Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

Clinical performance of the full genotyping Agena MassARRAY HPV assay using SurePath screening samples within the VALGENT4 framework

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Multicenter Evaluation of the Idylla NRAS-BRAF Mutation Test in Metastatic Colorectal Cancer

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Diagnostic potential of miR-126, miR-143, miR-145, and miR-652 in malignant pleural mesothelioma

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. VALCOR: a protocol for the validation of SARS-corona virus-2 assays

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Differentieret implementering af HPV-baseret screening i dansk livmoderhalskræftscreening

    Publikation: Bidrag til tidsskriftReviewForskningpeer review

Vis graf over relationer

The clinical performance evaluation of the novel MassARRAY human papillomavirus (MA-HPV) assay was performed using Danish SurePath cervical cancer screening samples under the fourth Validation of HPV Genotyping Tests (VALGENT) framework. The MA-HPV assay is a mass array-based assay that individually detects 14 oncogenic HPV genotypes and five nononcogenic types. The MA-HPV assay was validated using the VALGENT4 panel, which constitutes 997 consecutive samples from a screening population in addition to 297 disease-enriched samples with abnormal cytology findings. The clinical accuracy of the MA-HPV assay for sensitivity and specificity was assessed relative to that of the general primer 5+/6+ PCR enzyme immunoassay (GP-EIA), by a noninferiority test. The type-specific concordance of the MA-HPV assay was assessed as well. The relative sensitivity of the MA-HPV assay for cervical intraepithelial neoplasia ≥2 or ≥3 was 1.02 (95% CI, 0.98-1.05) and 1.01 (95% CI, 0.99-1.04), respectively. The sensitivity of the MA-HPV was noninferior to that of the GP-EIA (P = 0.0001), whereas the specificity of the MA-HPV was inferior (0.89; 95% CI, 0.85-0.91; P > 0.99). The MA-HPV assay is a clinical sensitive assay with a lower clinical specificity compared with the GP-EIA. The assay in its current form seems more suited to play a role where specificity is of lesser importance but where high sensitivity is paramount.

OriginalsprogEngelsk
TidsskriftThe Journal of molecular diagnostics : JMD
Vol/bind24
Udgave nummer4
Sider (fra-til)365-373
Antal sider9
ISSN1525-1578
DOI
StatusUdgivet - 1 apr. 2022

Bibliografisk note

Copyright © 2022. Published by Elsevier Inc.

ID: 74072712