Validation of the clinical performance and reproducibility of the NeuMoDx HPV assay self-sample workflow.

Background: Human papillomavirus (HPV) testing on self-samples is a valid tool for cervical cancer screening. HPV self-sample workflows need to be clinically validated to ensure safe use in screening.
Objective: This study evaluated the fully automated NeuMoDx HPV Assay self-sample workflow that is compiled of the NeuMoDx HPV assay and the NeuMoDx 96/288 Molecular Systems, for clinical performance and reproducibility on Evalyn Brush-collected self-samples.
Methods: The clinical performance of the NeuMoDx HPV Assay self-sample workflow for cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and CIN3+ was evaluated on 987 self-samples obtained from women attending national organized HPV-based cervical cancer screening by a noninferiority analysis relative to reference workflows using either HPV-Risk Assay or high-risk HPV GP5+/6+-PCR. Intra- and inter-laboratory reproducibility of the NeuMoDx HPV Assay self-sample workflow using both NeuMoDx 96 and 288 Molecular Systems was assessed on 520 self-samples in three laboratories.
Results: The clinical sensitivity and specificity of the NeuMoDx HPV Assay self-sample workflow for the detection of CIN2+ and CIN3+ were found to be non-inferior to the reference workflows using either HPV-Risk Assay or high-risk HPV GP5+/6+-PCR, with all p-values <0.034. The NeuMoDx HPV Assay self-sample workflow exhibited an intra-laboratory reproducibility of 94.4 % (95 %CI:92.5-96.1 %) with kappa value 0.86 (95 %CI:0.81-0.91). Inter-laboratory agreement was high (all ≥93.4 % and all kappa values ≥0.83).
Conclusions: The NeuMoDx HPV Assay self-sample workflow demonstrated high clinical accuracy for CIN2+/3+ and high reproducibility. The NeuMoDx HPV Assay self-sample workflow can be considered suitable for cervical cancer screening purposes.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: (1) DAMH and RDMS are minority shareholders of Self-screen B.V., a spin-off company of VUmc (currently known as Amsterdam UMC, Vrije Universiteit Amsterdam); Self-screen B.V. develops, manufactures and licenses high-risk HPV and methylation marker assays for cervical cancer screening and holds patents on these tests; (2) JB had financial support from the European Commission (RISCC, grant number 847845); (3) AOV has received reimbursement of travel expenses for attending conferences and honoraria for speaking from Abbott Molecular, Qiagen and Seegene; (4) MP, AOV and JM are supported by the Horizon 2020 Framework Program for Research and Innovation of the European Commission, through the RISCC Network (grant no. 847845) and by the Slovenian Research Agency (grant no. P3–00083); (5) MP and JM declare no personal conflicts of interest. MP's, AOV's and JM's institution received research funding, free-of-charge reagents, and consumables to support research in the last 3 years from Qiagen, Seegene, Abbott, and Roche, all paid to their employer; and (6) all other authors declare no conflicts of interest.
(Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)