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Cited by 1Cervical Cancer and HPV ResearchReproductive tract infections researchWomen's cancer prevention and management

Comparative analysis of SD biosensor standard™ M10 HPV and seegene anyplex™ II HPV HR for detecting high-risk human papillomavirus: a concordance study

Open access
Jerip, Abigail Rembui, Noni, Vaenessa, Anthony, Vanessa Kiah, Bong, Andy Cheong Shin, Adam, Jaria, Tan, Cheng Siang·2025·BMC Infectious Diseases
DOI 10.1186/s12879-025-10714-yPMC PMC11877861
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Abstract

Background: Cervical cancer, primarily caused by persistent high-risk human papillomavirus (hrHPV) infections, is a significant health burden, particularly in low-resource settings such as Sarawak, Malaysia. Effective prevention depends on effective vaccination and early hrHPV detection. This study compares the performance of the point-of-care test (POCT) SD Biosensor Standard™ M10 HPV and laboratory-based Seegene Anyplex™ II HPV HR assay, focusing on their ability to detect and genotype hrHPV in self-collected high vaginal swab samples. Methods: A total of 151 archived self-sampled high vaginal swabs from the Sarawak Urban and Rural Action for Cervical Cancer Elimination Programme ( Program SUARA ) were analyzed. hrHPV detection and genotyping were performed using Anyplex, which identifies 14 hrHPV genotypes, and M10, which detects HPV16, HPV18, and other hrHPV categorized into six genogroups. Agreement between the assays was evaluated using Cohen’s Kappa (κ), McNemar’s test, and overall agreement percentages. Statistical significance was determined with p-values, and discordant results were further analyzed for potential diagnostic implications. Results: The overall agreement between M10 and Anyplex for hrHPV detection was 92.05% (κ = 0.84, 95% CI 0.75–0.93), indicating almost perfect agreement. M10 demonstrated comparable sensitivity for detecting HPV16, HPV18, and other hrHPV genotypes, achieving 96.91% agreement (κ = 0.89, 95%CI 0.73-1.00) in hrHPV classification when discordant results were excluded. Genogrouping also showed almost perfect agreement (κ = 0.91, 95% CI 0.82–0.98). McNemar’s test indicated no significant difference in hrHPV detection rates ( p > 0.05), affirming their comparable performance in detecting clinically significant hrHPV infections. Conclusion: The SD Biosensor Standard™ M10 HPV POCT and the Seegene Anyplex™ II HPV HR assay demonstrated almost perfect agreement in hrHPV detection and classification, supporting their complementary roles in cervical cancer prevention. M10’s rapid, field-deployable design makes it suitable for resource-limited settings, while Anyplex provides enhanced genotyping capability in laboratory environments, allowing informed vaccine strategy. Incorporating both assays into cervical cancer prevention programs can improve screening coverage and accessibility, particularly in underserved areas. These findings align with the World Health Organization’s cervical cancer elimination goals, reinforcing the importance of adaptable diagnostic tools in diverse healthcare contexts.

AI snapshot

Written from the paper’s full text.

TL;DR

This concordance study compared the point-of-care SD Biosensor Standard™ M10 HPV assay with the laboratory-based Seegene Anyplex™ II HPV HR assay on 151 archived self-collected high vaginal swabs from Sarawak, Malaysia. The assays showed almost perfect agreement for hrHPV detection and genogrouping, with no significant difference in detection rates by McNemar’s test.

Key findings

  • Overall hrHPV detection agreement between M10 and Anyplex was 92.05% (κ = 0.84, 95% CI 0.75–0.93), with positive agreement 90.3% and negative agreement 93.7%; McNemar’s test was 0.77 (p > 0.05).
  • For classifying hrHPV into HPV16, HPV18, and other hrHPV, after excluding 7 discordant samples, agreement was 96.91% among 65 concordant samples (κ = 0.89, 95% CI 0.73–1.00; McNemar 0.48, p > 0.05).
  • For non-HPV16/18 genogrouping into G1–G6, among 57 samples, overall agreement was 82.5% (κ = 0.91, 95% CI 0.82–0.98; McNemar 1.0, p > 0.05).
  • Seven discordant samples on M10 were monoinfections with CTMA + HPV16 (x2), 52 (x2), 58, 39, and 51; M10 also detected 5 positives missed by Anyplex, grouped as G2 (60%), G5 (20%), and G6 (20%), with mean Ct 20.66 (SD 11.72, range 9–33), not close to the manufacturer-set negative cutoff of Ct > 39.

