Safety and acceptability of human papillomavirus testing of self-collected specimens: A methodologic study of the impact of collection devices and HPV assays on sensitivity for cervical cancer and high-grade lesions

• Published in: Journal of clinical virology Vol. 99-100; pp. 22 - 30
• Main Authors: Leinonen, Maarit K., Schee, Kristina, Jonassen, Christine M., Lie, A. Kathrine, Nystrand, Camilla F., Rangberg, Anbjørg, Furre, Ingegerd E., Johansson, Marzena J., Tropé, Ameli, Sjøborg, Katrine D., Castle, Philip E., Nygård, Mari
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01-02-2018
• Subjects: Acceptability; Adult; Cervical Intraepithelial Neoplasia - diagnosis; Device; Female; HPV test; Humans; Papillomaviridae; Papillomavirus Infections - diagnosis; Reagent Kits, Diagnostic; Safety; Self Administration; Self-sampling; Sensitivity and Specificity; Uterine Cervical Neoplasms - diagnosis; Vaginal smear; Vaginal Smears - instrumentation; Vaginal Smears - standards; PPA; ASC-US; PNA; OUH; HPV test; CI; Device; ØHT; LSIL; hrHPV; Acceptability; HSIL; Self-sampling; ACIS; CIN3; CIN2; ASC-H; CIN1; AGUS; Vaginal smear; Performance; CRN
• ISSN: 1386-6532; 1873-5967
• DOI: 10.1016/j.jcv.2017.12.008

•Self-collection is comparable to current practice for detecting cervical lesions.•Collection devices may have impact on disease detection and on acceptability.•Delays in specimen preparation can notably affect the performance of self-collection.•Only validated procedure should be used and any delays should be minimized.
Comparative data on different self-collection methods is limited.
To assess the impact of hrHPV testing of two self-collection devices for detection of cervical carcinoma and high-grade lesions.
Three hundred ten patients collected two cervicovaginal specimens using a brush (Evalyn®Brush) and a swab (FLOQSwabs™), and filled a questionnaire at home. Then, a physician at the clinic took a cervical specimen into PreservCyt® buffer for hrHPV testing and cytology. All specimens were tested using Anyplex™ II HPV28, Cobas® 4800 HPV Test and Xpert®HPV.
Performance comparison included 45 cervical carcinomas and 187 patients with premalignant lesions. Compared to the physician-specimen, hrHPV testing of Evalyn®Brush showed non-inferior sensitivity for CIN3+ (relative sensitivity of Anyplex™ 0.99; Cobas® 0.96; Xpert®HPV 0.97) while hrHPV testing of FLOQSwabs™ showed inferior sensitivity (relative sensitivity of Anyplex™ 0.91; Cobas® 0.92; Xpert®HPV 0.93). Similar results were observed for invasive carcinomas albeit that FLOQSwabs™ was statistically non-inferior to the physician-specimen. Self-collection by either Evalyn®Brush or FLOQSwabs™ was more sensitive for CIN3+ than LSIL or worse cytology. Significant decrease in sensitivity for CIN3+ were observed for FLOQSwabs™ when specimens were preprocessed for hrHPV testing after 28 days. Both devices were well accepted, but patients considered Evalyn®Brush easier and more comfortable than FLOQSwabs™.
Self-collection is comparable to current screening practice for detecting cervical carcinoma and CIN3+ but device and specimen processing effects exist. Only validated procedure including collection device, hrHPV assay and specimen preparation should be used.