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  1. Article ; Online: Risk adaptive triage in cervical screening: challenges and opportunities.

    Cuschieri, Kate

    Cytopathology : official journal of the British Society for Clinical Cytology

    2021  Volume 32, Issue 6, Page(s) 712–713

    Language English
    Publishing date 2021-07-16
    Publishing country England
    Document type Journal Article
    ZDB-ID 1034190-0
    ISSN 1365-2303 ; 0956-5507 ; 1350-4037
    ISSN (online) 1365-2303
    ISSN 0956-5507 ; 1350-4037
    DOI 10.1111/cyt.13026
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  2. Article ; Online: Challenges for cervical screening in people experiencing homelessness.

    Hawkins, Katie Eirian / Gourlay, Kyra / Cuschieri, Kate

    BMJ sexual & reproductive health

    2024  Volume 50, Issue 2, Page(s) 150–151

    MeSH term(s) Humans ; Female ; Early Detection of Cancer ; Uterine Cervical Neoplasms/diagnosis ; Ill-Housed Persons
    Language English
    Publishing date 2024-04-11
    Publishing country England
    Document type Letter
    ISSN 2515-2009
    ISSN (online) 2515-2009
    DOI 10.1136/bmjsrh-2023-202023
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  3. Article ; Online: Predictable changes in the accuracy of human papillomavirus tests after vaccination: review with implications for performance monitoring in cervical screening.

    Rebolj, Matejka / Brentnall, Adam R / Cuschieri, Kate

    British journal of cancer

    2024  

    Abstract: Vaccination against human papillomavirus (HPV) is changing the performance of cytology as a cervical screening test, but its effect on HPV testing is unclear. We review the effect of HPV16/18 vaccination on the epidemiology and the detection of HPV ... ...

    Abstract Vaccination against human papillomavirus (HPV) is changing the performance of cytology as a cervical screening test, but its effect on HPV testing is unclear. We review the effect of HPV16/18 vaccination on the epidemiology and the detection of HPV infections and high-grade cervical lesions (CIN2+) to evaluate the likely direction of changes in HPV test accuracy. The reduction in HPV16/18 infections and cross-protection against certain non-16/18 high-risk genotypes, most notably 31, 33, and/or 45, will likely increase the test's specificity but decrease its positive predictive value (PPV) for CIN2+. Post-vaccination viral unmasking of non-16/18 genotypes due to fewer HPV16 co-infections might reduce the specificity and the PPV for CIN2+. Post-vaccination clinical unmasking exposing a higher frequency of CIN2+ related to non-16/18 high-risk genotypes is likely to increase the specificity and the PPV of HPV tests. The effect of HPV16/18 vaccination on HPV test sensitivity is difficult to predict based on these changes alone. Programmes relying on HPV detection for primary screening should monitor the frequency of false-positive and false-negative tests in vaccinated (younger) vs. unvaccinated (older) cohorts, to assess the outcomes and performance of their service.
    Language English
    Publishing date 2024-04-13
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 80075-2
    ISSN 1532-1827 ; 0007-0920
    ISSN (online) 1532-1827
    ISSN 0007-0920
    DOI 10.1038/s41416-024-02681-z
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  4. Article ; Online: Testing for Human Papillomaviruses in Urine, Blood, and Oral Specimens: an Update for the Laboratory.

    Poljak, Mario / Cuschieri, Kate / Alemany, Laia / Vorsters, Alex

    Journal of clinical microbiology

    2023  Volume 61, Issue 8, Page(s) e0140322

    Abstract: Twelve high-risk alpha human papillomavirus (HPV) genotypes cause approximately 690,000 cancer cases annually, with cervical and oropharyngeal cancer being the two most prominent types. HPV testing is performed in laboratory settings for various ... ...