Methods

  • A total of 151 archived self-sampled high vaginal swabs from Program SUARA were analyzed; samples comprised 72 hrHPV-positive and 79 hrHPV-negative cases previously confirmed by Anyplex. Mean participant age was 34.35 years (SD = 7.84, range 24–64), median 33 years.
  • Anyplex detected and genotyped 14 hrHPV types (HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68); M10 qualitatively detected HPV16, HPV18, and other hrHPV, with the other 12 types semi-genotyped into six genogroups (G1–G6).
  • Agreement was assessed using Cohen’s Kappa, McNemar’s test, and overall agreement percentages in SPSS Version 27; discordant results were further analyzed for potential diagnostic implications.

Limitations

  • The paper states that despite a significant sample size, samples could be expanded in a population study to improve power, and post hoc selection of positive and negative samples may introduce bias.
  • The study focused solely on concordance between two assays without correlating hrHPV detection with cytological or histopathological outcomes; diagnostic implications of discordant cases remain uncertain without follow-up cytology or colposcopy.
  • The paper notes that actual HPV genotypes missed by Anyplex cannot be elucidated without further unbiased sequence analyses; all volunteers positive by M10 but previously negative by Anyplex were recalled for cervical examinations, and future concordance studies integrating clinical follow-up are needed.

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

Integrity signals

Registry

Crossref · 10.1186/s12879-025-10714-y

Cites

18 of 18 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

7 of 21 cited sources checked · 0 supported · 0 flagged · accuracy not yet measured

  • Interpretationcitation

    Cartridge-based POCTs may exhibit slightly lower agreement compared to laboratory-based assays.

    “These data suggest that cartridge-based POCTs may exhibit slightly lower agreement compared to laboratory-based assays [15].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [15] Arbyn M, Simon M, Peeters E, Xu L, Meijer CJLM, Berkhof J et al. 2020 list of human papillomavirus assays suitable for primary cervical cancer screening. Clinical Microbiology and Infection [Internet]. 2021 Aug 1 [cited 2024 Oct 31];27(8):1083–95. Available from: http://www.clinicalmicrobiologyandinfection.com/article/S1198743X21002196/fulltext source

      Table 3 (page unavailable in our copy) reports 96.9% intra-laboratory reproducibility for Xpert HPV, below the values listed for several other assays. It does not establish that cartridge-based point-of-care tests generally have lower agreement than laboratory-based assays; Xpert's inter-laboratory reproducibility is also higher than that of some listed assays. (LLM, conf=0.78)

      Experimental — accuracy not yet measured
  • Findingown data

    McNemar's test showed no significant difference between M10 and Anyplex in genogrouping of non-HPV16/18 hrHPV (p > 0.05).

    “The McNemar’s Test (p > 0.05) suggests no significant difference between the two assays (Table 3).”
    Quote in the paperSubstantial claim
  • Findingown data

    Two G2 samples determined by M10 had Ct < 9 and were missed by Anyplex.

    “It is worth noting that two G2 samples as determined by M10 had the Ct < 9 and were missed by Anyplex.”
    Quote in the paperNot a substantial claim
  • Findingown data

    M10 detected 5 more hrHPV positives that were not detected by Anyplex.

    “However, M10 detected 5 more positives that were not detected by Anyplex.”
    Quote in the paperSubstantial claim
  • Findingown data

    McNemar's test indicated no significant difference between M10 and Anyplex in hrHPV detection rates (p > 0.05).

    “McNemar’s test value (0.77; p > 0.05) indicates no significant difference between the assays.”
    Quote in the paperSubstantial claim
  • May combine two claims. 11
  • Classified as probably not a substantial claim. 21

  • May combine two claims.

    Premisecitation

    When Anyplex28 and Xpert HPV were evaluated against the GP5+/6+ EIA comparator HPV assay, sensitivity and specificity were 98.3% and 93.6% for Anyplex28, and 94.1% and 90.3% for Xpert HPV, respectively.

