TY - JOUR
T1 - Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening
AU - Heideman, Daniëlle A. M.
AU - Valenčak, Anja O. trbenk
AU - Doorn, Saskia
AU - Bonde, Jesper
AU - Hillemanns, Peter
AU - Domjanič, Grega Gimpelj
AU - Mlakar, Jana
AU - Hesselink, Albertus T.
AU - Meijer, Chris J. L. M.
AU - Poljak, Mario
N1 - Funding Information: Funding: This research was funded by QIAGEN GmbH, 40724 Hilden, Germany (funding number 264022-21). QIAGEN was not involved in the study design, data collection and analysis, interpretation of the results, or writing of the manuscript. Funding Information: Acknowledgments: A.O.V.’s: M.P.’s, G.G.D.’s and J.M.’s institution has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under grant agreement No. 847845 (Project RISCC). We want to thank E.C. and S.B. for technical support from NeuMoDx molecular, a QIAGEN company, and V.A. for excellent technical assistance. The test kits and access to N96 instruments were kindly supported by NeuMoDx molecular, a QIAGEN company. Publisher Copyright: © 2022 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2022/5/1
Y1 - 2022/5/1
N2 - 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.
AB - 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.
KW - NeuMoDx HPV Test Strip
KW - cervical cancer screening
KW - clinical performance
KW - human papillomavirus
KW - liquid medium
KW - reproducibility
UR - http://www.scopus.com/inward/record.url?scp=85129849687&partnerID=8YFLogxK
U2 - https://doi.org/10.3390/v14050893
DO - https://doi.org/10.3390/v14050893
M3 - Article
C2 - 35632634
SN - 1999-4915
VL - 14
JO - Viruses
JF - Viruses
IS - 5
M1 - 893
ER -