Clinical validation of the fully automated NeuMoDx HPV assay for cervical cancer screening
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Authors
Heideman, Daniëlle A. M.
Valenčak, Anja Oštrbenk
Doorn, Saskia
Bonde, Jesper
Hillemanns, Peter
Domjanič, Grega Gimpelj
Mlakar, Jana
Hesselink, Albertus T.
Meijer, Chris J. L. M.
Poljak, Mario
Issue Date
2022-04-25
Type
Article
Language
en_US
Keywords
Human Papillomavirus , NeuMoDx HPV Test Strip , Clinical Performance , Reproducibility , Cervical Cancer Screening , Liquid Medium
Alternative Title
Abstract
The NeuMoDx HPV assay is a novel fully automated, real-time PCR-based assay for the qualitative detection of high-risk human papillomavirus (HPV) DNA in cervical specimens. The assay specifically identifies HPV16 and HPV18 and concurrently detects 13 other high-risk HPV types at clinically relevant infection levels. Following the international guidelines, the clinical performance of the NeuMoDx HPV assay for cervical intraepithelial neoplasia grade 2 or worse (CIN2+) against the reference standard Hybrid Capture 2, as well as intra- and inter-laboratory reproducibility were assessed on PreservCyt samples. The clinical accuracy of the assay was additionally evaluated against the clinically validated Alinity m HR HPV and COBAS 4800 HPV Test on PreservCyt samples, and against the clinically validated HPV-Risk assay on SurePath samples. The NeuMoDx HPV assay performance for CIN2+ was non-inferior to the reference methods on both sample types (all p < 0.05), and showed excellent intra- and inter-laboratory reproducibility (95.7%; 95% CI: 93.9–97.3; kappa value 0.90 (95% CI: 0.86–0.94); and 94.5%; 95% CI: 92.6–96.2; kappa value 0.87 (95% CI: 0.82–0.92), respectively). In conclusion, the NeuMoDx HPV assay meets international guideline criteria for cross-sectional accuracy and reproducibility, and performs equally well on cervical screening specimens collected in two widely used collection media. The NeuMoDx HPV assay fulfils the requirements to be used for primary cervical screening.
Description
Citation
Heideman, D. A. M., Oštrbenk Valenčak, A., Doorn, S., Bonde, J., Hillemanns, P., Gimpelj Domjanič, G., Mlakar, J., Hesselink, A. T., Meijer, C. J. L. M., & Poljak, M. (2022). Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening. Viruses, 14(5), 893. https://doi.org/10.3390/v14050893
Publisher
Viruses