    Abstract Twelve high-risk alpha human papillomavirus (HPV) genotypes cause approximately 690,000 cancer cases annually, with cervical and oropharyngeal cancer being the two most prominent types. HPV testing is performed in laboratory settings for various applications of a clinical, epidemiological, and research nature using a range of clinical specimens collected by clinicians or by individuals (self-collected specimens). Here, we reflect on the importance and justification of using the right test for the right application and provide practical updates for laboratories either participating in or anticipating involvement in HPV testing in three specimen types, namely, urine, blood, and oral specimens, which are considered "alternative" specimens by many. In addition to clinician-collected cervical samples and self-collected cervicovaginal samples, first-void urine is emerging as a credible specimen for HPV-based cervical cancer screening, triage of HPV screen-positive women, monitoring HPV vaccine impact, and HPV testing in groups for which a less invasive sample is preferred. Detection of cell-free DNA (including HPV DNA) in blood has great promise for the early detection of HPV-attributable oropharyngeal cancer (HPV-AOC) and potentially other HPV-driven cancers and as an adjunct prognostic marker in long-term tumor surveillance, including treatment response. The moderate sensitivity of HPV testing in oral rinses or swabs at HPV-AOC diagnosis prevents its use in HPV-AOC secondary prevention but represents a promising prognostic tool in HPV-AOC tertiary prevention, where the HPV persistence in oral rinses throughout treatment may predict early HPV-AOC recurrences and/or the development of secondary HPV-AOC. The increasing sophistication of specific collection devices designed for alternative samples and the enhanced precision of novel molecular technologies are likely to support the evolution of this field and catalyze potential translation into routine practice.
    MeSH term(s) Humans ; Female ; Uterine Cervical Neoplasms/diagnosis ; Human Papillomavirus Viruses ; Uterine Cervical Dysplasia/diagnosis ; Papillomavirus Infections/diagnosis ; Early Detection of Cancer ; Laboratories ; Papillomaviridae/genetics ; Oropharyngeal Neoplasms ; DNA, Viral/genetics ; DNA, Viral/urine ; Sensitivity and Specificity ; Vaginal Smears
    Chemical Substances DNA, Viral
    Language English
    Publishing date 2023-07-13
    Publishing country United States
    Document type Journal Article ; Review ; Research Support, Non-U.S. Gov't
    ZDB-ID 390499-4
    ISSN 1098-660X ; 0095-1137
    ISSN (online) 1098-660X
    ISSN 0095-1137
    DOI 10.1128/jcm.01403-22
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  5. Article ; Online: Can REALQUALITY RQ-HPV screen be considered as a clinically validated HPV test for use in cervical cancer screening?

    Arbyn, Marc / Cuschieri, Kate / Poljak, Mario / Bonde, Jesper

    Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases

    2023  Volume 29, Issue 12, Page(s) 1608–1609

    MeSH term(s) Female ; Humans ; Uterine Cervical Neoplasms ; Early Detection of Cancer ; Papillomavirus Infections/diagnosis ; Uterine Cervical Dysplasia/diagnosis ; Vaginal Smears ; Mass Screening ; Papillomaviridae/genetics
    Language English
    Publishing date 2023-08-25
    Publishing country England
    Document type Letter ; Comment
    ZDB-ID 1328418-6
    ISSN 1469-0691 ; 1470-9465 ; 1198-743X
    ISSN (online) 1469-0691
    ISSN 1470-9465 ; 1198-743X
    DOI 10.1016/j.cmi.2023.08.020
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    Zs.MO 284: Show issues

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  6. Article ; Online: Allplex HPV HR Detection assay fulfils all clinical performance and reproducibility validation requirements for primary cervical cancer screening.

    Oštrbenk Valenčak, Anja / Cuschieri, Kate / Connor, Linzi / Zore, Andrej / Smrkolj, Špela / Poljak, Mario

    Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology

    2024  Volume 170, Page(s) 105638

    Abstract: Human papillomavirus (HPV)-based screening offers better protection against cervical cancer compared to cytology, but HPV screening assays must adhere to validation requirements of the international guidelines to ensure optimal performance. Allplex HPV ... ...

    Abstract Human papillomavirus (HPV)-based screening offers better protection against cervical cancer compared to cytology, but HPV screening assays must adhere to validation requirements of the international guidelines to ensure optimal performance. Allplex HPV HR Detection (Allplex) assay, launched in the late 2022, is a fully automated real-time PCR-based assay utilizing innovative technology that enables quantification and concurrent distinction of 14 high-risk HPV genotypes (HPV16,18,31,33,35,39,45,51,52,56,58,59,66 and 68). We assessed the validity of the Allplex for cervical cancer screening purposes, via comparison to a clinically validated comparator assay (Hybrid Capture 2; HC2), and through assessment of intra-laboratory reproducibility and inter-laboratory agreement. A clinical validation panel comprised of 973 residual ThinPrep samples was obtained from women aged 30-64 years participating in the organized Slovenian screening program, of these 863 were from women undergoing their regular screening visit after a previous negative screen test while 110 were from women with underlying cervical intraepithelial neoplasia grade 2 or worse (CIN2+) lesions. The Allplex's relative clinical sensitivity for detection of CIN2+ and CIN3+ were 1.01 (95%CI;0.98-1.04) and 0.98 (95%CI;0.95-1.02), compared to that of HC2. At recommended thresholds of ≥98% and ≥90%, the Allplex's clinical sensitivity and specificity (p=0.0004 and p=0.02, respectively) were non-inferior to HC2. High intra-laboratory reproducibility and inter-laboratory agreement, both overall (98.1% and 97.9%, respectively) and at genotype level (>98.7%) was observed. In addition, analytical genotype-specific performance of Allplex was compared to that of its predecessor Anyplex HPV HR; high overall agreement was observed (96.3%; kappa value 0.88), with some variations in performance. In conclusion, Allplex met all validation criteria described in the international guidelines on sensitivity, specificity and laboratory reproducibility and can be considered clinically validated for primary cervical cancer screening.
    MeSH term(s) Female ; Humans ; Uterine Cervical Neoplasms ; Early Detection of Cancer ; Papillomavirus Infections/diagnosis ; Reproducibility of Results ; Papillomaviridae/genetics ; Uterine Cervical Dysplasia/diagnosis ; Genotype ; Sensitivity and Specificity
    Language English
    Publishing date 2024-01-01
    Publishing country Netherlands
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1446080-4
    ISSN 1873-5967 ; 1386-6532
    ISSN (online) 1873-5967
    ISSN 1386-6532
    DOI 10.1016/j.jcv.2023.105638
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    Zs.A 3790: Show issues Location:
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  7. Article ; Online: 2023 global inventory of commercial molecular tests for human papillomaviruses (HPV).

