Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening
Abstract
:1. Introduction
2. Materials and Methods
2.1. NeuMoDx HPV Assay
2.2. Clinical Specimens
2.2.1. Group 1 (PreservCyt Collection Medium)
2.2.2. Group 2 (SurePath Collection Medium)
2.3. Data and Statistical Analyses
3. Results
3.1. Clinical Accuracy and Assay Reproducibility According to the International Guidelines on PreservCyt Cervical Specimens (Group 1)
3.2. Clinical Accuracy of the NeuMoDx HPV Assay for SurePath Cervical Specimens (Group 2)
3.3. Clinical Performance for CIN2+ of NeuMoDx HPV Assay in Relation to Other HPV Tests for PreservCyt Cervical Specimens (Group 1)
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Reference Assay Hybrid Capture 2 | Non-Inferiority Score Test (p-Value) | ||||
---|---|---|---|---|---|
Negative | Positive | Total | |||
Women with ≤CIN1 | |||||
NeuMoDx HPV assay | Negative | 746 | 26 ## | 772 | 0.0001 |
Positive | 5 # | 24 | 29 | ||
Total | 751 | 50 | 801 | ||
Women with CIN2+ | |||||
NeuMoDx HPV assay | Negative | 1 | 2 ** | 3 | 0.018 |
Positive | 1 * | 63 | 64 | ||
Total | 2 | 65 | 67 |
Lab 1/Run 1 | Lab 1/Run 2 | Total | Lab 2 | Total | ||
---|---|---|---|---|---|---|
Negative | Positive | Negative | Positive | |||
Negative | 335 | 13 | 348 | 342 | 6 | 348 |
Positive | 9 | 152 | 161 | 22 | 139 | 161 |
Total | 344 | 165 | 509 | 364 | 145 | 509 |
Agreement | 95.7% (95% CI: 93.9–97.3) | 94.5% (95% CI: 92.6–96.2) | ||||
Kappa value | 0.90 (95% CI: 0.86–0.94) | 0.87 (95% CI: 0.82–0.92) |
Lab 1/Run 1 | Lab 1/Run 2 | Total | |||||||
---|---|---|---|---|---|---|---|---|---|
Negative | HPV16 | HPV18 | Other HPV | HPV16 and 18 | HPV16 and Other | HPV18 and Other | HPV16, 18 and Other | ||
Negative | 335 | 2 | - | 11 | - | - | - | - | 348 |
HPV16 | - | 46 | - | - | - | 1 | - | - | 47 |
HPV18 | - | - | 2 | - | - | - | - | - | 2 |
Other HPV | 9 | - | - | 78 | - | - | - | - | 87 |
HPV16 and 18 | - | - | 1 | - | 3 | - | - | - | 4 |
HPV16 and other | - | 1 | - | - | - | 18 | - | - | 19 |
HPV18 and other | - | - | - | - | - | - | 1 | - | 1 |
HPV16, 18 and other | - | - | - | - | - | - | - | 1 | 1 |
Total | 344 | 49 | 3 | 89 | 3 | 19 | 1 | 1 | 509 |
Lab 1/Run 1 | Lab 2 | Total | |||||||
---|---|---|---|---|---|---|---|---|---|
Negative | HPV16 | HPV18 | Other HPV | HPV16 and 18 | HPV16 and Other | HPV18 and Other | HPV16, 18 and Other | ||
Negative | 342 | - | - | 6 | - | - | - | - | 348 |
HPV16 | - | 47 | - | - | - | - | - | - | 47 |
HPV18 | - | - | 2 | - | - | - | - | - | 2 |
Other HPV | 22 | - | - | 65 | - | - | - | - | 87 |
HPV16 and 18 | - | - | 1 | - | 2 | - | - | 1 | 4 |
HPV16 and other | - | 3 | - | - | - | 16 | - | - | 19 |
HPV18 and other | - | - | - | - | - | - | 1 | - | 1 |
HPV16, 18 and other | - | - | - | - | - | - | - | 1 | 1 |
Total | 364 | 50 | 3 | 71 | 2 | 16 | 1 | 2 | 509 |
Reference Assay HPV-Risk Assay | Non-Inferiority Score Test (p-Value) | ||||
---|---|---|---|---|---|
Negative | Positive | Total | |||
Women with ≤CIN1 | |||||
NeuMoDx HPV assay | Negative | 756 | 19 ## | 775 | <0.0001 |
Positive | 6 ^ | 48 | 54 | ||
Total | 762 | 67 | 829 | ||
Women with CIN2+ | |||||
NeuMoDx HPV assay | Negative | 7 | 1 * | 8 | 0.0009 |
Positive | 1 # | 97 | 98 | ||
Total | 8 | 98 | 106 |
Comparator Assay COBAS 4800 HPV Assay | Non-Inferiority Score Test (p-Value) | ||||
---|---|---|---|---|---|
Negative | Positive | Total | |||
Women with ≤CIN1 | |||||
NeuMoDx HPV assay | Negative | 751 | 21 ## | 772 | 0.006 |
Positive | 7 # | 22 | 29 | ||
Total | 758 | 43 | 801 | ||
Women with CIN2+ | |||||
NeuMoDx HPV assay | Negative | 2 | 1 * | 3 | 0.011 |
Positive | - | 64 | 64 | ||
Total | 2 | 65 | 67 |
Comparator Assay Alinity HPV Assay | Non-Inferiority Score Test (p-Value) | ||||
---|---|---|---|---|---|
Negative | Positive | Total | |||
Women with ≤CIN1 | |||||
NeuMoDx HPV assay | Negative | 743 | 29 ## | 772 | <0.0001 |
Positive | 6 # | 23 | 29 | ||
Total | 749 | 52 | 801 | ||
Women with CIN2+ | |||||
NeuMoDx HPV assay | Negative | 1 | 2 * | 3 | 0.03 |
Positive | - | 64 | 64 | ||
Total | 1 | 66 | 67 |
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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. Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening. Viruses 2022, 14, 893. https://doi.org/10.3390/v14050893
Heideman DAM, Oštrbenk Valenčak A, Doorn S, Bonde J, Hillemanns P, Gimpelj Domjanič G, Mlakar J, Hesselink AT, Meijer CJLM, Poljak M. Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening. Viruses. 2022; 14(5):893. https://doi.org/10.3390/v14050893
Chicago/Turabian StyleHeideman, Daniëlle A. M., Anja Oštrbenk Valenčak, Saskia Doorn, Jesper Bonde, Peter Hillemanns, Grega Gimpelj Domjanič, Jana Mlakar, Albertus T. Hesselink, Chris J. L. M. Meijer, and Mario Poljak. 2022. "Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening" Viruses 14, no. 5: 893. https://doi.org/10.3390/v14050893
APA StyleHeideman, 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