    “When Anyplex28 and Xpert HPV were evaluated against the GP5+/6 + EIA comparator HPV assay, sensitivity and specificity were 98.3% and 93.6% for Anyplex28, and 94.1%, and 90.3% for Xpert HPV, respectively [14, 15].”
    Quote in the paperNot a substantial claim2 of 2 sources checked
    • cites [14] Cuschieri K, Geraets D, Cuzick J, Cadman L, Moore C, Broeck D, Vanden et al. Performance of a cartridge-based assay for detection of clinically significant human papillomavirus (hpv) infection: Lessons from Valgent (Validation of HPV Genotyping Tests). J Clin Microbiol [Internet]. 2016 Sep 1 [cited 2024 Nov 12];54(9):2337–42. Available from: https://doi.org/10.1128/jcm.00897-16 source

      Table 2 (Discussion; page not provided) reports 94.1% sensitivity for Xpert HPV in detecting CIN2+ in the VALGENT-2 all-ages group, using GP5+/6+ EIA as the comparator. It reports 82.7% specificity for women with ≤CIN1, not 90.3%. This paper evaluates Xpert HPV; the Anyplex28 figures are not established by this source. (LLM, conf=0.92)

      Experimental — accuracy not yet measured
    • cites [15] Arbyn M, Simon M, Peeters E, Xu L, Meijer CJLM, Berkhof J et al. 2020 list of human papillomavirus assays suitable for primary cervical cancer screening. Clinical Microbiology and Infection [Internet]. 2021 Aug 1 [cited 2024 Oct 31];27(8):1083–95. Available from: http://www.clinicalmicrobiologyandinfection.com/article/S1198743X21002196/fulltext source

      Table 2 reports the stated sensitivity and specificity figures for Xpert HPV and for Anyplex II HPV HR, using a GP5+/6+ comparator. The claim calls the latter assay “Anyplex28,” but the table does not identify the assay with those figures by that name. (LLM, conf=0.88)

      Experimental — accuracy not yet measured

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

    Premisecitation

    HPV DNA testing is more sensitive than cytology in detecting precancerous lesions and cervical cancers.

    “Numerous studies affirm that HPV DNA testing is more sensitive than cytology in detecting precancerous lesions and cervical cancers [21, 22, 23] and any HPV DNA test is better than none.”
    Quote in the paperNot a substantial claim1 of 3 sources checked
    • cites [21] Thomsen LT, Kjær SK, Munk C, Ørnskov D, Waldstrøm M. Benefits and potential harms of human papillomavirus (HPV)-based cervical cancer screening: A real-world comparison of HPV testing versus cytology. Acta Obstet Gynecol Scand [Internet]. 2021 Mar 1 [cited 2024 Nov 19];100(3):394–402. Available from: https://onlinelibrary.wiley.com/doi/full/https://doi.org/10.1111/aogs.14121 source
    • cites [22] Ali M, Sinha R, kumar A, Karim S, Irfan M, Kumar S et al. HPV DNA status and clinical history of patients are supplements for accurate reporting of the cytological Pap smear. Scientific Reports 2024 14:1 [Internet]. 2024 Jul 30 [cited 2024 Nov 19];14(1):1–8. Available from: https://www.nature.com/articles/s41598-024-68344-4 source

      The Discussion (page unavailable) reports that HPV tests were significantly more sensitive than cytology for detecting CIN2+ lesions. The Results (page unavailable) found HPV 16/18 DNA in all 15 cervical cancer cases among women with negative inflammatory Pap smears, but do not establish comparative sensitivity for cervical cancer detection in a general screening population. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
    • cites [23] Liang LA, Einzmann T, Franzen A, Schwarzer K, Schauberger G, Schriefer D et al. Cervical cancer screening: Comparison of conventional pap smear test, liquid-based cytology, and human papillomavirus testing as stand-alone or cotesting strategies. Cancer Epidemiology Biomarkers and Prevention [Internet]. 2021 Mar 1 [cited 2024 Nov 20];30(3):474–84. Available from: https://doi.org/10.1158/1055-9965.EPI-20-1003 source

  • Classified as probably not a substantial claim.

    Premisecitation

    The careHPV system was reported to be less sensitive when combined with self-sampling, especially among older women.

