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Evaluation of the clinical performance of OncoPredict HPV® SCR assay within the VALGENT-2 framework.

Kwaliteit van de gezondheidszorg  
Ziekten en gezondheid in kaart brengen  
[1]
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Public Access

Published

Peer reviewed scientific article

Engels

DOI : https://doi.org/10.1002/jmv.28417 [2]

Auteurs

Sharon Dhillon [3]; Clementina E Cocuzza [4]; Pui Yan Jen Chung [5]; Marianna Martinelli [6]; Chiara Giubbi [7]; Ruth C Njoku [8]; Bhatia, Ramya [9]; Cuschieri, Kate [10]; M. Arbyn [11]

Trefwoorden

  1. Early Detection of Cancer [12]
  2. Female [13]
  3. Genotyping Techniques [14]
  4. Human Papillomavirus Viruses [15]
  5. Humans [16]
  6. Papillomaviridae [17]
  7. Papillomavirus Infections [18]
  8. Real-Time Polymerase Chain Reaction [19]
  9. Reproducibility of Results [20]
  10. Sensitivity and Specificity [21]
  11. Uterine Cervical Dysplasia [22]
  12. Uterine Cervical Neoplasms [23]
Article written during project(s) : 

Samenvatting:

Human papillomavirus (HPV) assays used in cervical cancer screening should be clinically validated according to international criteria. OncoPredict HPV® Screening (SCR) is a partial genotyping multiplex real-time PCR assay targeting E6/E7 genes of 13 high-risk (hr) HPVs. OncoPredict HPV® SCR (index assay) identifies HPV-16 and HPV-18 separately, 11 other hrHPV in aggregate and includes quality controls for sample adequacy, DNA extraction efficiency and PCR inhibition. 1300 VALGENT-2 study samples (from women aged 20-60 attending the Scottish cervical cancer screening program) were tested wi…
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Samenvatting

Human papillomavirus (HPV) assays used in cervical cancer screening should be clinically validated according to international criteria. OncoPredict HPV® Screening (SCR) is a partial genotyping multiplex real-time PCR assay targeting E6/E7 genes of 13 high-risk (hr) HPVs. OncoPredict HPV® SCR (index assay) identifies HPV-16 and HPV-18 separately, 11 other hrHPV in aggregate and includes quality controls for sample adequacy, DNA extraction efficiency and PCR inhibition. 1300 VALGENT-2 study samples (from women aged 20-60 attending the Scottish cervical cancer screening program) were tested with the index assay and the GP5+/6+ PCR enzyme immunoassay (standard comparator assay). Non-inferior accuracy detecting cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) of the index versus comparator was verified. Intra- and interlaboratory reproducibility of the index was evaluated by overall concordance and Cohen's kappa, using a sub-population (n = 526). Relative sensitivity and specificity for CIN2+ of the index versus comparator were 1.01 (95% confidence interval [CI]: 0.99-1.03) and 1.02 (95% CI: 1.0-1.04), respectively. Noninferiority p values were all ≤0.05, except for CIN3+ in patients ≥30 years. Excellent intra- and interlaboratory reproducibility was shown with concordance >98% and kappas >0.95. OncoPredict HPV® SCR fulfills the three international validation criteria for hrHPV DNA tests in cervical cancer screening.

Associated health topics:

Kwaliteit van de gezondheidszorg [24]
Kanker [25]

Source URL:https://sciensano.be/nl/biblio/evaluation-clinical-performance-oncopredict-hpvr-scr-assay-within-valgent-2-framework-0

Links
[1] https://sciensano.be/sites/default/files/doc74_evaluation_of_the_clinical_performance_of_oncopredict_hpvr.pdf [2] https://doi.org/10.1002/jmv.28417 [3] https://sciensano.be/nl/people/sharon-dhillon/biblio [4] https://sciensano.be/nl/biblio?f%5Bauthor%5D=186317&f%5Bsearch%5D=Clementina%20E%20Cocuzza [5] https://sciensano.be/nl/biblio?f%5Bauthor%5D=185436&f%5Bsearch%5D=Pui%20Yan%20Jen%20Chung [6] https://sciensano.be/nl/biblio?f%5Bauthor%5D=186313&f%5Bsearch%5D=Marianna%20Martinelli [7] https://sciensano.be/nl/biblio?f%5Bauthor%5D=186314&f%5Bsearch%5D=Chiara%20Giubbi [8] https://sciensano.be/nl/biblio?f%5Bauthor%5D=186318&f%5Bsearch%5D=Ruth%20C%20Njoku [9] https://sciensano.be/nl/biblio?f%5Bauthor%5D=53094&f%5Bsearch%5D=Bhatia%2C%20Ramya [10] https://sciensano.be/nl/biblio?f%5Bauthor%5D=52293&f%5Bsearch%5D=Cuschieri%2C%20Kate [11] https://sciensano.be/nl/people/marc-arbyn/biblio [12] https://sciensano.be/nl/biblio?f%5Bkeyword%5D=33630&f%5Bsearch%5D=Early%20Detection%20of%20Cancer [13] https://sciensano.be/nl/biblio?f%5Bkeyword%5D=2685&f%5Bsearch%5D=Female [14] https://sciensano.be/nl/biblio?f%5Bkeyword%5D=17814&f%5Bsearch%5D=Genotyping%20Techniques [15] https://sciensano.be/nl/biblio?f%5Bkeyword%5D=38138&f%5Bsearch%5D=Human%20Papillomavirus%20Viruses [16] https://sciensano.be/nl/biblio?f%5Bkeyword%5D=648&f%5Bsearch%5D=Humans [17] https://sciensano.be/nl/biblio?f%5Bkeyword%5D=33579&f%5Bsearch%5D=Papillomaviridae [18] https://sciensano.be/nl/biblio?f%5Bkeyword%5D=33132&f%5Bsearch%5D=Papillomavirus%20Infections [19] https://sciensano.be/nl/biblio?f%5Bkeyword%5D=3879&f%5Bsearch%5D=Real-Time%20Polymerase%20Chain%20Reaction [20] https://sciensano.be/nl/biblio?f%5Bkeyword%5D=2397&f%5Bsearch%5D=Reproducibility%20of%20Results [21] https://sciensano.be/nl/biblio?f%5Bkeyword%5D=2547&f%5Bsearch%5D=Sensitivity%20and%20Specificity [22] https://sciensano.be/nl/biblio?f%5Bkeyword%5D=33633&f%5Bsearch%5D=Uterine%20Cervical%20Dysplasia [23] https://sciensano.be/nl/biblio?f%5Bkeyword%5D=32811&f%5Bsearch%5D=Uterine%20Cervical%20Neoplasms [24] https://sciensano.be/nl/gezondheidsonderwerpen/kwaliteit-van-de-gezondheidszorg [25] https://sciensano.be/nl/gezondheidsonderwerpen/kanker