BD Veritor™SARS-CoV-2护理点检测的临床评价

IF 1.4 Q4 INFECTIOUS DISEASES

Journal of clinical virology plus Pub Date : 2026-06-01 Epub Date: 2026-02-02 DOI:10.1016/j.jcvp.2026.100242

Jesse Young , Ashley Orlowski , Karen Yanson , Katherine Christensen

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引用次数: 0

摘要

鉴于COVID-19目前处于流行阶段，保持强大的诊断能力对于持续监测和及时应对潜在的感染高峰仍然至关重要。目的评估更新后的BD Veritor™SARS-CoV-2检测系统（Veritor; Becton Dickinson and Company, BD Life Sciences-Diagnostic Solutions, San Diego， CA）与比较物Panther Fusion （Fusion; Hologic Inc., San Diego， CA）的性能和监管性能标准。这项前瞻性临床研究在美国15个地点招募了1181名有SARS-CoV-2症状的个体。医疗保健提供者从年龄≥6个月且症状发作(DSO)≤7天的参与者中收集双鼻样本，以确定Veritor与Fusion的诊断准确性，并根据先前清除的SARS-CoV-2抗原检测确定预期的监管性能标准。结果在1045例符合要求和可报告的标本中，Veritor的总体阳性满意率（PPA）为83.4% [95% CI；76.6, 88.6]和负百分比协议（NPA）为99.7% [95% CI；99.0、99.9)。表现因DSO而异，PPA越高越接近症状发作，病毒载量（以Fusion Ct评分为特征）也不同，Ct评分越低Veritor表现越好。Veritor符合0-7 DSO范围内SARS-CoV-2抗原检测的监管（FDA 510(k)）接受标准。结论Veritor试验可以快速、准确地检测出SARS-CoV-2抗原，且易于收集鼻拭子。

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Clinical evaluation of the BD Veritor™ SARS-CoV-2 point-of-care test

BACKGROUND

Whereas COVID-19 is now in the endemic phase, maintaining robust diagnostic capabilities remains critical for ongoing surveillance and timely response to potential infection spikes.

OBJECTIVE

To evaluate the performance of the updated BD Veritor™ System for SARS-CoV-2 (Veritor; Becton Dickinson and Company, BD Life Sciences—Diagnostic Solutions, San Diego, CA ) assay against a comparator, the Panther Fusion (Fusion; Hologic Inc., San Diego, CA) and regulatory performance criteria.

METHODS

This prospective, clinical study enrolled 1,181 SARS-CoV-2 symptomatic individuals across 15 U.S. sites. Healthcare providers collected dual nares samples from participants ≥6 months of age and ≤7 days from symptom onset (DSO) to determine diagnostic accuracy of Veritor compared to Fusion and expected regulatory performance criteria per previously cleared SARS-CoV-2 antigen assays.

RESULTS

Of 1,045 compliant and reportable specimens, Veritor had an overall positive percent agreement (PPA) of 83.4% [95% CI; 76.6, 88.6] and a negative percent agreement (NPA) of 99.7% [95% CI; 99.0, 99.9]. Performance varied by DSO, with higher PPA closer to symptom onset, and by viral load (characterized by Fusion Ct score), with lower Ct scores associated with better Veritor performance. Veritor met the regulatory (FDA 510(k)) acceptance criteria for SARS-CoV-2 antigen testing for the 0-7 DSO range.