    Poljak, Mario / Oštrbenk Valenčak, Anja / Cuschieri, Kate / Bohinc, Klara B / Arbyn, Marc

    Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology

    2024  Volume 172, Page(s) 105671

    Abstract: To suit the needs of the human papillomaviruses (HPV) community comprehensively, a range of commercial HPV tests with different performance characteristics are required. Four periodic inventories of commercial HPV molecular tests present in the global ... ...

    Abstract To suit the needs of the human papillomaviruses (HPV) community comprehensively, a range of commercial HPV tests with different performance characteristics are required. Four periodic inventories of commercial HPV molecular tests present in the global market were published previously in 2010, 2012, 2015 and 2020. For the fifth inventory, data were retrieved from internal files and a detailed search using the main bibliographic databases as well as general internet search without period or language restrictions was performed in December 2023. At least 264 distinct HPV tests (and 511 test variants) were available globally in December 2023. A small 2020-2023 net increase in total numbers was observed, but with a strong introduction/withdrawal dynamic: 86 new distinct HPV tests (and 141 variants) were introduced and 76 tests (and 55 variants) were withdrawn from the market in the last four years. Although quality improvement of some tests was recorded, half of all HPV tests are still without a single peer-reviewed publication, and 79 % of tests are without published evidence that demonstrate performance characteristics are in line with requirements agreed in the HPV community. Only a relatively small pool of tests fulfill the operational/performance characteristics required to meet the global cervical cancer screening challenge. Although clinical and analytical performance characteristics of many commercial HPV tests are largely unknown, such tests are used worldwide in daily clinical practice and research, with potentially deleterious consequences. Due to this long-lasting unfavorable situation, significant scope for improvement persists for both manufacturers of HPV tests and the HPV community.
    Language English
    Publishing date 2024-03-14
    Publishing country Netherlands
    Document type Journal Article ; Review
    ZDB-ID 1446080-4
    ISSN 1873-5967 ; 1386-6532
    ISSN (online) 1873-5967
    ISSN 1386-6532
    DOI 10.1016/j.jcv.2024.105671
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    Zs.A 3790: Show issues Location:
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  8. Article ; Online: The changing nature of HPV associated with high grade cervical lesions in vaccinated populations, a retrospective study of over 1700 cases in Scotland.

    Cuschieri, Kate / Palmer, Tim / Graham, Catriona / Cameron, Ross / Roy, Kirsty

    British journal of cancer

    2023  Volume 129, Issue 7, Page(s) 1134–1141

    Abstract: Background: Understanding the pattern and dominance of HPV types in high grade cervical disease within increasingly vaccinated populations will help inform the development of appropriate screening and management protocols.: Methods: Over 1700 cases ... ...