    “Furthermore, careHPV system was reported to be less sensitive when combined with self-sampling, especially among the older women [7].”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [7] Katanga J, Kjaer SK, Manongi R, Wu C, Sen, Iftner T, Waldstrom M et al. Performance of careHPV, hybrid capture 2 and visual inspection with acetic acid for detection of high-grade cervical lesion in Tanzania: A cross-sectional study. Chuang L, editor. PLoS One [Internet]. 2019 Jun 19 [cited 2020 Feb 21];14(6):e0218559. Available from: https://doi.org/10.1371/journal.pone.0218559 source

      The Results and Discussion report that careHPV sensitivity tended to decrease with age, from about 95% in women aged 25–34 to about 82% in women aged 55–64. The Methods describe cervical samples collected during a gynecological examination; the paper does not report that combining careHPV with self-sampling reduced sensitivity, including among older women. Page numbers are unavailable in our copy. (LLM, conf=0.88)

      Experimental — accuracy not yet measured

  • May combine two claims.

    Premisecitation

    The Anyplex assay has reported sensitivities ranging from 92.5 to 98.3% and specificities from 81.7 to 94.1% for detecting CIN2+.

    “For example, the Anyplex assay has been reported with sensitivities ranging from 92.5 to 98.3% and specificities from 81.7 to 94.1% for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+) [16, 17, 18].”
    Quote in the paperNot a substantial claim2 of 3 sources checked
    • cites [16] Jung S, Lee B, Kap;, Lee N, Kim Y, Oh EJ. Clinical validation of Anyplex II HPV HR detection test for cervical cancer screening in Korea. meridian.allenpress.comS Jung, B Lee, KN Lee, Y Kim, EJ OhArchives of Pathology & Laboratory Medicine, 2016•meridian.allenpress.com [Internet]. 2016 [cited 2024 Oct 31];140:276–80. Available from: https://meridian.allenpress.com/aplm/article-abstract/140/3/276/65056 source
    • cites [17] Hesselink AT, Sahli R, Berkhof J, Snijders PJF, van der Salm ML, Agard D et al. Clinical validation of Anyplex™ II HPV HR Detection according to the guidelines for HPV test requirements for cervical cancer screening. J Clin Virol [Internet]. 2016 Mar 1 [cited 2024 Nov 11];76:36–9. Available from: https://pubmed.ncbi.nlm.nih.gov/26809131/ source

      The Results passage in the indexed copy (Abstract; page not provided) reports 98.3% sensitivity and 93.6% specificity for detecting CIN2+, both within the cited ranges. It does not report the 92.5% sensitivity or the 81.7% and 94.1% specificity endpoints, so this source alone does not establish the full ranges attributed to the three citations. (LLM, conf=0.88)

      Experimental — accuracy not yet measured
    • cites [18] Oštrbenk A, Xu L, Arbyn M, Poljak M. Clinical and analytical evaluation of the anyplex II HPV HR detection assay within the VALGENT-3 framework. J Clin Microbiol. 2018;56(11). source

      The Discussion (page unavailable) reports CIN2+ sensitivities of 92.5% and 98.3% from earlier Anyplex studies, and Results Table 1 reports 94.1% specificity in women aged ≥30. Neither passage supports the claimed 81.7% lower specificity bound; a search for 81.7% found no matching result in our copy. (LLM, conf=0.88)

      Experimental — accuracy not yet measured

  • May combine two claims.

    Findingown data

    The 5 additional M10 positives were grouped into G2 (60%), G5 (20%), and G6 (20%) with mean Ct value 20.66 (95% CI, p < 0.05, SD 11.72, 9-33), not close to the manufacturer-set negative cutoff Ct > 39.

    “These samples can be grouped into G2 (60%), G5 (20%) and G6 (20%) with the mean Ct value of 20.66 (95% CI, p < 0.05, Standard Deviation (SD) of 11.72, 9–33) is not close to the manufacturer-set negative cutoff value of Ct > 39.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    M10 and Anyplex had positive agreement of 90.3% and negative agreement of 93.7% for hrHPV detection.

    “M10 and Anyplex have positive and negative agreement of 90.3% and 93.7%, respectively, which suggests that the results from both assays are in almost perfect agreement with one another”
    Quote in the paperSubstantial claim

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

    Premisecitation

    Xpert HPV demonstrated agreement of 91.5% (κ = 0.844) against Anyplex28.

