Improved sensitivity of vaginal self-collection and high-risk human papillomavirus testing

Jerome L. Belinson, Hui Du, Bin Yang, Ruifang Wu, Suzanne E. Belinson, Xinfeng Qu, Robert G. Pretorius, Xin Yi, Philip E. Castle

Research output: Contribution to journalArticle

70 Citations (Scopus)

Abstract

Self-collected vaginal specimens tested for high-risk human papillomavirus (HR-HPV) have been shown to be less sensitive for the detection of cervical intraepithelial neoplasia or cancer (≤yen;CIN 3) than physician-collected endocervical specimens. To increase the sensitivity of self-collected specimens, we studied a self-sampling device designed to obtain a larger specimen from the upper vagina (POI/NIH self-sampler) and a more sensitive polymerase chain reaction (PCR)-based HR-HPV assay. Women (10,000) were screened with cervical cytology and HR-HPV testing of vaginal self-collected and endocervical physician-collected specimens. Women were randomly assigned to use either a novel self-collection device (POI/NIH self-sampler) or conical-shaped brush (Qiagen). The self-collected and clinician-collected specimens were assayed by Cervista (Hologic) and the research only PCR-based matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF). Women with any abnormal screening test underwent colposcopy and biopsy. Women (8,556), mean age of 38.9, had complete data; 1.6% had ≤yen; CIN 3. For either HR-HPV assay, the sensitivity was similar for the two self-collection devices. Tested with Cervista, the sensitivity for ≤yen;CIN 3 of self-collected specimens was 70.9% and for endocervical specimens was 95.0% (p = 0.0001). Tested with MALDI-TOF, the sensitivity for ≤yen;CIN 3 of self-collected specimens was 94.3% and for endocervical specimens was also 94.3% (p = 1.0). A self-collected sample using a PCR-based assay with the capability of very high throughput has similar sensitivity as a direct endocervical specimen obtained by a physician. Large population-based screening "events" in low-resource settings could be achieved by promoting self-collection and centralized high-throughput, low-cost testing by PCR-based MALDI-TOF.

Original languageEnglish (US)
Pages (from-to)1855-1860
Number of pages6
JournalInternational Journal of Cancer
Volume130
Issue number8
DOIs
StatePublished - Apr 15 2012
Externally publishedYes

Fingerprint

Polymerase Chain Reaction
Lasers
Physicians
Equipment and Supplies
Colposcopy
Cervical Intraepithelial Neoplasia
Vagina
Cell Biology
Biopsy
Costs and Cost Analysis
Research
Population
Neoplasms

Keywords

  • cervical cancer
  • HPV
  • screening
  • self-collection

ASJC Scopus subject areas

  • Medicine(all)
  • Oncology
  • Cancer Research

Cite this

Improved sensitivity of vaginal self-collection and high-risk human papillomavirus testing. / Belinson, Jerome L.; Du, Hui; Yang, Bin; Wu, Ruifang; Belinson, Suzanne E.; Qu, Xinfeng; Pretorius, Robert G.; Yi, Xin; Castle, Philip E.

In: International Journal of Cancer, Vol. 130, No. 8, 15.04.2012, p. 1855-1860.

Research output: Contribution to journalArticle

Belinson, JL, Du, H, Yang, B, Wu, R, Belinson, SE, Qu, X, Pretorius, RG, Yi, X & Castle, PE 2012, 'Improved sensitivity of vaginal self-collection and high-risk human papillomavirus testing', International Journal of Cancer, vol. 130, no. 8, pp. 1855-1860. https://doi.org/10.1002/ijc.26202
Belinson, Jerome L. ; Du, Hui ; Yang, Bin ; Wu, Ruifang ; Belinson, Suzanne E. ; Qu, Xinfeng ; Pretorius, Robert G. ; Yi, Xin ; Castle, Philip E. / Improved sensitivity of vaginal self-collection and high-risk human papillomavirus testing. In: International Journal of Cancer. 2012 ; Vol. 130, No. 8. pp. 1855-1860.
@article{2e2eaf9592624250986180c85c57789b,
title = "Improved sensitivity of vaginal self-collection and high-risk human papillomavirus testing",
abstract = "Self-collected vaginal specimens tested for high-risk human papillomavirus (HR-HPV) have been shown to be less sensitive for the detection of cervical intraepithelial neoplasia or cancer (≤yen;CIN 3) than physician-collected endocervical specimens. To increase the sensitivity of self-collected specimens, we studied a self-sampling device designed to obtain a larger specimen from the upper vagina (POI/NIH self-sampler) and a more sensitive polymerase chain reaction (PCR)-based HR-HPV assay. Women (10,000) were screened with cervical cytology and HR-HPV testing of vaginal self-collected and endocervical physician-collected specimens. Women were randomly assigned to use either a novel self-collection device (POI/NIH self-sampler) or conical-shaped brush (Qiagen). The self-collected and clinician-collected specimens were assayed by Cervista (Hologic) and the research only PCR-based matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF). Women with any abnormal screening test underwent colposcopy and biopsy. Women (8,556), mean age of 38.9, had complete data; 1.6{\%} had ≤yen; CIN 3. For either HR-HPV assay, the sensitivity was similar for the two self-collection devices. Tested with Cervista, the sensitivity for ≤yen;CIN 3 of self-collected specimens was 70.9{\%} and for endocervical specimens was 95.0{\%} (p = 0.0001). Tested with MALDI-TOF, the sensitivity for ≤yen;CIN 3 of self-collected specimens was 94.3{\%} and for endocervical specimens was also 94.3{\%} (p = 1.0). A self-collected sample using a PCR-based assay with the capability of very high throughput has similar sensitivity as a direct endocervical specimen obtained by a physician. Large population-based screening {"}events{"} in low-resource settings could be achieved by promoting self-collection and centralized high-throughput, low-cost testing by PCR-based MALDI-TOF.",
keywords = "cervical cancer, HPV, screening, self-collection",
author = "Belinson, {Jerome L.} and Hui Du and Bin Yang and Ruifang Wu and Belinson, {Suzanne E.} and Xinfeng Qu and Pretorius, {Robert G.} and Xin Yi and Castle, {Philip E.}",
year = "2012",
month = "4",
day = "15",
doi = "10.1002/ijc.26202",
language = "English (US)",
volume = "130",
pages = "1855--1860",
journal = "International Journal of Cancer",
issn = "0020-7136",
publisher = "Wiley-Liss Inc.",
number = "8",