    Abstract Background: Understanding the pattern and dominance of HPV types in high grade cervical disease within increasingly vaccinated populations will help inform the development of appropriate screening and management protocols.
    Methods: Over 1700 cases of cervical intraepithelial neoplasia (CIN) diagnosed between 2011 and 2017 in women younger than 25 were genotyped for HPV. Logistic regression was used to assess the association between HPV 16/18 positivity with biopsy-collection year, birth year, deprivation and vaccination status. Regression analysis was repeated for cross-protective types (31, 33 and 45). Type specific detail of non-vaccine types by vaccination status was presented descriptively.
    Results: Detection of HPV 16/18 or 16/18/31/33 and 45 was lower in CIN2 associated with full vaccination vs no vaccination (OR 0.3; 95% CI 0.2-0.5 & 0.4; 95% CI 0.3-0.6 respectively) Similar observations were made for CIN3. The relative contribution of non-established high-risk types including those considered low risk was greater among vaccinated women with CIN2+ vs unvaccinated women with CIN2+.
    Conclusions: The change in HPV distribution in CIN2+ in vaccinated populations is a further marker of vaccine impact. Additionally, the progression rate of CIN2+ in vaccinated populations may be lower given the shift in type distribution. The definition of high grade disease in vaccinated populations may warrant reassessment.
    MeSH term(s) Female ; Humans ; Uterine Cervical Neoplasms/epidemiology ; Uterine Cervical Neoplasms/prevention & control ; Uterine Cervical Neoplasms/diagnosis ; Retrospective Studies ; Papillomavirus Infections/complications ; Papillomavirus Infections/epidemiology ; Papillomavirus Infections/prevention & control ; Human papillomavirus 16/genetics ; Papillomavirus Vaccines/therapeutic use ; Human papillomavirus 18/genetics ; Uterine Cervical Dysplasia ; Scotland/epidemiology ; Papillomaviridae/genetics
    Chemical Substances Papillomavirus Vaccines
    Language English
    Publishing date 2023-08-10
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 80075-2
    ISSN 1532-1827 ; 0007-0920
    ISSN (online) 1532-1827
    ISSN 0007-0920
    DOI 10.1038/s41416-023-02386-9
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  9. Article ; Online: Human Papillomavirus Immunization and the Elimination of Cervical Carcinoma.

    Palmer, Timothy / Cuschieri, Kate

    Annals of internal medicine

    2020  Volume 173, Issue 11, Page(s) 935–936

    MeSH term(s) Alphapapillomavirus ; Bhutan ; Carcinoma ; Cross-Sectional Studies ; Female ; Humans ; Immunization ; Papillomavirus Infections/prevention & control ; Papillomavirus Vaccines ; Prevalence ; Uterine Cervical Neoplasms/prevention & control
    Chemical Substances Papillomavirus Vaccines
    Language English
    Publishing date 2020-09-22
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 336-0
    ISSN 1539-3704 ; 0003-4819
    ISSN (online) 1539-3704
    ISSN 0003-4819
    DOI 10.7326/M20-6011
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  10. Article ; Online: Widening the offer of human papillomavirus self-sampling to all women eligible for cervical screening: Make haste slowly.

    Rebolj, Matejka / Sargent, Alexandra / Njor, Sisse Helle / Cuschieri, Kate

    International journal of cancer

    2022  Volume 153, Issue 1, Page(s) 8–19

    Abstract: Self-collection of samples for human papillomavirus (HPV) testing has the potential to increase the uptake of cervical screening among underscreened women and will likely form a crucial part of the WHO's strategy to eliminate cervical cancer by 2030. In ... ...

    Abstract Self-collection of samples for human papillomavirus (HPV) testing has the potential to increase the uptake of cervical screening among underscreened women and will likely form a crucial part of the WHO's strategy to eliminate cervical cancer by 2030. In high-income countries with long-standing, organised cervical screening programmes, self-collection is increasingly becoming available as a routine offer for women regardless of their screening histories, including under- and well-screened women. For these contexts, a validated microsimulation model determined that adding self-collection to clinician collection is likely to be cost-effective on the condition that it meets specific thresholds relating to (1) uptake and (2) sensitivity for the detection of high-grade cervical intraepithelial neoplasia (CIN2+). We used these thresholds to review the 'early-adopter' programme-level evidence with a mind to determine how well and how consistently they were being met. The available evidence suggested some risk to overall programme performance in the situation where low uptake among underscreened women was accompanied by a high rate of substituting clinician sampling with self-collection among well-screened women. Risk was further compounded in a situation where the slightly reduced sensitivity of self-sampling vs clinician sampling for the detection of CIN2+ was accompanied with lack of adherence to a follow-up triage test that required a clinician sample. To support real-world programmes on their pathways toward implementation and to avoid HPV self-collection being introduced as a screening measure in good faith but with counterproductive consequences, we conclude by identifying a range of mitigations and areas worthy of research prioritisation.
    MeSH term(s) Female ; Humans ; Uterine Cervical Neoplasms ; Human Papillomavirus Viruses ; Papillomavirus Infections ; Early Detection of Cancer ; Cervix Uteri ; Uterine Cervical Dysplasia ; Mass Screening ; Vaginal Smears ; Papillomaviridae
    Language English
    Publishing date 2022-11-23
    Publishing country United States
    Document type Journal Article ; Review ; Research Support, Non-U.S. Gov't
    ZDB-ID 218257-9
    ISSN 1097-0215 ; 0020-7136
    ISSN (online) 1097-0215
    ISSN 0020-7136
    DOI 10.1002/ijc.34358
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    Zs.MO 576: Show issues

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