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.

doi:10.1016/j.canep.2009.10.013

Cited by 100Cervical Cancer and HPV ResearchWomen's cancer prevention and managementReproductive tract infections research

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?

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Bhatla, Neerja, Dar, Lalit, Patro, A. Rajkumar, Kumar, Pankaj, Kriplani, Alka, Gulati, Arti, Iyer, Venkateswaran K., Mathur, Sandeep R. +3 more·2009·Cancer Epidemiology

DOI 10.1016/j.canep.2009.10.013PMC PMC3816517

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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 > or =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 (kappa) 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 (kappa=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 (kappa=63.7%, 95% CI: 55.2-72.2%) and 95.3% for physician-collected samples (kappa=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.

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Several studies comparing HPV screening results from self-collected and clinician-collected specimens in low- and middle-income countries have all demonstrated high levels of agreement.
“There have been several studies comparing HPV screening results from self-collected and clinician-collected specimens in low- and middle-income countries with all demonstrating high levels of agreement (Bhatla et al., 2009; Quincy et al., 2012; Verma and Khanna, 2013; Nilyanimit et al., 2014; Rosenbaum et al., 2014; Adamson et al., 2015; Ma’som et al., 2016).”
From Acceptability and Concordance of Self- Versus Clinician- Sampling for HPV Testing among Rural South Indian Women (2021) · cites this paper as Bhatla et al., 2009

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[6]Bhatla N Ramachandran S Virmani A Arora VK Gulati A Singla S Correlation of FastHPV and cytology: performance trial results from India Paper Presented at the 24th International Papillomavirus Conference 2007

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Authors: Bhatla, N., Dar, L., Patro, A. R., Kumar, P., Kriplani, A., Gulati, A., Iyer, V. K., Mathur, S. R., Sreenivas, V., Shah, K. V., & Gravitt, P. E.
Affiliations: All India Institute of Medical Sciences (IN)
Johns Hopkins University (US)
Corresponding author: Bhatla, Neerja
ORCID: Bhatla, Neerja
Dar, Lalit
Kumar, Pankaj
Kriplani, Alka
Iyer, Venkateswaran K.
Mathur, Sandeep R.
Sreenivas, Vishnubhatla
Gravitt, Patti E.
Venue: Cancer Epidemiology
Publisher: Elsevier BV
Published: 2009-12
Volume: 33
Issue: 6
Pages: 446-450
ISSN: 1877-7821 (ISSN-L)
DOI: 10.1016/j.canep.2009.10.013
PMC: PMC3816517
OpenAlex: W2102499315
Cited by: 99
References: 20
Citations by year: 2026: 3 · 2025: 4 · 2024: 9 · 2023: 7 · 2021: 7 · 2020: 9 · 2019: 7 · 2018: 7 · 2017: 3 · 2016: 6 · 2015: 7 · 2014: 7 · 2013: 4 · 2012: 7
FWCI: 4.27
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Cancer Epidemiology (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: National Cancer Institute (P50CA098252)
Topics: Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Women's cancer prevention and management
Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
Keywords: human papillomavirus, HPV testing, self-collected vaginal samples, cervical cancer screening, Hybrid Capture 2, cervical intraepithelial neoplasia, Pap smear cytology, test concordance, developing countries, resource-limited settings, HPV genotyping, screening sensitivity and specificity, colposcopy
MeSH terms: Adult, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Colposcopy, Cross-Sectional Studies, Developing Countries, DNA, Viral, Female, Humans, Predictive Value of Tests, Prognosis, Self Care, Sensitivity and Specificity, Vaginal Smears, Reproducibility of Results, Polymerase Chain Reaction, Papillomaviridae, Papillomavirus Infections, Papanicolaou Test

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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?

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