The Sansure® Human Papillomavirus DNA Diagnostic Kit offers excellent reproducibility performance for the detection of high-risk HPV.
Humans
Female
Papillomavirus Infections
/ diagnosis
Reproducibility of Results
Reagent Kits, Diagnostic
/ standards
DNA, Viral
/ genetics
Adult
Middle Aged
Papillomaviridae
/ genetics
Uterine Cervical Neoplasms
/ diagnosis
Early Detection of Cancer
/ methods
Belgium
Sensitivity and Specificity
Aged
Molecular Diagnostic Techniques
/ methods
Human Papillomavirus Viruses
HPV testing
Sansure
cervical cancer
reproducibility
screening
validation
Journal
Journal of medical virology
ISSN: 1096-9071
Titre abrégé: J Med Virol
Pays: United States
ID NLM: 7705876
Informations de publication
Date de publication:
Oct 2024
Oct 2024
Historique:
revised:
09
09
2024
received:
19
06
2024
accepted:
29
09
2024
medline:
18
10
2024
pubmed:
18
10
2024
entrez:
18
10
2024
Statut:
ppublish
Résumé
Cervical cancer screening is a cornerstone of cervical cancer elimination. Detection of high-risk human papillomavirus (hrHPV) is recommended as the first step in screening provided that the assay used has been adequately validated. The Sansure® Human Papillomavirus DNA Diagnostic Kit is a new assay designed to detect HPV16, HPV18 and 13 other HPV in aggregate. The study aimed to evaluate the intra- and interlaboratory reproducibility of the assay according to international guidelines. Five hundred and fifty cervical residual cell samples from women attending cervical cancer screening were selected from the biobank of the HPV National Reference Centre in Belgium and used in this study. After DNA extraction, HPV was tested using the Sansure® Human Papillomavirus DNA Diagnostic Kit. The lower 95% confidence limit around the general reproducibility of this assay should be greater than or equal to 87%, with κ ≥ 0.50. Five hundred and thirty-three samples had valid results. The Sansure® Human Papillomavirus DNA Diagnostic Kit demonstrated an excellent intra-laboratory reproducibility of 93.8% (95% confidence interval [CI]: 91.4-95.7, κ = 0.85). The interlaboratory reproducibility was 93.4 (95% CI: 91.0-95.4, κ = 0.84). Intra and interlaboratory reproducibility were also excellent at the genotype level. Excluding HPV53 single infection samples from the analyses also resulted in excellent agreement. These data show that the Sansure® Human Papillomavirus DNA Diagnostic Kit is highly reproducible.
Substances chimiques
Reagent Kits, Diagnostic
0
DNA, Viral
0
Types de publication
Journal Article
Evaluation Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
e29961Subventions
Organisme : Sansure
Organisme : Research and Innovation of the European Commission
ID : 847845
Informations de copyright
© 2024 The Author(s). Journal of Medical Virology published by Wiley Periodicals LLC.
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