Can human papillomavirus DNA testing of self-collected vaginal samples compare with physician-collected cervical samples and cytology for cervical cancer screening in developing countries?

Neerja Bhatla, Lalit Dar, A. Rajkumar Patro, Pankaj Kumar, Alka Kriplani, Arti Gulati, Venkateswaran K. Iyer, Sandeep R. Mathur, Vishnubhatla Sreenivas, Keerti V. Shah, Patti E. Gravitt

Research output: Contribution to journalArticle

Abstract

Background: To determine human papillomavirus (HPV) types by polymerase chain reaction (PCR)-reverse line blot assay and examine the concordance between HPV by Hybrid Capture 2 (HC2) and PCR on self-collected vaginal and physician-collected cervical samples and cytology. Methods: This was a cross-sectional study of 546 sexually active women aged ≥30 years with persistent vaginal discharge, intermenstrual or postcoital bleeding or an unhealthy cervix. Participants self-collected vaginal samples (HPV-S) and physicians collected cervical samples for conventional Pap smear and HPV DNA (HPV-P) testing and performed colposcopy, with directed biopsy, if indicated. HPV testing and genotyping was done by HC2 and PCR reverse line blot assay. Concordance between HC2 and PCR results of self- and physician-collected samples was determined using a Kappa statistic (κ) and Chi-square test. Results: Complete data were available for 512 sets with 98% of women providing a satisfactory self-sample. PCR detected oncogenic HPV in 12.3% of self- and 13.0% of physician-collected samples. Overall, there was 93.8% agreement between physician-collected and self-samples (κ = 76.31%, 95% confidence interval [CI]: 64.97-82.29%, p = 0.04)-complete concordance in 473 cases (57 positive, 416 negative), partial concordance in seven pairs and discordance in 32 pairs. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of self-sampling for detection of cervical intraepithelial neoplasia (CIN)2+ disease were 82.5%, 93.6%, 52.4% and 98.4%, respectively; for physician-sampling they were 87.5%, 93.2%, 52.2% and 98.9%, respectively; and for cytology they were 77.5%, 87.3%, 34.1% and 97.9%, respectively. Concordance between HC2 and PCR was 90.9% for self-samples (κ = 63.7%, 95% CI: 55.2-72.2%) and 95.3% for physician-collected samples (κ = 80.4%, 95% CI: 71.8-89.0%). Conclusions: Self-HPV sampling compares favourably with physician-sampling and cytology. A rapid, affordable, HPV self-test kit can be used as the primary method of cervical cancer screening in low-resource situations.

Original languageEnglish (US)
Pages (from-to)446-450
Number of pages5
JournalCancer Epidemiology
Volume33
Issue number6
DOIs
StatePublished - Dec 2009

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Early Detection of Cancer
Uterine Cervical Neoplasms
Developing Countries
Cell Biology
Physicians
DNA
Polymerase Chain Reaction
Confidence Intervals
Vaginal Discharge
Papanicolaou Test
Colposcopy
Cervical Intraepithelial Neoplasia
Chi-Square Distribution
Cervix Uteri
Cross-Sectional Studies
Hemorrhage
Biopsy
Sensitivity and Specificity

Keywords

  • CIN
  • Genotyping
  • HPV types
  • Hybrid Capture 2
  • PCR
  • Screening
  • Self-sampling

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Epidemiology

Cite this

Can human papillomavirus DNA testing of self-collected vaginal samples compare with physician-collected cervical samples and cytology for cervical cancer screening in developing countries? / Bhatla, Neerja; Dar, Lalit; Patro, A. Rajkumar; Kumar, Pankaj; Kriplani, Alka; Gulati, Arti; Iyer, Venkateswaran K.; Mathur, Sandeep R.; Sreenivas, Vishnubhatla; Shah, Keerti V.; Gravitt, Patti E.

In: Cancer Epidemiology, Vol. 33, No. 6, 12.2009, p. 446-450.

