Poor Performance of Applicator Tampon‐Based Self‐Collection for Liquid‐Based Cytology Among Women Attending a Tertiary Hospital in South Africa
ABSTRACT
Background
The South African Cervical Cancer Prevention and Control Policy was updated in June 2017, recommending liquid‐based cytology (LBC) as the preferred screening method and the investigation of self‐sampling for cervical cancer screening.
Aim
To compare the performance of the Self Collection Cervical Health Screening Kit [SelfCerv (applicator tampon)] to the Cervex‐Brush Combi for cytology screening. The study further aimed to compare high‐risk (hr‐) human papillomavirus (HPV) and LBC test results from both methods.
Methods
The study included 446 paired samples, comprising self‐collected (SelfCerv) and healthcare provider‐collected (Cervex‐Brush Combi) samples from women aged ≥ 18 years attending gynaecology outpatient clinics at a tertiary hospital in Pretoria, South Africa. LBC slides were prepared using the ThinPrep 5000 processor and manually stained with Hematoxylin and Eosin (H&E). Detection of 14 hr‐HPV types was performed using the Abbott RealTime HR‐HPV assay. Statistical analyses were performed using STATA version 17.0 (Stata Corp., College Station, Texas, USA).
Results
A statistically significant difference in cervical cytology detection between the two methods was observed ( p = 0.0025). The Cervex‐Brush Combi was more effective in collecting endocervical cells (73.4%; 95% CI: 69.0–77.9) compared to the SelfCerv applicator tampon (7.3%; 95% CI: 4.7–9.9); ( p < 0.001). Cytological abnormalities were detected in 65.4% (136/208) of participants who tested positive for hr‐HPV by healthcare provider sampling compared to 40.8% (84/206) by self‐sampling. A fair agreement ( κ : 0.35) with a concordance rate of 96.2% (95% CI: 94.4–98.0) was observed for specimen adequacy and diagnosis parameters [ κ : 0.34, with a concordance rate of 67.7% (95% CI: 63.2–72.1)] between the two methods.
Conclusion
The findings of this study do not support the implementation of applicator tampon‐based self‐collection as a method for cytology‐based cervical cancer screening.