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Cited by 2Cervical Cancer and HPV ResearchWomen's cancer prevention and managementReproductive tract infections research

Performance of HPV Self-Sample Collected by a Novel Kit in Comparison with Clinician Collected Sample for Cervical Cancer Screening

Open access
Joshi, Smita, Kumar, B Kishore, Ramshankar, Vijayalakshmi, Maitra, Nandita, Palit, Sayantani, Ravindran, Soundharya, Shyam, Twinkle·2024·Asian Pacific Journal of Cancer Prevention
DOI 10.31557/apjcp.2024.25.12.4211PMC PMC12008359
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Abstract

BACKGROUND AND OBJECTIVES: We are reporting the performance of HPV self-sample collected by a novel kit in comparison with clinician collected cervical sample for HPV testing for cervical cancer screening. METHODS: Consenting, eligible women aged 25 to 60, with a positive cervical cancer screening test report in the past one year but without any prior treatment for cervical abnormalities were enrolled in the study. Each woman provided 2 samples for the HPV test (vaginal self-sample collected with the CERVICHECKTM, an indigenous kit from India and cervical sample collected by the clinician). These samples were analysed using cobas HPV test on 4800 platform and for liquid-based cytology. RESULTS: We enrolled 156 eligible, consenting participants at 2 study sites. The agreement for the sample collected by CERVICHECKTM and clinician collected sample for any high-risk HPV was 95.1% (k= 0.90, SE 0.036, 95% CI 0.83-0.97). The agreement for HPV 16 or 18 only was 95.1%, (k=0.88, SE 0.045, 95% CI 0.79-0.97). The overall acceptability of the kit was good, participants expressed that self-sampling was easy and > 90% women were willing to recommend it to their friends. INTERPRETATION AND CONCLUSIONS: There was almost perfect or perfect agreement between the HPV self-sample collected by CERVICHECKTM and clinician collected cervical sample. Self-sampling was highly acceptable to the participating women.

AI snapshot

Written from the paper’s full text.

TL;DR

In this cross-sectional study of 156 women in India, HPV self-sampling with the CERVICHECK kit showed almost perfect agreement with clinician-collected cervical samples for high-risk HPV detection and very good agreement for liquid-based cytology. Self-sampling was highly acceptable, although most participants still felt clinician sampling was better.

Key findings

  • For any high-risk HPV including HPV 16/18, agreement between self- and clinician-collected samples was 95.1% (κ=0.90, SE 0.036, 95% CI 0.83–0.97); sensitivity was 96.2% (95% CI 89.2–99.2) and specificity 93.9% (95% CI 85.2–98.3).
  • For HPV 16/18 only, agreement was 95.1% (κ=0.88, SE 0.045, 95% CI 0.79–0.97); sensitivity was 97.1% (95% CI 91.8–99.4) and specificity 90.0% (95% CI 76.3–97.2).
  • Agreement for liquid-based cytology between self- and clinician-collected samples was 95% (κ=0.80, SE 0.072, 95% CI 0.66–0.94) [Data not shown].
  • Acceptability was high: 152/152 (100%) found instructions clear, 150/152 (98.7%) reported self-sampling was easy, and 141/152 (92.8%) would recommend it to friends/family; however, 99/152 (65.1%) felt a clinician-taken sample was better, and 43/152 (28.3%) found self-sampling unpleasant.

Methods

  • Cross-sectional study at 2 sites in India (Prayas, Pune and Baroda Medical College/Sir Sayajirao General Hospital, Baroda) between 1 April 2022 and 20 September 2022.
  • 156 consenting women aged 25–60 referred for colposcopy after an abnormal cervical cancer screening test in the past year were enrolled; 4 withdrew consent and were not included in analysis. Mean age was 41.1 years (SD 6.7, range 25–58).
  • Each participant provided a vaginal self-sample using CERVICHECK and a clinician-collected cervical sample; samples were tested with cobas HPV on the 4800 platform and liquid-based cytology. Agreement was assessed with Cohen’s kappa, and sensitivity/specificity of self-sampling used clinician sampling as standard; acceptability was assessed by questionnaire.