Research output: Contribution to journalArticle

Bhatla, Neerja ; Dar, Lalit ; Patro, A. Rajkumar ; Kumar, Pankaj ; Kriplani, Alka ; Gulati, Arti ; Iyer, Venkateswaran K. ; Mathur, Sandeep R. ; Sreenivas, Vishnubhatla ; Shah, Keerti V. ; Gravitt, Patti E. / Can human papillomavirus DNA testing of self-collected vaginal samples compare with physician-collected cervical samples and cytology for cervical cancer screening in developing countries?. In: Cancer Epidemiology. 2009 ; Vol. 33, No. 6. pp. 446-450.
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title = "Can human papillomavirus DNA testing of self-collected vaginal samples compare with physician-collected cervical samples and cytology for cervical cancer screening in developing countries?",
abstract = "Background: To determine human papillomavirus (HPV) types by polymerase chain reaction (PCR)-reverse line blot assay and examine the concordance between HPV by Hybrid Capture 2 (HC2) and PCR on self-collected vaginal and physician-collected cervical samples and cytology. Methods: This was a cross-sectional study of 546 sexually active women aged ≥30 years with persistent vaginal discharge, intermenstrual or postcoital bleeding or an unhealthy cervix. Participants self-collected vaginal samples (HPV-S) and physicians collected cervical samples for conventional Pap smear and HPV DNA (HPV-P) testing and performed colposcopy, with directed biopsy, if indicated. HPV testing and genotyping was done by HC2 and PCR reverse line blot assay. Concordance between HC2 and PCR results of self- and physician-collected samples was determined using a Kappa statistic (κ) and Chi-square test. Results: Complete data were available for 512 sets with 98{\%} of women providing a satisfactory self-sample. PCR detected oncogenic HPV in 12.3{\%} of self- and 13.0{\%} of physician-collected samples. Overall, there was 93.8{\%} agreement between physician-collected and self-samples (κ = 76.31{\%}, 95{\%} confidence interval [CI]: 64.97-82.29{\%}, p = 0.04)-complete concordance in 473 cases (57 positive, 416 negative), partial concordance in seven pairs and discordance in 32 pairs. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of self-sampling for detection of cervical intraepithelial neoplasia (CIN)2+ disease were 82.5{\%}, 93.6{\%}, 52.4{\%} and 98.4{\%}, respectively; for physician-sampling they were 87.5{\%}, 93.2{\%}, 52.2{\%} and 98.9{\%}, respectively; and for cytology they were 77.5{\%}, 87.3{\%}, 34.1{\%} and 97.9{\%}, respectively. Concordance between HC2 and PCR was 90.9{\%} for self-samples (κ = 63.7{\%}, 95{\%} CI: 55.2-72.2{\%}) and 95.3{\%} for physician-collected samples (κ = 80.4{\%}, 95{\%} CI: 71.8-89.0{\%}). Conclusions: Self-HPV sampling compares favourably with physician-sampling and cytology. A rapid, affordable, HPV self-test kit can be used as the primary method of cervical cancer screening in low-resource situations.",
keywords = "CIN, Genotyping, HPV types, Hybrid Capture 2, PCR, Screening, Self-sampling",
author = "Neerja Bhatla and Lalit Dar and Patro, {A. Rajkumar} and Pankaj Kumar and Alka Kriplani and Arti Gulati and Iyer, {Venkateswaran K.} and Mathur, {Sandeep R.} and Vishnubhatla Sreenivas and Shah, {Keerti V.} and Gravitt, {Patti E.}",
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T1 - Can human papillomavirus DNA testing of self-collected vaginal samples compare with physician-collected cervical samples and cytology for cervical cancer screening in developing countries?

AU - Bhatla, Neerja

AU - Dar, Lalit

AU - Patro, A. Rajkumar

AU - Kumar, Pankaj

AU - Kriplani, Alka

AU - Gulati, Arti

AU - Iyer, Venkateswaran K.

AU - Mathur, Sandeep R.

AU - Sreenivas, Vishnubhatla

AU - Shah, Keerti V.

AU - Gravitt, Patti E.