    “This performance is comparable to the Xpert HPV (Cepheid), another cartridge-based POCT, which demonstrated an agreement of 91.5% (κ = 0.844) against Anyplex28, a broader Seegene assay designed to detect additional low-risk HPV types [13].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [13] Nassereddine H, Charpentier C, Bucau M, Joly V, Bienvenu L, Davitian C et al. Interest of cytology combined with Xpert® HPV and Anyplex® II HPV28 Detection human papillomavirus (HPV) typing: differential profiles of anal and cervical HPV lesions in HIV-infected patients on antiretroviral therapy. HIV Med [Internet]. 2018 Nov 1 [cited 2024 Nov 19];19(10):698–707. Available from: https://onlinelibrary.wiley.com/doi/full/https://doi.org/10.1111/hiv.12661 source

  • May combine two claims.

    Interpretationown data

    No one assay can be regarded as superior or inferior as both have demonstrated their strengths and weaknesses.

    “No one assay can be regarded as superior or inferior as both have demonstrated their strength and weaknesses.”
    Quote in the paperNot a substantial claim

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

    Premisecitation

    The WHO's Cervical Cancer Elimination Initiative outlined a three-pronged strategy: vaccination, screening, and treatment.

    “The WHO’s Cervical Cancer Elimination Initiative outlined a three-pronged strategy to eliminate cervical cancer as a public health threat: vaccination, screening, and treatment [3, 24].”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [3] Cervical Cancer Elimination Initiative [Internet]. [cited 2024 Nov 8]. 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.

    • cites [24] World Health Organization. Global strategy to accelerate the elimination of cervical cancer as a public health problem. World Health Organization [Internet]. 2020 [cited 2024 Nov 19];1–56. Available from: https://www.who.int/publications/i/item/9789240014107

      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). May combine two claims.

    Premisecitation

    Cotesting offers no additional benefit over stand-alone hrHPV DNA testing, and may result in higher colposcopy referrals due to false positives.

    “While cotesting offers no additional benefit over stand-alone hrHPV DNA testing, it may result in higher colposcopy referrals due to false positives [23].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [23] Liang LA, Einzmann T, Franzen A, Schwarzer K, Schauberger G, Schriefer D et al. Cervical cancer screening: Comparison of conventional pap smear test, liquid-based cytology, and human papillomavirus testing as stand-alone or cotesting strategies. Cancer Epidemiology Biomarkers and Prevention [Internet]. 2021 Mar 1 [cited 2024 Nov 20];30(3):474–84. Available from: https://doi.org/10.1158/1055-9965.EPI-20-1003 source

  • Probably not a substantial claim: may not pass S4 (based).

    Interpretationnone given

    M10's rapid, field-deployable design makes it suitable for resource-limited settings.

    “M10’s rapid, field-deployable design makes it suitable for resource-limited settings”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: M10 provides a portable, sample-to-result solution in approximately one hour and enables field-based testing.

  • Probably not a substantial claim: may not pass S4 (based). May combine two claims.

    Interpretationreasoning

    M10 can address diagnostic gaps on-site, eliminating the need for repeating the two-stage process, and ensuring timely results and treatment.

    “M10 can address diagnostic gaps on-site, eliminating the need for repeating the two-stage process, and in return ensuring timely results and treatment.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: M10 provides a portable, sample-to-result solution in approximately one hour and enables field-based testing.
    • Rests on an assumption: M10 detects HPV16, HPV18, and other hrHPV genotypes grouped as G1-G6.

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

    Interpretationreasoning

    M10's clinical utility as a triaging tool in resource-limited areas remains significant.

    “While M10 demonstrated slightly lower positive agreement for hrHPV detection than Anyplex, its clinical utility as a triaging tool in resource-limited areas remains significant.”
    Quote in the paperNot a substantial claim

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

    Premisecitation

    Sarawak faces significant healthcare access challenges, with more than half its population living in rural or hard-to-reach areas.

    “Sarawak, Malaysia’s largest region, faces significant healthcare access challenges, with more than half its population living in rural or hard-to-reach areas.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [2] Tan CS, Hamzah ND, Ismail ZHF, Jerip AR, Kipli M. Self-sampling in Human Papillomavirus screening during and post-COVID-19 pandemic. Med J Malaysia [Internet]. 2021 [cited 2021 May 28];76(3):298–303. Available from: http://www.ncbi.nlm.nih.gov/pubmed/34031326

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing). May combine two claims.

    Interpretationreasoning

    M10 has the potential to expand coverage and save lives by providing accessible and timely screening options.

