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

IF 1.8 4区医学 Q3 INFECTIOUS DISEASES

Diagnostic microbiology and infectious disease Pub Date : 2026-03-01 Epub Date: 2025-11-26 DOI:10.1016/j.diagmicrobio.2025.117208

Taeyang Chin , Anja Oštrbenk , Nick Verhavert , Mario Poljak , Elizaveta Padalko

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引用次数: 0

Abstract

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.

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用于ASC-US / LSIL分诊的NeuMoDx HPV检测的多中心临床验证

NeuMoDx™HPV检测（QIAGEN， MI， USA）是一种PCR检测方法，可检测宫颈样本中的15种高危人乳头瘤病毒（HPV）类型，并单独鉴定HPV16和HPV18。虽然它已被证实用于原发性hpv为基础的宫颈癌筛查，但在细胞学为基础的筛查算法中，它在未确定意义的非典型鳞状细胞（ASC-US）或低级别鳞状上皮内病变（LSIL）的分类方面的表现尚未得到评估。这项多中心研究评估了NeuMoDx检测在ASC-US/LSIL分诊中的临床表现。对临床采集的447份剩余宫颈样本进行分析。在1号站点（卢布尔雅那，斯洛文尼亚），将NeuMoDx与Alinity m HR HPV检测（雅培分子，IL，美国）进行比较，在2号站点（根特，比利时），将其与APTIMA HPV检测（HOLOGIC， MA，美国）进行比较。NeuMoDx与Alinity的一致性为91.3% (95% CI: 858 -94.7%)，与APTIMA的一致性为96.2% (95% CI: 93.3-97.8%)，位点1的kappa值为0.824 (95% CI:0.737-0.912)，位点2的kappa值为0.779 （95% CI: 0.653-0.905）。与Alinity和Aptima相比，NeuMoDx检测宫颈上皮内瘤变2级及以上（CIN2+）的相对敏感性分别为0.91和1.08。NeuMoDx与Alinity的相对临床特异性为1.05，与Aptima的相对临床特异性为1.00。总之，NeuMoDx HPV检测在鉴别ASC-US/LSIL样本方面表现出可靠的临床性能。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diagnostic microbiology and infectious disease 医学-传染病学

CiteScore

5.30

自引率

3.40%

发文量

149

审稿时长

56 days

期刊介绍： Diagnostic Microbiology and Infectious Disease keeps you informed of the latest developments in clinical microbiology and the diagnosis and treatment of infectious diseases. Packed with rigorously peer-reviewed articles and studies in bacteriology, immunology, immunoserology, infectious diseases, mycology, parasitology, and virology, the journal examines new procedures, unusual cases, controversial issues, and important new literature. Diagnostic Microbiology and Infectious Disease distinguished independent editorial board, consisting of experts from many medical specialties, ensures you extensive and authoritative coverage.