Limitations

  • Stated: About 80% of participants (all from Site 1) had prior experience of vaginal self-sampling in a community screening program, which may have affected acceptability of the CERVICHECK kit.
  • Evident: This was a pilot cross-sectional study at two Indian sites; participants were women referred for colposcopy after abnormal prior screening, so findings may not generalize to all screening-eligible women.
  • Evident: Self-sampling was performed in clinic with a study nurse available, not by mailed/home kit; LBC agreement data are reported as not shown, and Site 2 contributed only 31 participants.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.31557/apjcp.2024.25.12.4211

Cites

0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

8 of 13 cited sources checked · 5 supported · 0 flagged · accuracy not yet measured

  • Premisecitation

    PCR-based HPV assays to detect high-risk HPVs are as accurate on HPV self-samples as on clinician-collected samples.

    “Polymerase chain reaction (PCR) based HPV assays to detect high-risk HPVs are as accurate on HPV self-samples as the clinician collected samples [8].”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [8] Arbyn M Smith SB Temin S Sultana F Castle P Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses BMJ 2018 363:k4823 PMC6278587 30518635 source
  • Premisecitation

    HPV self-sampling increases screening participation rates.

    “HPV self-sampling increases the screening participation rates [12] and thus increases the screening coverage [13].”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [12] Costa S Verberckmoes B Castle PE Arbyn M Offering HPV self-sampling kits: an updated meta-analysis of the effectiveness of strategies to increase participation in cervical cancer screening Br J Cancer 2023 128 5 805 13 36517552 PMC9977737 source
  • Premisecitation

    The acceptability of HPV self-sampling has been shown to be very good among participating women.

    “The acceptability of HPV self-sampling has been shown to be very good among participating women, the sample can be collected in their own private environment without having to visit the clinic or hospital, and self-sampling can also help women in overcoming multiple barriers [9-11].”
    Quote in the paperNot a substantial claim3 of 3 sources checked
    • cites [9] Daponte N Valasoulis G Michail G Magaliou I Daponte AI Garas A HPV-Based Self-Sampling in Cervical Cancer Screening: An Updated Review of the Current Evidence in the Literature Cancers (Basel) 2.023 15 6 1669 36980555 PMC10046242 source
    • cites [10] Baussano I Tshering S Choden T Lazzarato F Tenet V Plummer M Cervical cancer screening in rural Bhutan with the care HPV test on self-collected samples: an ongoing cross-sectional, population-based study (REACH-Bhutan) BMJ Open 2017 7 7 e016309 PMC5734451 28724543 source
    • cites [11] Sowjanya AP Paul P Vedantham H Ramakrishna G Vidyadhari D Vijayaraghavan K Suitability of self-collected vaginal samples for cervical cancer screening in periurban villages in Andhra Pradesh, India Cancer Epidemiol Biomarkers Prev 2009 18 5 1373 8 19423518 PMC2762740 source
  • Premisecitation

    HPV testing has been shown to be cost-effective in spite of its initial higher cost when compared to cytology or visual inspection of the cervix with 5% acetic acid (VIA).

    “HPV testing has been shown be cost-effective in spite of its initial higher cost when compared to cytology or visual inspection of the cervix with 5% acetic acid (VIA) [19], it is still expensive and not adapted in most of the low- and middle-income countries.”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [19] Mezei AK Armstrong HL Pedersen HN Campos NG Mitchell SM Sekikubo M Cost-effectiveness of cervical cancer screening methods in low- and middle-income countries: A systematic review Int J Cancer 2017 141 3 437 46 28297074 source

      The Discussion says HPV testing is generally more costly than VIA but often worth the extra investment. The Cost-effectiveness section says which is more efficient depends on test costs and performance; it also reports that cytology programs generally had higher costs, so the claim that HPV testing has a higher cost than cytology is not consistently supported. (LLM, conf=0.87)

      Experimental — accuracy not yet measured
  • Findingown data

    The specificity of the CERVICHECK self-sample for detection of any high-risk HPV was 93.9% (95% CI 85.2-98.3).

    “The sensitivity of the kit for the detection of any high-risk HPV was 96.2% (95% CI 89.2-99.2) and specificity of 93.9% (95% CI 85.2-98.3).”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim. 12

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    HPV vaccination of adolescent girls will help reduce cervical cancer incidence in low- and middle-income countries by more than 85% over the next century.

