Clinical performance of the Roche Cobas Liat SARS-CoV-2 & influenza A/B assay: A systematic review and meta-analysis

IF 4 3区 医学 Q2 VIROLOGY
Eunjin Chang , Kibum Jeon , Nuri Lee , Min-Jeong Park , Wonkeun Song , Hyun Soo Kim , Han-Sung Kim , Jae-Seok Kim , Jimin Kim , Seri Jeong
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引用次数: 0

Abstract

Respiratory tract infections caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza viruses are persistent and critical. The Cobas Liat SARS-CoV-2 & influenza A/B assay (Multiplex Liat), the FDA-authorized point-of-care reverse transcriptase polymerase chain reaction (RT-PCR) assay, has a turnaround time of 20 min and high accuracy. This study evaluates the pooled performance of this assay to provide practical information. This meta-analysis was registered in PROSPERO (registration number: CRD42023467579). A systematic literature search was conducted within PubMed, Ovid-EMBASE, and the Cochrane Library for articles evaluating the accuracy of the Multiplex Liat assay through September 2023. A random-effects model was used to calculate the pooled diagnostic values with real-time RT-PCR (rRT-PCR) as a reference test. A total of 4,705 samples from eight studies were included in the primary meta-analysis. The overall pooled sensitivity and specificity of Multiplex Liat were 100.0 % (95 % confidence interval [CI] = 96.7 %–100.0 %) and 99.7 % (95 % CI = 98.7 %–99.9 %), respectively. The presence of variants of concern or in-house rRT-PCR assays as reference standards did not significantly affect the pooled diagnostic performance of the Multiplex Liat. When 5,333 samples from nine studies were assessed for sensitivity, the pooled sensitivity was 100.0 % (95 % CI = 85.8 %–100.0 %) without a significant difference. This meta-analysis demonstrates the usefulness of Multiplex Liat for the detection of SARS-CoV-2 based on pooled diagnostic values. These practical findings may facilitate appropriate settings for the diagnosis and management of patients with respiratory tract infections.

罗氏 Cobas Liat SARS-CoV-2 和甲型/乙型流感检测试剂盒的临床性能:系统回顾与元分析
由严重急性呼吸系统综合征冠状病毒 2(SARS-CoV-2)和流感病毒引起的呼吸道感染是一种持久而严重的疾病。Cobas Liat SARS-CoV-2 & influenza A/B 分析法(Multiplex Liat)是美国食品及药物管理局(FDA)授权的护理点逆转录酶聚合酶链反应(RT-PCR)分析法,其检测时间仅为 20 分钟,准确度高。本研究对该检测方法的总体性能进行了评估,以提供实用信息。本荟萃分析已在 PROSPERO 注册(注册号:CRD42023467579)。我们在 PubMed、Ovid-EMBASE 和 Cochrane 图书馆中对 2023 年 9 月之前评估多重 Liat 检测法准确性的文章进行了系统性文献检索。采用随机效应模型计算以实时 RT-PCR(rRT-PCR)为参照检验的汇总诊断值。主要荟萃分析共纳入了八项研究的 4705 份样本。多重 Liat 的总体汇总灵敏度和特异性分别为 100.0%(95% 置信区间 [CI] = 96.7%-100.0%)和 99.7%(95% 置信区间 = 98.7%-99.9%)。值得关注的变异体或作为参考标准的内部 rRT-PCR 检测方法的存在并不会对多重 Liat 的综合诊断性能产生重大影响。在对九项研究中的 5,333 份样本进行灵敏度评估时,汇总灵敏度为 100.0 %(95 % CI = 85.8 %-100.0%),无明显差异。这项荟萃分析表明,根据综合诊断值,多重 Liat 检测 SARS-CoV-2 非常有用。这些实用的研究结果可能有助于对呼吸道感染患者进行适当的诊断和管理。
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来源期刊
Journal of Clinical Virology
Journal of Clinical Virology 医学-病毒学
CiteScore
22.70
自引率
1.10%
发文量
149
审稿时长
24 days
期刊介绍: The Journal of Clinical Virology, an esteemed international publication, serves as the official journal for both the Pan American Society for Clinical Virology and The European Society for Clinical Virology. Dedicated to advancing the understanding of human virology in clinical settings, the Journal of Clinical Virology focuses on disseminating research papers and reviews pertaining to the clinical aspects of virology. Its scope encompasses articles discussing diagnostic methodologies and virus-induced clinical conditions, with an emphasis on practicality and relevance to clinical practice. The journal publishes on topics that include: • new diagnostic technologies • nucleic acid amplification and serologic testing • targeted and metagenomic next-generation sequencing • emerging pandemic viral threats • respiratory viruses • transplant viruses • chronic viral infections • cancer-associated viruses • gastrointestinal viruses • central nervous system viruses • one health (excludes animal health)
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