    “By providing accessible and timely screening options, M10 has the potential to expand coverage and save lives.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S4 (based). May combine two claims.

    Interpretationnone given

    Anyplex provides enhanced genotyping capability in laboratory environments, allowing informed vaccine strategy.

    “while Anyplex provides enhanced genotyping capability in laboratory environments, allowing informed vaccine strategy.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: Anyplex is a clinically validated assay that conforms to international standards for primary cervical cancer screening.

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

    Premisecitation

    The WHO strategy emphasises screening 70% of women for hrHPV by age 35 and again by 45 using validated HPV DNA tests.

    “The second prong emphasises screening 70% of women for hrHPV by the age of 35 and again by 45 using validated HPV DNA tests.”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [3] Cervical Cancer Elimination Initiative [Internet]. [cited 2024 Nov 8]. 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.

    • cites [24] World Health Organization. Global strategy to accelerate the elimination of cervical cancer as a public health problem. World Health Organization [Internet]. 2020 [cited 2024 Nov 19];1–56. Available from: https://www.who.int/publications/i/item/9789240014107

      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).

    Premisecitation

    The WHO strategy aims to vaccinate 90% of girls under 15 with HPV vaccines.

    “The first prong aims to vaccinate 90% of girls under 15 with HPV vaccines.”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [3] Cervical Cancer Elimination Initiative [Internet]. [cited 2024 Nov 8]. 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.

    • cites [24] World Health Organization. Global strategy to accelerate the elimination of cervical cancer as a public health problem. World Health Organization [Internet]. 2020 [cited 2024 Nov 19];1–56. Available from: https://www.who.int/publications/i/item/9789240014107

      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 conductown data

    The minimum sample size was estimated at 139 samples based on an expected agreement rate of 90%, a ±5% margin of error, and a 95% confidence level.

    “The minimum sample size was estimated using Open Epi Sample size calculator (https://www.openepi.com/) at 139 samples, based on an expected agreement rate of 90%, a ± 5% margin of error, and a 95% confidence level.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    The study focused solely on the concordance between two assays without correlating hrHPV detection with cytological or histopathological outcomes.

    “This study focused solely on the concordance between two assays without correlating hrHPV detection with cytological or histopathological outcomes.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

    Interpretationnone given

    The use of POCT may ensure that hrHPV-positive women receive appropriate care and treatment within the same day.

    “The use of POCT may ensure that hrHPV-positive women receive appropriate care and treatment within the same day.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    All tests were valid by the detection of the respective internal controls.

    “All tests were valid by the detection of the respective internal controls.”
    Quote in the paperSubstantial claim

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

    Study design and conductreasoning

    The study included 151 samples, exceeding the calculated minimum requirement.

    “To ensure robustness, the study included 151 samples, which exceeded the calculated requirement.”
    Quote in the paperNot a substantial claim

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

    Premisecitation

    The WHO strategy ensures that 90% of women diagnosed with precancer or cancer receive appropriate treatment.

    “The third prong ensures that 90% of women diagnosed with precancer or cancer receive appropriate treatment.”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [3] Cervical Cancer Elimination Initiative [Internet]. [cited 2024 Nov 8]. 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.

    • cites [24] World Health Organization. Global strategy to accelerate the elimination of cervical cancer as a public health problem. World Health Organization [Internet]. 2020 [cited 2024 Nov 19];1–56. Available from: https://www.who.int/publications/i/item/9789240014107

      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). May combine two claims.

    Study design and conductnone given

    Samples were anonymised and blinded to the operator.

    “These samples were anonymised and blinded to the operator.”
    Quote in the paperNot a substantial claim

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

    Study design and conductnone given

    Posthoc selection of positive and negative samples may introduce bias but allows a higher number of positive samples to be evaluated for the concordance study.

    “Our posthoc selection of positive and negative samples may introduce bias but allows a higher number of positive samples to be evaluated for the concordance study.”
    Quote in the paperNot a substantial claim
26 of 26

  • The paper relies on this without support.

    The careHPV system lacked genotyping capability and internal control, limiting its effectiveness in providing a comprehensive profile of hrHPV genotype distribution in Sarawak.

    “However, the careHPV system lacked genotyping capability and internal control, limiting its effectiveness in providing a comprehensive profile of hrHPV genotype distribution in Sarawak.”