    “Although HPV vaccination of adolescent girls will help in reducing cervical cancer incidence in low- and middle-income countries (LMICs) by more than 85% over the next century [4], adult women who do not benefit by the preventive HPV vaccines need immediate intervention of cervical cancer screening and appropriate management of pre-cancers to prevent cervical cancers.”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [4] Brisson M Kim JJ Canfell K Drolet M Gingras G Burger EA Impact of HPV vaccination and cervical screening on cervical cancer elimination: a comparative modelling analysis in 78 low-income and lower-middle-income countries Lancet 2020 395 10224 575 32007141 PMC7043009 source

      The Results project an 89.4% reduction in cervical cancer incidence over the next century with girls-only HPV vaccination, supporting the claimed magnitude. That projection assumes 90% vaccination coverage, and the study covers low-income and lower-middle-income countries rather than all middle-income countries; the citing sentence omits those limits. (LLM, conf=0.82)

      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    In developed countries where screening programmes are in place, most cervical cancers are seen in women who have never been screened.

    “In the developed countries where screening programmes are in place, most cervical cancers are seen in women who have never been screened [17].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [17] Pierce Campbell CM Menezes LJ Paskett ED Giuliano AR Prevention of invasive cervical cancer in the United States: past, present, and future Cancer Epidemiol Biomarkers Prev 2012 21 9 1402 8 22556273 PMC3556792 source

      The Disparities and the Excess Burden of Cervical Cancer section (page unavailable) says that more than 60% of U.S. cases occur in underserved populations, who are less likely to undergo screening. The Cervical Cancer Screening section also links excess cancer burden to screening underuse. Neither passage says that most patients have never been screened, or establishes that pattern across developed countries. (LLM, conf=0.82)

      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    All participants found that the instructions for using the self-sampling kit were clear (152/152, 100%, 95% CI 97.6-100).

    “All the participants found that the instructions for using the self-sampling kit were clear (152/152, 100%, 95% CI 97.6-100).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    145/152 (95.4%, 95% CI 90.7-98.1) felt that self-sample will be opted by women who are uncomfortable to provide a sample at the clinic.

    “145/152 (95.4%, 95% CI 90.7-98.1) felt that self-sample will be opted by women who are uncomfortable to provide a sample at the clinic.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Of the 125 participants enrolled at Site 1, 119 had prior experience of vaginal self-sample for the HPV test.

    “Of the 125 participants enrolled at Site 1, 119 had prior experience of vaginal self-sample for the HPV test when they were screened previously with the Hybrid Capture 2 test using HPV self-samples in different outreach screening camps and since they were HPV positive, they were referred for colposcopy when they were enrolled in this study.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    A sample size of 150 participants was powered to detect substantial agreement (κ=0.80) between self- and physician-collected specimens with a 5% significance level.

    “A sample size of 150 participants was powered to detect substantial agreement (κ=0.80) between self- and physician-collected specimen with a 5% significance level.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    WHO recommends HPV detection in its 2021 guidelines.

    “Several randomized controlled trials and cross-sectional studies including a meta-analysis have shown that human papillomavirus (HPV) detection is the most superior primary screening test for detection of cervical intraepithelial neoplasia (CIN) [5] and is also recommended by the WHO in the 2021 guidelines [3].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [3] WHO [cited 2023 Apr 25] Cervical Cancer Elimination Initiative Available from: https://www.who.int/initiatives/cervical-cancer-elimination-initiative

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The vials were assigned unique sample tracking numbers masked to eliminate bias at the testing laboratory.

    “The vials were assigned a unique sample tracking number masked to eliminate bias at the testing laboratory.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable).

    Premisecitation

    Screening with the HPV test offers a unique opportunity for HPV self-sampling.

    “Screening with the HPV test offers a unique opportunity for HPV-self sampling [7].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [7] Snijders PJF Verhoef VMJ Arbyn M Ogilvie G Minozzi S Banzi R High-risk HPV testing on self-sampled versus clinician-collected specimens: a review on the clinical accuracy and impact on population attendance in cervical cancer screening Int J Cancer 2013 132 10 2223 36 22907569 source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Four participants withdrew consent and were not included in the analysis.

    “Four participants withdrew consent hence they are not included in the analysis.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The overall acceptability of vaginally administered products has been reported to be very good among Indian women previously.

