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Intra- and interlaboratory reproducibility evaluation toward international validation status of the AmpFire assay.
Chung, Pui Yan Jenny; Dhillon, Sharonjit K; Baraquin, Alice; Tkachenka, Yuliya; Jacquot, Killian; Prétet, Jean-Luc; Broeck, Davy Vanden; Arbyn, Marc.
Afiliação
  • Chung PYJ; Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium.
  • Dhillon SK; Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium.
  • Baraquin A; CHU Besançon, Centre National de Référence Papillomavirus, Besançon, France.
  • Tkachenka Y; Department of Clinical Trials, Sonic Healthcare Benelux-AML, Antwerp, Belgium.
  • Jacquot K; CHU Besançon, Centre National de Référence Papillomavirus, Besançon, France.
  • Prétet JL; CHU Besançon, Centre National de Référence Papillomavirus, Besançon, France.
  • Broeck DV; Carcinogenèse associée aux HPV, Université de Franche-Comté, Besançon, France.
  • Arbyn M; Department of Primary Healthcare, Faculty of Medicine and Health Sciences, University Ghent, Ghent, Belgium.
J Med Virol ; 96(6): e29688, 2024 Jun.
Article em En | MEDLINE | ID: mdl-38847316
ABSTRACT
To meet the screening goal of WHO's 90-70-90 strategy aimed at eliminating cervical cancer (CC) by 2030, clinical validation of human papillomavirus (HPV) assays is essential to provide accurate and valid results through fulfilling three criteria of the international validation guidelines (IVGs). Previously, the clinical accuracy of the AmpFire® HPV Screening 16/18/HR assay (AmpFire assay) was reported but reproducibility data are lacking. Here, we aim to evaluate the intra- and inter-laboratory reproducibility of the AmpFire assay. The reproducibility of the isothermal AmpFire assay was assessed using 556 cervical cell samples collected from women attending CC screening and biobanked in a Belgian HPV national reference center. This assay detects HPV16, HPV18, and 12 other high-risk HPV (hrHPV) types (31/33/35/39/45/51/52/56/58/59/66/68) in aggregate. Lower 95% confidence interval bound around the assay's reproducibility should exceed 87%, with κ ≥ 0.50. Additionally, a literature review of the assay's clinical performance was performed. The AmpFire assay showed an excellent intralaboratory (96.4%, 95% CI94.5-97.8%, κ = 0.920) and interlaboratory (95.3%, 95% CI93.2-96.9%, κ = 0.897) reproducibility. One study demonstrated noninferior sensitivity of a prototype AmpFire assay targeting 15 hrHPV types (including HPV53) to detect CIN2+. However, clinical specificity became similar to the comparator after removing HPV53 from analyses. The low-cost and easy-to-use AmpFire assay presents excellent reproducibility and-after removing HPV53 from the targeted types-fulfills also clinical accuracy requirements. Inclusion of HPV53, which is not recognized as carcinogenic, comprises clinical specificity of screening assays.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias do Colo do Útero / Infecções por Papillomavirus Limite: Adult / Female / Humans / Middle aged País/Região como assunto: Europa Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias do Colo do Útero / Infecções por Papillomavirus Limite: Adult / Female / Humans / Middle aged País/Região como assunto: Europa Idioma: En Ano de publicação: 2024 Tipo de documento: Article