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

Maarit K. Leinonen, Kristina Schee, Christine M. Jonassen, A. Kathrine Lie, Camilla F. Nystrand, Anbjørg Rangberg, Ingegerd E. Furre, Marzena J. Johansson, Ameli Tropé, Katrine D. Sjøborg, Philip E. Castle, Mari Nygård

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Background Comparative data on different self-collection methods is limited. Objectives To assess the impact of hrHPV testing of two self-collection devices for detection of cervical carcinoma and high-grade lesions. Study design 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. Results 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™. Conclusions 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.

Original languageEnglish (US)
Pages (from-to)22-30
Number of pages9
JournalJournal of Clinical Virology
Volume99-100
DOIs
StatePublished - Feb 1 2018

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Uterine Cervical Neoplasms
Carcinoma
Safety
Equipment and Supplies
Physicians
Cell Biology
Buffers

Keywords

  • Acceptability
  • Device
  • HPV test
  • Performance
  • Self-sampling
  • Vaginal smear

ASJC Scopus subject areas

  • Virology
  • Infectious Diseases

Cite this

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. / 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.

In: Journal of Clinical Virology, Vol. 99-100, 01.02.2018, p. 22-30.

Research output: Contribution to journalArticle

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. / 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. In: Journal of Clinical Virology. 2018 ; Vol. 99-100. pp. 22-30.
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abstract = "Background Comparative data on different self-collection methods is limited. Objectives To assess the impact of hrHPV testing of two self-collection devices for detection of cervical carcinoma and high-grade lesions. Study design Three hundred ten patients collected two cervicovaginal specimens using a brush (Evalyn{\circledR}Brush) and a swab (FLOQSwabs™), and filled a questionnaire at home. Then, a physician at the clinic took a cervical specimen into PreservCyt{\circledR} buffer for hrHPV testing and cytology. All specimens were tested using Anyplex™ II HPV28, Cobas{\circledR} 4800 HPV Test and Xpert{\circledR}HPV. Results Performance comparison included 45 cervical carcinomas and 187 patients with premalignant lesions. Compared to the physician-specimen, hrHPV testing of Evalyn{\circledR}Brush showed non-inferior sensitivity for CIN3+ (relative sensitivity of Anyplex™ 0.99; Cobas{\circledR} 0.96; Xpert{\circledR}HPV 0.97) while hrHPV testing of FLOQSwabs™ showed inferior sensitivity (relative sensitivity of Anyplex™ 0.91; Cobas{\circledR} 0.92; Xpert{\circledR}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{\circledR}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{\circledR}Brush easier and more comfortable than FLOQSwabs™. Conclusions 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.",
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T2 - A methodologic study of the impact of collection devices and HPV assays on sensitivity for cervical cancer and high-grade lesions

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AU - Schee, Kristina

AU - Jonassen, Christine M.

AU - Lie, A. Kathrine

AU - Nystrand, Camilla F.

AU - Rangberg, Anbjørg

AU - Furre, Ingegerd E.

AU - Johansson, Marzena J.

AU - Tropé, Ameli

AU - Sjøborg, Katrine D.

AU - Castle, Philip E.

AU - Nygård, Mari

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N2 - Background Comparative data on different self-collection methods is limited. Objectives To assess the impact of hrHPV testing of two self-collection devices for detection of cervical carcinoma and high-grade lesions. Study design 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. Results 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™. Conclusions 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.

AB - Background Comparative data on different self-collection methods is limited. Objectives To assess the impact of hrHPV testing of two self-collection devices for detection of cervical carcinoma and high-grade lesions. Study design 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. Results 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™. Conclusions 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.

KW - Acceptability

KW - Device

KW - HPV test

KW - Performance

KW - Self-sampling

KW - Vaginal smear

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