}

TY - JOUR

T1 - Improved sensitivity of vaginal self-collection and high-risk human papillomavirus testing

AU - Belinson, Jerome L.

AU - Du, Hui

AU - Yang, Bin

AU - Wu, Ruifang

AU - Belinson, Suzanne E.

AU - Qu, Xinfeng

AU - Pretorius, Robert G.

AU - Yi, Xin

AU - Castle, Philip E.

PY - 2012/4/15

Y1 - 2012/4/15

N2 - Self-collected vaginal specimens tested for high-risk human papillomavirus (HR-HPV) have been shown to be less sensitive for the detection of cervical intraepithelial neoplasia or cancer (≤yen;CIN 3) than physician-collected endocervical specimens. To increase the sensitivity of self-collected specimens, we studied a self-sampling device designed to obtain a larger specimen from the upper vagina (POI/NIH self-sampler) and a more sensitive polymerase chain reaction (PCR)-based HR-HPV assay. Women (10,000) were screened with cervical cytology and HR-HPV testing of vaginal self-collected and endocervical physician-collected specimens. Women were randomly assigned to use either a novel self-collection device (POI/NIH self-sampler) or conical-shaped brush (Qiagen). The self-collected and clinician-collected specimens were assayed by Cervista (Hologic) and the research only PCR-based matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF). Women with any abnormal screening test underwent colposcopy and biopsy. Women (8,556), mean age of 38.9, had complete data; 1.6% had ≤yen; CIN 3. For either HR-HPV assay, the sensitivity was similar for the two self-collection devices. Tested with Cervista, the sensitivity for ≤yen;CIN 3 of self-collected specimens was 70.9% and for endocervical specimens was 95.0% (p = 0.0001). Tested with MALDI-TOF, the sensitivity for ≤yen;CIN 3 of self-collected specimens was 94.3% and for endocervical specimens was also 94.3% (p = 1.0). A self-collected sample using a PCR-based assay with the capability of very high throughput has similar sensitivity as a direct endocervical specimen obtained by a physician. Large population-based screening "events" in low-resource settings could be achieved by promoting self-collection and centralized high-throughput, low-cost testing by PCR-based MALDI-TOF.

AB - Self-collected vaginal specimens tested for high-risk human papillomavirus (HR-HPV) have been shown to be less sensitive for the detection of cervical intraepithelial neoplasia or cancer (≤yen;CIN 3) than physician-collected endocervical specimens. To increase the sensitivity of self-collected specimens, we studied a self-sampling device designed to obtain a larger specimen from the upper vagina (POI/NIH self-sampler) and a more sensitive polymerase chain reaction (PCR)-based HR-HPV assay. Women (10,000) were screened with cervical cytology and HR-HPV testing of vaginal self-collected and endocervical physician-collected specimens. Women were randomly assigned to use either a novel self-collection device (POI/NIH self-sampler) or conical-shaped brush (Qiagen). The self-collected and clinician-collected specimens were assayed by Cervista (Hologic) and the research only PCR-based matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF). Women with any abnormal screening test underwent colposcopy and biopsy. Women (8,556), mean age of 38.9, had complete data; 1.6% had ≤yen; CIN 3. For either HR-HPV assay, the sensitivity was similar for the two self-collection devices. Tested with Cervista, the sensitivity for ≤yen;CIN 3 of self-collected specimens was 70.9% and for endocervical specimens was 95.0% (p = 0.0001). Tested with MALDI-TOF, the sensitivity for ≤yen;CIN 3 of self-collected specimens was 94.3% and for endocervical specimens was also 94.3% (p = 1.0). A self-collected sample using a PCR-based assay with the capability of very high throughput has similar sensitivity as a direct endocervical specimen obtained by a physician. Large population-based screening "events" in low-resource settings could be achieved by promoting self-collection and centralized high-throughput, low-cost testing by PCR-based MALDI-TOF.

KW - cervical cancer

KW - HPV

KW - screening

KW - self-collection

UR - http://www.scopus.com/inward/record.url?scp=82255190119&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=82255190119&partnerID=8YFLogxK

U2 - 10.1002/ijc.26202

DO - 10.1002/ijc.26202

M3 - Article

C2 - 21630255

AN - SCOPUS:82255190119

VL - 130

SP - 1855

EP - 1860

JO - International Journal of Cancer

JF - International Journal of Cancer

SN - 0020-7136

IS - 8

ER -