithelial neoplasia grade 1 or worse (CIN1+); CIN grade 2 or worse (CIN2+) was analysed as an additional target condition. Results: Of the 250 participants, 31 (12.4%; 95% CI: 8.6% - 17.1%) tested positive for HPV 16/18/31/45. Among the 40 women who underwent colposcopy (30 of 31 HPV-positive and 10 of 219 HPV-negative women), sensitivity for a positive colposcopy was 93.3% (95% CI: 77.9% - 99.2%) and specificity 80.0% (44.4% - 97.5%). Among the 15 women with paired histopathology, sensitivity for CIN1+ was 92.3% (64.0% - 99.8%) and specificity 50.0% (1.3% - 98.7%); for CIN2+, sensitivity was 88.9% (51.8% - 99.7%) and specificity 16.7% (0.4% - 64.1%). Because reference testing was performed almost exclusively in HPV-positive women, these estimates are subject to verification bias and are likely to overestimate sensitivity. HPV positivity was significantly associated with socioeconomic category, educational level, number of sexual partners, abnormal uterine bleeding, and post-coital bleeding. Conclusion: In this single-centre study, point-of-care Truenat testing was feasible and was linked to colposcopy and treatment of HPV-positive women. Because the assay detects only four high-risk HPV genotypes and its clinical performance was estimated in small, selectively verified subsets, these findings do not establish its performance as a general high-risk HPV primary screening test. Larger studies with verification of test-negative women are required.