    “The overall acceptability of vaginally administered products has been reported to be very good among Indian women previously [24] however we are not sure if the mailing of HPV self-sample kits will work in India due to the illiteracy and lack of awareness of this cervical cancer screening approach which has worked well in the developed countries [25].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [24] Joglekar NS Joshi SN Deshpande SS Parkhe AN Katti UR Mehendale SM Acceptability and adherence: findings from a Phase II study of a candidate vaginal microbicide, “Praneem polyherbal tablet”, in Pune, India Trans R Soc Trop Med Hyg 2010 104 6 412 5 20096909 source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The study was approved by the ethics committees of both institutes.

    “The study was approved by the ethics committees of both the institutes.”
    Quote in the paperNot a substantial claim
12 of 12

  • The paper relies on this without support.

    Self-sampling devices are not readily available in low- and middle-income countries including India and are currently expensive.

    “However, the self-sampling devices are not readily available in the low- and middle-income countries including India and are currently expensive.”

  • The paper relies on this without support.

    HPV self-sampling can help in reaching the never screened or hard-to-reach population and is convenient to the health care facility by reducing the logistics and additional costs associated with cervical sample collection.

    “HPV self-sampling can help in reaching the never screened or hard to reach population and it is also convenient to the health care facility by reducing the logistics and additional costs associated with cervical sample collection.”

  • The paper relies on this without support.

    HPV self-sampling is not recommended for collection of cervical cells for cytology because the necessary scraping of the squamocolumnar junction/transformation zone and the endocervical canal cannot be ensured with a blind procedure.

    “HPV self-sampling method is not recommended for collection of cervical cells for cytology since the necessary scraping of the squamocolumnar junction / transformation zone as well as the endocervical canal cannot be ensured with a blind procedure.”
3 of 3

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Identical zero-response groups have conflicting confidence intervals

    Minor

    Table 4 gives a 0-0.02% confidence interval for zero of 152 responses to one question, but a 0.0-2.4% interval for zero of 152 responses to another.

  • Nulliparous percentage is incorrect

    Minor

    One of 156 participants is 0.6%, not 0.0%.

    Reported 0 · recomputed 0.641026

  • LBC kappa is called very good despite the paper's stated cutoff

    Minor

    The methods classify κ=0.80 as "Good" and reserve "Very good" for κ≥0.81, but the discussion calls the LBC agreement very good at κ=0.80.

  • Discussion mistakes agreement percentage for kappa

    Minor

    The discussion reports k=95.1 for both HPV comparisons, whereas the results report kappas of 0.90 and 0.88; 95.1% is the reported agreement rate.

4 of 4

Cites

The publisher hasn’t deposited this paper’s reference list.

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Related

Authors
Joshi, S., Kumar, B. K., Ramshankar, V., Maitra, N., Palit, S., Ravindran, S., & Shyam, T.
Affiliations
  • Cancer Institute (WIA) (IN)
  • Sir Sayajirao General Hospital Medical College (IN)
ORCID
Venue
Asian Pacific Journal of Cancer Prevention
Publisher
EpiSmart Science Vector Ltd
Published
2024-12-01
Volume
25
Issue
12
Pages
4211-4216
ISSN
  • 1513-7368 (ISSN-L)
  • 2476-762X
DOI
10.31557/apjcp.2024.25.12.4211
PMC
PMC12008359
OpenAlex
W4405874690
Semantic Scholar
1a5e63824f7501e3033764aa5501ea3dfe46e05c
Cited by
2
References
0
Citations by year
2026: 2
FWCI
0.53
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • Asian Pacific Journal of Cancer Prevention (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • PubMed Central (submittedVersion, cc-by-nc)
Funders
Biotechnology Industry Research Assistance Council
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
HPV self-sampling, cervical cancer screening, high-risk HPV, HPV 16/18, acceptability, liquid-based cytology, cobas HPV test
MeSH terms
Adult, Uterine Cervical Neoplasms, DNA, Viral, Female, Follow-Up Studies, Humans, Middle Aged, Prognosis, Reagent Kits, Diagnostic, Specimen Handling, Vaginal Smears, Papillomaviridae, Papillomavirus Infections, Early Detection of Cancer

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