PY - 2009/12

Y1 - 2009/12

N2 - Background: To determine human papillomavirus (HPV) types by polymerase chain reaction (PCR)-reverse line blot assay and examine the concordance between HPV by Hybrid Capture 2 (HC2) and PCR on self-collected vaginal and physician-collected cervical samples and cytology. Methods: This was a cross-sectional study of 546 sexually active women aged ≥30 years with persistent vaginal discharge, intermenstrual or postcoital bleeding or an unhealthy cervix. Participants self-collected vaginal samples (HPV-S) and physicians collected cervical samples for conventional Pap smear and HPV DNA (HPV-P) testing and performed colposcopy, with directed biopsy, if indicated. HPV testing and genotyping was done by HC2 and PCR reverse line blot assay. Concordance between HC2 and PCR results of self- and physician-collected samples was determined using a Kappa statistic (κ) and Chi-square test. Results: Complete data were available for 512 sets with 98% of women providing a satisfactory self-sample. PCR detected oncogenic HPV in 12.3% of self- and 13.0% of physician-collected samples. Overall, there was 93.8% agreement between physician-collected and self-samples (κ = 76.31%, 95% confidence interval [CI]: 64.97-82.29%, p = 0.04)-complete concordance in 473 cases (57 positive, 416 negative), partial concordance in seven pairs and discordance in 32 pairs. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of self-sampling for detection of cervical intraepithelial neoplasia (CIN)2+ disease were 82.5%, 93.6%, 52.4% and 98.4%, respectively; for physician-sampling they were 87.5%, 93.2%, 52.2% and 98.9%, respectively; and for cytology they were 77.5%, 87.3%, 34.1% and 97.9%, respectively. Concordance between HC2 and PCR was 90.9% for self-samples (κ = 63.7%, 95% CI: 55.2-72.2%) and 95.3% for physician-collected samples (κ = 80.4%, 95% CI: 71.8-89.0%). Conclusions: Self-HPV sampling compares favourably with physician-sampling and cytology. A rapid, affordable, HPV self-test kit can be used as the primary method of cervical cancer screening in low-resource situations.

AB - Background: To determine human papillomavirus (HPV) types by polymerase chain reaction (PCR)-reverse line blot assay and examine the concordance between HPV by Hybrid Capture 2 (HC2) and PCR on self-collected vaginal and physician-collected cervical samples and cytology. Methods: This was a cross-sectional study of 546 sexually active women aged ≥30 years with persistent vaginal discharge, intermenstrual or postcoital bleeding or an unhealthy cervix. Participants self-collected vaginal samples (HPV-S) and physicians collected cervical samples for conventional Pap smear and HPV DNA (HPV-P) testing and performed colposcopy, with directed biopsy, if indicated. HPV testing and genotyping was done by HC2 and PCR reverse line blot assay. Concordance between HC2 and PCR results of self- and physician-collected samples was determined using a Kappa statistic (κ) and Chi-square test. Results: Complete data were available for 512 sets with 98% of women providing a satisfactory self-sample. PCR detected oncogenic HPV in 12.3% of self- and 13.0% of physician-collected samples. Overall, there was 93.8% agreement between physician-collected and self-samples (κ = 76.31%, 95% confidence interval [CI]: 64.97-82.29%, p = 0.04)-complete concordance in 473 cases (57 positive, 416 negative), partial concordance in seven pairs and discordance in 32 pairs. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of self-sampling for detection of cervical intraepithelial neoplasia (CIN)2+ disease were 82.5%, 93.6%, 52.4% and 98.4%, respectively; for physician-sampling they were 87.5%, 93.2%, 52.2% and 98.9%, respectively; and for cytology they were 77.5%, 87.3%, 34.1% and 97.9%, respectively. Concordance between HC2 and PCR was 90.9% for self-samples (κ = 63.7%, 95% CI: 55.2-72.2%) and 95.3% for physician-collected samples (κ = 80.4%, 95% CI: 71.8-89.0%). Conclusions: Self-HPV sampling compares favourably with physician-sampling and cytology. A rapid, affordable, HPV self-test kit can be used as the primary method of cervical cancer screening in low-resource situations.

KW - CIN

KW - Genotyping

KW - HPV types

KW - Hybrid Capture 2

KW - PCR

KW - Screening

KW - Self-sampling

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