Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening
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...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-04-01
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| Series: | Viruses |
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| Online Access: | https://www.mdpi.com/1999-4915/14/5/893 |
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| author | Daniëlle A. M. Heideman Anja Oštrbenk Valenčak Saskia Doorn Jesper Bonde Peter Hillemanns Grega Gimpelj Domjanič Jana Mlakar Albertus T. Hesselink Chris J. L. M. Meijer Mario Poljak |
| author_facet | Daniëlle A. M. Heideman Anja Oštrbenk Valenčak Saskia Doorn Jesper Bonde Peter Hillemanns Grega Gimpelj Domjanič Jana Mlakar Albertus T. Hesselink Chris J. L. M. Meijer Mario Poljak |
| author_sort | Daniëlle A. M. Heideman |
| collection | DOAJ |
| description | 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 <i>p</i> < 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. |
| first_indexed | 2024-03-10T01:37:51Z |
| format | Article |
| id | doaj.art-d95a7c88fa8e4fd690ef7b240bcdf492 |
| institution | Directory Open Access Journal |
| issn | 1999-4915 |
| language | English |
| last_indexed | 2024-03-10T01:37:51Z |
| publishDate | 2022-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Viruses |
| spelling | doaj.art-d95a7c88fa8e4fd690ef7b240bcdf4922023-11-23T13:29:48ZengMDPI AGViruses1999-49152022-04-0114589310.3390/v14050893Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer ScreeningDaniëlle A. M. Heideman0Anja Oštrbenk Valenčak1Saskia Doorn2Jesper Bonde3Peter Hillemanns4Grega Gimpelj Domjanič5Jana Mlakar6Albertus T. Hesselink7Chris J. L. M. Meijer8Mario Poljak9Department of Pathology, Amsterdam UMC Location Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 Amsterdam, The NetherlandsInstitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, 1000 Ljubljana, SloveniaSelf-Screen, 1081 Amsterdam, The NetherlandsMolecular Pathology Laboratory, Department of Pathology, Hvidovre Hospital, 2650 Hvidovre, DenmarkDepartment of Gynecology and Obstetrics, Hannover Medical School, 30625 Hannover, GermanyInstitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, 1000 Ljubljana, SloveniaInstitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, 1000 Ljubljana, SloveniaSelf-Screen, 1081 Amsterdam, The NetherlandsDepartment of Pathology, Amsterdam UMC Location Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 Amsterdam, The NetherlandsInstitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, 1000 Ljubljana, SloveniaThe 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 <i>p</i> < 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.https://www.mdpi.com/1999-4915/14/5/893human papillomavirusNeuMoDx HPV Test Stripclinical performancereproducibilitycervical cancer screeningliquid medium |
| spellingShingle | Daniëlle A. M. Heideman Anja Oštrbenk Valenčak Saskia Doorn Jesper Bonde Peter Hillemanns Grega Gimpelj Domjanič Jana Mlakar Albertus T. Hesselink Chris J. L. M. Meijer Mario Poljak Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening Viruses human papillomavirus NeuMoDx HPV Test Strip clinical performance reproducibility cervical cancer screening liquid medium |
| title | Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening |
| title_full | Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening |
| title_fullStr | Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening |
| title_full_unstemmed | Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening |
| title_short | Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening |
| title_sort | clinical validation of the fully automated neumodx hpv assay for cervical cancer screening |
| topic | human papillomavirus NeuMoDx HPV Test Strip clinical performance reproducibility cervical cancer screening liquid medium |
| url | https://www.mdpi.com/1999-4915/14/5/893 |
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