A multicenter study to assess the performance of the point-of-care RT-PCR Cobas SARS-CoV-2 & Influenza A/B nucleic acid test for use on the Cobas Liat system in comparison with centralized assays across healthcare facilities in the United States.

IF 6.1 2区 医学 Q1 MICROBIOLOGY
Elissa M Robbins, Rasa Bertuzis, Ho-Chen Chiu, Lupe Miller, Christopher Noutsios
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引用次数: 0

Abstract

Respiratory diseases can share many of the same symptoms, highlighting the need for timely and accurate differentiation to facilitate effective clinical management and reduce transmission. Compared with centralized testing, molecular point-of-care tests (POCTs) can provide a faster time to result. We evaluated the RT-PCR POCT Cobas® SARS-CoV-2 & Influenza A/B qualitative assay for use on the Cobas Liat system (the POC SARS-CoV-2 & Influenza A/B test) in nasal and nasopharyngeal swab samples from 10 diverse healthcare facilities in the United States. A composite comparator design consisting of three centralized tests was used to analyze severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), while performance vs a single centralized test was used for analysis of influenza A and B. Evaluations included performance stratified by sample type (prospective/retrospective and nasal/nasopharyngeal [paired by subject]), collection method (self/healthcare worker-collected [alternated and approximately balanced]), symptom status (symptomatic/asymptomatic), and SARS-CoV-2 vaccination status, as well as assay inclusivity and system ease of use. A total of 2,247 samples were tested. For SARS-CoV-2, the overall percent agreement (OPA) was 98.8% (95% confidence interval [CI]: 97.9, 99.3) in nasal swab samples and 99.0% (95% CI: 98.2, 99.4) in nasopharyngeal swab samples. Regression analysis showed that cycle threshold values from paired nasal and nasopharyngeal swab samples were highly correlated (correlation coefficient 0.83). The OPA was ≥99.5% (sample type dependent) and 100.0% for influenza A and B, respectively. The POC SARS-CoV-2 & Influenza A/B test was easy to use. These results support the use of the POCT in various sample types and by various operators in the intended-use setting.

Importance: This study highlights the benefits of RT-PCR point-of-care tests, namely comparable performance to centralized testing in multiple sample types and ease of use. Utilizing assays such as the POC Cobas SARS-CoV-2 & Influenza A/B test may improve the timely differentiation of respiratory diseases that share similar symptoms.

一项多中心研究,旨在评估在Cobas Liat系统上使用的即时即时RT-PCR Cobas SARS-CoV-2和流感A/B核酸检测的性能,并与美国各医疗机构的集中检测进行比较。
呼吸系统疾病可能有许多相同的症状,因此需要及时和准确地进行区分,以促进有效的临床管理和减少传播。与集中检测相比,分子护理点检测(POCTs)可以提供更快的结果。我们评估了RT-PCR POCT Cobas®SARS-CoV-2和流感A/B定性分析,用于Cobas Liat系统(POC SARS-CoV-2和流感A/B测试)中来自美国10个不同医疗机构的鼻和鼻咽拭子样本。采用由三个集中试验组成的复合比较设计来分析严重急性呼吸综合征冠状病毒2型(SARS-CoV-2),而采用性能与单一集中试验的比较设计来分析甲型和乙型流感。评估包括按样本类型(前瞻性/回顾性和鼻/鼻咽[按受试者配对])、收集方法(自我/卫生保健工作者收集[交替和大致平衡])、症状状态(有症状/无症状)和SARS-CoV-2疫苗接种状态,以及检测包容性和系统易用性。共检测了2247个样本。对于SARS-CoV-2,鼻拭子样本的总体一致性百分比(OPA)为98.8%(95%置信区间[CI]: 97.9, 99.3),鼻咽拭子样本的总体一致性百分比(OPA)为99.0% (95% CI: 98.2, 99.4)。回归分析显示,配对鼻拭子和鼻咽拭子样本的周期阈值高度相关(相关系数0.83)。甲型流感和乙型流感的OPA分别≥99.5%(取决于样本类型)和100.0%。POC SARS-CoV-2 &流感A/B检测操作简便。这些结果支持在不同的样本类型和不同的操作人员在预期使用设置中使用POCT。重要性:本研究强调了RT-PCR即时检测的优势,即与多种样品类型的集中检测性能相当,且易于使用。利用诸如POC Cobas SARS-CoV-2和流感A/B测试等检测方法可以提高对具有相似症状的呼吸道疾病的及时区分。
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
Journal of Clinical Microbiology
Journal of Clinical Microbiology 医学-微生物学
CiteScore
17.10
自引率
4.30%
发文量
347
审稿时长
3 months
期刊介绍: The Journal of Clinical Microbiology® disseminates the latest research concerning the laboratory diagnosis of human and animal infections, along with the laboratory's role in epidemiology and the management of infectious diseases.
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