Multi-centre clinical validation of the NeuMoDx HPV assay for ASC-US / LSIL triage.

The NeuMoDx™ HPV assay (QIAGEN, MI, USA) is a PCR assay that detects 15 high-risk human papillomavirus (HPV) types in cervical samples, with separate identification for HPV16 and HPV18. Although it has been validated for primary HPV-based cervical cancer screening, its performance in the triage of atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL) in cytology-based screening algorithms has not yet been evaluated. This multicentre study assessed the clinical performance of the NeuMoDx assay for ASC-US/LSIL triage. A total of 447 residual clinician-collected cervical samples were analysed. At site 1 (Ljubljana, Slovenia), NeuMoDx was compared with the Alinity m HR HPV assay (Abbott Molecular, IL, USA), and at site 2 (Ghent, Belgium), it was compared with the APTIMA HPV assay (HOLOGIC, MA, USA). NeuMoDx demonstrated 91.3% (95% CI: 85.8-94.7%) concordance with Alinity and 96.2% (95% CI: 93.3-97.8%) concordance with APTIMA, with excellent kappa values of 0.824 (95% CI:0.737-0.912) for site 1 and 0.779 (95% CI: 0.653-0.905) for site 2. The relative sensitivity of NeuMoDx for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+) was 0.91 and 1.08 compared to Alinity and Aptima, respectively. Relative clinical specificity of NeuMoDx was 1.05 compared to Alinity and 1.00 compared to Aptima. In conclusion, the NeuMoDx HPV assay showed reliable clinical performance in triaging ASC-US/LSIL samples.