Poor Performance of Applicator Tampon-Based Self-Collection for Liquid-Based Cytology Among Women Attending a Tertiary Hospital in South Africa.

Abstract

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. 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. 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). 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. 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.