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Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening

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Abstract
Background Cervical cancer screening with assays detecting DNA of high-risk human papillomavirus (hrHPV) types is more effective than cytology-based screening. This study completes the diagnostic accuracy assessment conducted previously within the framework of VALGENT-2 (Validation of HPV genotyping Tests) and aims to determine whether the reproducibility of Xpert HPV is in line with international validation criteria.MethodsValidation of new hrHPV DNA assays requires demonstration of good reproducibility and non-inferior clinical accuracy for cervical precancer compared to a standard comparator assay. The international reproducibility criteria are: lower bound of 95% confidence interval of the intra- and inter-laboratory agreement regarding detection of high-risk HPV DNA exceeding 87% with kappa 0.5.ResultsThe Xpert HPV assay showed high intra-laboratory reproducibility with an overall positivity/negativity agreement of 96.9% and a kappa of 0.925. Inter-laboratory testing showed an agreement of 97.8% with a kappa of 0.948.ConclusionsThe Xpert HPV assay fulfills the HPV test reproducibility criterion requirement for use in cervical cancer screening.
Keywords
CLINICAL VALIDATION, PCR, PERFORMANCE, VALGENT, TESTS, Human papillomavirus, Real-time sequencing, Cervical cancer screening

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Chicago
Akbari, Ajmal, Davy Vanden Broeck, Ina Benoy, Elizaveta Padalko, Johannes Bogers, and Marc Arbyn. 2018. “Validation of Intra- and Inter-laboratory Reproducibility of the Xpert HPV Assay According to the International Guidelines for Cervical Cancer Screening.” Virology Journal 15.
APA
Akbari, A., Vanden Broeck, D., Benoy, I., Padalko, E., Bogers, J., & Arbyn, M. (2018). Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening. VIROLOGY JOURNAL, 15.
Vancouver
1.
Akbari A, Vanden Broeck D, Benoy I, Padalko E, Bogers J, Arbyn M. Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening. VIROLOGY JOURNAL. 2018;15.
MLA
Akbari, Ajmal et al. “Validation of Intra- and Inter-laboratory Reproducibility of the Xpert HPV Assay According to the International Guidelines for Cervical Cancer Screening.” VIROLOGY JOURNAL 15 (2018): n. pag. Print.
@article{8615403,
  abstract     = {Background Cervical cancer screening with assays detecting DNA of high-risk human papillomavirus (hrHPV) types is more effective than cytology-based screening. This study completes the diagnostic accuracy assessment conducted previously within the framework of VALGENT-2 (Validation of HPV genotyping Tests) and aims to determine whether the reproducibility of Xpert HPV is in line with international validation criteria.MethodsValidation of new hrHPV DNA assays requires demonstration of good reproducibility and non-inferior clinical accuracy for cervical precancer compared to a standard comparator assay. The international reproducibility criteria are: lower bound of 95% confidence interval of the intra- and inter-laboratory agreement regarding detection of high-risk HPV DNA exceeding 87% with kappa 0.5.ResultsThe Xpert HPV assay showed high intra-laboratory reproducibility with an overall positivity/negativity agreement of 96.9% and a kappa of 0.925. Inter-laboratory testing showed an agreement of 97.8% with a kappa of 0.948.ConclusionsThe Xpert HPV assay fulfills the HPV test reproducibility criterion requirement for use in cervical cancer screening.},
  articleno    = {166},
  author       = {Akbari, Ajmal and Vanden Broeck, Davy and Benoy, Ina and Padalko, Elizaveta and Bogers, Johannes and Arbyn, Marc},
  issn         = {1743-422X},
  journal      = {VIROLOGY JOURNAL},
  keywords     = {CLINICAL VALIDATION,PCR,PERFORMANCE,VALGENT,TESTS,Human papillomavirus,Real-time sequencing,Cervical cancer screening},
  language     = {eng},
  pages        = {5},
  title        = {Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening},
  url          = {http://dx.doi.org/10.1186/s12985-018-1076-6},
  volume       = {15},
  year         = {2018},
}

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