  • The paper relies on this without support.

    Anyplex relies on laboratory-based batch processing, reducing its applicability for point-of-care testing.

    “Yet, while Anyplex improved diagnostic depth, it relies on laboratory-based batch processing, reducing its applicability for point-of-care testing—a critical feature for effective screen-and-treat strategies in remote areas.”

  • The paper relies on this without support.

    No comparative study has evaluated M10's utility in detecting hrHPV.

    “To our knowledge, no comparative study has evaluated M10’s utility in detecting hrHPV.”

  • The paper relies on this without support.

    M10 provides a portable, sample-to-result solution in approximately one hour and enables field-based testing.

    “In late 2024, the Standard M10 cartridge-based HPV test was adopted, providing a portable, sample-to-result solution in approximately one hour.”

  • The paper relies on this without support.

    M10 detects HPV16, HPV18, and other hrHPV genotypes grouped as G1-G6.

    “This system not only detects HPV16, HPV18, and other hrHPV genotypes (grouped as G1-G6) but also enables field-based testing”

  • The paper relies on this without support.

    Anyplex is a clinically validated assay that conforms to international standards for primary cervical cancer screening.

    “Anyplex is a clinically validated assay that conforms to international standards for primary cervical cancer screening”

  • The paper relies on this without support.

    Both assays are CE-IVD certified and compliant with Malaysia's Medical Device Act (MDA).

    “Both assays are CE-IVD certified, and compliant with Malaysia’s Medical Device Act (MDA).”

  • The paper relies on this without support.

    Cervical cancer is primarily caused by persistent high-risk human papillomavirus (hrHPV) infections.

    “Cervical cancer, primarily caused by persistent high-risk human papillomavirus (hrHPV) infections, is a significant health burden”

  • The paper relies on this without support.

    Effective prevention depends on effective vaccination and early hrHPV detection.

    “Effective prevention depends on effective vaccination and early hrHPV detection.”
9 of 9

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.

  • Genogrouping agreement is reported as 82.5% despite 53 of 57 matches

    Minor

    Table 3 has 53 matching classifications among 57 samples, giving 92.98% agreement, not 82.5%. The reported κ of 0.91 is also incompatible with observed agreement of 82.5%.

  • Reported Ct range excludes two stated results

    Minor

    The five M10-positive, Anyplex-negative samples are reported to have Ct values ranging from 9 to 33, but the next sentence says two of those samples had Ct values below 9.

2 of 2

Cites

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Related

Authors
Jerip, A. R., Noni, V., Anthony, V. K., Bong, A. C. S., Adam, J., & Tan, C. S.
Affiliations
Universiti Malaysia Sarawak (MY)
Corresponding author
Tan, Cheng Siang
ORCID
Venue
BMC Infectious Diseases
Publisher
Springer Science and Business Media LLC
Published
2025-03-03
Volume
25
Issue
1
Pages
304-304
ISSN
1471-2334 (ISSN-L)
DOI
10.1186/s12879-025-10714-y
PMC
PMC11877861
OpenAlex
W4408100943
Semantic Scholar
c8ded9c13279edb8b033dd70783b5cf09701f8dd
Cited by
1
References
17
Citations by year
2026: 1
FWCI
0.61
Type
journal article
Language
en
Open access
Licence
Locations
  • BMC Infectious Diseases (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Unimas Institutional Repository (Universiti Malaysia Sarawak) (acceptedVersion)
  • Europe PMC (PubMed Central) (submittedVersion, cc-by)
  • PubMed Central (submittedVersion, cc-by)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
Universiti Malaysia Sarawak
Topics
  • Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
  • Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Women's cancer prevention and management
Keywords
high-risk HPV, HPV genotyping, point-of-care testing, assay concordance, cervical cancer prevention, self-collected vaginal swabs, HPV16, HPV 18, resource-limited settings, Sarawak, cervical cancer screening
MeSH terms
Point-of-Care Testing, Human Papillomavirus Viruses, Adult, Uterine Cervical Neoplasms, Female, Genotype, Humans, Malaysia, Middle Aged, Sensitivity and Specificity, Vagina, Biosensing Techniques, Molecular Diagnostic Techniques, Papillomaviridae, Papillomavirus Infections, Young Adult

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-16.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-16.

Cited sources are checked by gpt-6-sol.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

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