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20 种快速抗原检测试剂在 2022 年 1 月临床标本中的表现,用于检测 SARS-CoV-2 B.1.617.2(德尔塔)和 B.1.1.529(奥密克戎)变异株,德国柏林。

Performance of 20 rapid antigen detection tests to detect SARS-CoV-2 B.1.617.2 (Delta) and B.1.1.529 (Omicron) variants using a clinical specimen panel from January 2022, Berlin, Germany.

机构信息

Robert Koch Institute, Highly Pathogenic Viruses, Centre for Biological Threats and Special Pathogens, WHO Reference Laboratory for SARS-CoV-2 and WHO Collaborating Centre for Emerging Infections and Biological Threats, Berlin, Germany.

Paul-Ehrlich-Institute, Testing Laboratory for In-vitro Diagnostic Medical Devices, Langen, Germany.

出版信息

Euro Surveill. 2023 Apr;28(16). doi: 10.2807/1560-7917.ES.2023.28.16.2200615.


DOI:10.2807/1560-7917.ES.2023.28.16.2200615
PMID:37078884
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10283455/
Abstract

BackgroundThere are conflicting reports on the performance of rapid antigen detection tests (RDT) in the detection of the SARS-CoV-2 Omicron (B.1.1.529) variant; however, these tests continue to be used frequently to detect potentially contagious individuals with high viral loads.AimThe aim of this study was to investigate comparative detection of the Delta (B.1.617.2) and Omicron variants by using a selection of 20 RDT and a limited panel of pooled combined oro- and nasopharyngeal clinical Delta and Omicron specimens.MethodsWe tested 20 CE-marked RDT for their performance to detect SARS-CoV-2 Delta and Omicron by using a panel of pooled clinical specimens collected in January 2022 in Berlin, Germany.ResultsWe observed equivalent detection performance for Delta and Omicron for most RDT, and sensitivity was widely in line with our previous pre-Delta/Omicron evaluation. Some variation for individual RDT was observed either for Delta vs Omicron detection, or when compared with the previous evaluation, which may be explained both by different panel sizes resulting in different data robustness and potential limitation of batch-to-batch consistency. Additional experiments with three RDT using non-pooled routine clinical samples confirmed comparable performance to detect Delta vs Omicron. Overall, RDT that were previously positively evaluated retained good performance also for Delta and Omicron variants.ConclusionOur findings suggest that currently available RDT are sufficient for the detection of SARS-CoV-2 Delta and Omicron variants.

摘要

背景:关于快速抗原检测(RDT)在检测 SARS-CoV-2 奥密克戎(B.1.1.529)变异株方面的性能,存在相互矛盾的报告;然而,这些检测方法仍被频繁用于检测具有高病毒载量的潜在传染性个体。

目的:本研究旨在通过使用一组 20 种 RDT 和一组有限的奥密克戎和德尔塔混合鼻咽部临床标本,研究比较检测德尔塔(B.1.617.2)和奥密克戎变异株的能力。

方法:我们使用德国柏林于 2022 年 1 月收集的一组临床标本,对 20 种获得 CE 标志的 RDT 进行了检测,以评估其对 SARS-CoV-2 德尔塔和奥密克戎的检测性能。

结果:我们观察到大多数 RDT 对德尔塔和奥密克戎的检测性能相当,灵敏度与我们之前对德尔塔/奥密克戎的评估广泛一致。对于个别 RDT,我们观察到在德尔塔与奥密克戎检测之间,或者与之前的评估相比,存在一定的差异,这可能是由于不同的面板大小导致数据稳健性不同,以及批次间一致性的潜在限制。使用三种非混合常规临床样本的 RDT 的额外实验证实了对德尔塔与奥密克戎检测的可比性能。总体而言,以前经过积极评估的 RDT 对德尔塔和奥密克戎变异株的性能也保持良好。

结论:我们的研究结果表明,目前可用的 RDT 足以检测 SARS-CoV-2 德尔塔和奥密克戎变异株。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/717f/10283455/0872c027cc2c/2200615-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/717f/10283455/7beee8a3da50/2200615-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/717f/10283455/0872c027cc2c/2200615-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/717f/10283455/7beee8a3da50/2200615-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/717f/10283455/0872c027cc2c/2200615-f2.jpg

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[4]
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本文引用的文献

[1]
SARS-CoV-2 rapid antigen test sensitivity and viral load in newly symptomatic hospital employees in Berlin, Germany, December, 2020 to February, 2022: an observational study.

Lancet Microbe. 2024-6

[2]
Outbreak.info genomic reports: scalable and dynamic surveillance of SARS-CoV-2 variants and mutations.

Nat Methods. 2023-4

[3]
Comparison of Rapid Antigen Tests' Performance Between Delta and Omicron Variants of SARS-CoV-2 : A Secondary Analysis From a Serial Home Self-testing Study.

Ann Intern Med. 2022-12

[4]
Analytical Sensitivity of Eight Different SARS-CoV-2 Antigen-Detecting Rapid Tests for Omicron-BA.1 Variant.

Microbiol Spectr. 2022-8-31

[5]
Evaluation of Four Point of Care (POC) Antigen Assays for the Detection of the SARS-CoV-2 Variant Omicron.

Microbiol Spectr. 2022-6-29

[6]
Analytical Sensitivity of Six SARS-CoV-2 Rapid Antigen Tests for Omicron versus Delta Variant.

Viruses. 2022-3-22

[7]
Limit of Detection for Rapid Antigen Testing of the SARS-CoV-2 Omicron and Delta Variants of Concern Using Live-Virus Culture.

J Clin Microbiol. 2022-5-18

[8]
Comparison of SARS-CoV-2 Reverse Transcriptase Polymerase Chain Reaction and BinaxNOW Rapid Antigen Tests at a Community Site During an Omicron Surge : A Cross-Sectional Study.

Ann Intern Med. 2022-5

[9]
Real-life performance of a COVID-19 rapid antigen detection test targeting the SARS-CoV-2 nucleoprotein for diagnosis of COVID-19 due to the Omicron variant.

J Infect. 2022-5

[10]
Impaired detection of omicron by SARS-CoV-2 rapid antigen tests.

Med Microbiol Immunol. 2022-6

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