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Abstract
Objective New rapid and low-cost molecular tests for cervical cancer screening, such as the OncoE6 Cervical Test, are emerging and could be alternatives for low-income and middle-income countries. To this end, we evaluated the clinical performance of the OncoE6 Cervical Test in detecting cervical intraepithelial neoplasia (CIN) among HIV-infected women in Bujumbura, Burundi.
Methods From June to December 2017, a cross-sectional study was conducted in 680 HIV-positive women at the University Hospital. Women aged 25–65 years who declared having had vaginal intercourse were consecutively recruited, and cervical specimens for OncoE6, liquid-based cytology and human papillomavirus (HPV) genotyping were obtained and visual inspection with acetic acid performed. Thereafter, participants underwent a colposcopic examination. The sensitivity, specificity, and positive and negative predictive values of the different tests were calculated with reference to ‘colposcopic-histological’ diagnoses, and areas under the receiver operating curves of OncoE6 and cytology tests were compared.
Results The prevalence of CIN was 4.9%, and OncoE6 positivity was 3.1%. OncoE6 sensitivity varied from poor to low with increasing disease severity (42.1%, 95% CI 19.9% to 64.3% at CIN2+ threshold; and 58.3%, 95% CI 30.4% to 86.2% at CIN3+ threshold). OncoE6 had the highest specificity compared with all other tests used together. The performance of the OncoE6 test was significantly lower compared with cytology at atypical squamous cell of undetermined significance (ASCUS+) cut-off (AUC=0.68 vs 0.85, p=0.03) and low-grade squamous intraepithelial lesion (LSIL+) cut-off (AUC=0.68 vs 0.83, p=0.04) for CIN2+ diagnoses. However, the performance of the OncoE6 test was similar to that of cytology at high-grade squamous intraepithelial lesion (HSIL+) cut-off (AUC=0.68 vs 0.76; p=0.30) for CIN2+ diagnoses and was also similar to that of cytology at all cut-offs (ASCUS+, LSIL+ and HSIL+) for CIN3+ diagnoses (p1=0.76, p2=0.95 and p3=0.50, respectively).
Conclusion The current OncoE6 test proved to be a point-of-care test. However, given its poor performance for CIN2+ diagnoses, we do not recommend it for primary screening. We recommend to enrich it with more oncogenic HPV types, which may improve the performance of the test akin to that of cytology.
- epidemiology
- HIV & AIDS
- Cervical cancer
- screening
- OncoE6TM Cervical Test
- OncoE6 performance
- Burundi
- HPV
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Footnotes
Contributors ZN, J-PVG and DVB contributed equally to the study conception and design. ZN coordinated the study, collected data, analysed data, interpreted the results, wrote and edited the manuscript, and validated the final version. J-PVG: data analysis, interpretation of results, review and approval of the final version. DVB: interpreted the results, reviewed and approved the final version. SM: analysed the data, and wrote, edited and approved the final manuscript. YJ: interpreted the results, and reviewed and approved the final version. CS: interpretation, editing and validation of the final version. J-PB and IB: interpretation and validation of the final version.
Funding This study was funded by the IUC-VLIR-UOS/UB (grant number BI12017IUC022A102). The funding agency had no role in the study design, data collection, analysis, interpretation and writing of this manuscript.
Competing interests None declared.
Patient consent for publication Obtained.
Ethics approval The study protocol was approved by the Burundian National Ethics Committee. Participants were informed about the study objectives and all the steps for specimen collection. Participation was entirely voluntary and an informed consent was signed by all the participants before being enrolled in the study. The informed consent form was translated to Kirundi, a local language spoken and understood by all study participants.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request.