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呼吸道样本中 SARS-CoV-2 和流感 A/B 的多重快速抗原检测评估。

Evaluation of Multiplex Rapid Antigen Test for the Detection of SARS-CoV-2 and Influenza A/B in Respiratory Samples.

出版信息

Clin Lab. 2024 Mar 1;70(3). doi: 10.7754/Clin.Lab.2023.231003.

Abstract

BACKGROUND

There is little data about the performance of multiplex rapid antigen tests (RATs) on the detection of SARS-CoV-2, influenza A (Flu A), and influenza B (Flu B). This study is to evaluate the performance of Panbio COVID-19/Flu A&B rapid panel (Abbott Diagnostics, Korea) and analyze the factors influencing its sensitivity.

METHODS

Nasopharyngeal swabs were collected and stored at the Korea University Anam hospital. In total, 400 residual samples from nasopharyngeal swabs were examined. The diagnostic accuracy of RAT was compared to that of RT-qPCR using the Allplex SARS-CoV-2/FluA/FluB/RSV Assay (Seegene, Seoul, South Korea).

RESULTS

Panbio COVID-19/Flu A&B rapid panel showed the sensitivities of 88.0%, 92.0%, and 100% for SARS-CoV-2, Flu A, and Flu B, respectively, and specificities of 100% for all. The agreements with previously licensed single-plex RATs were shown to be high. In the analysis of variables affecting sensitivity, inappropriate sampling time after symptom onset (STASO) and high cycle threshold (Ct value) were shown to negatively affect the sensi-tivity.

CONCLUSIONS

In conclusion, the multiplex RAT is useful for diagnosing SARS-CoV-2 and Flu A/B, but more clinical studies are needed.

摘要

背景

关于多重快速抗原检测(RAT)在检测 SARS-CoV-2、甲型流感(Flu A)和乙型流感(Flu B)方面的性能,数据很少。本研究旨在评估 Panbio COVID-19/Flu A&B 快速检测试剂盒( Abbott Diagnostics,韩国)的性能,并分析影响其敏感性的因素。

方法

收集鼻咽拭子并储存在韩国大学安岩医院。总共检查了 400 个来自鼻咽拭子的剩余样本。使用 Allplex SARS-CoV-2/FluA/FluB/RSV 检测试剂盒(Seegene,首尔,韩国)比较 RAT 的诊断准确性和 RT-qPCR。

结果

Panbio COVID-19/Flu A&B 快速检测试剂盒对 SARS-CoV-2、Flu A 和 Flu B 的敏感性分别为 88.0%、92.0%和 100%,特异性均为 100%。与先前获得许可的单重 RAT 的一致性较高。在分析影响敏感性的变量时,症状出现后采样时间不当(STASO)和高循环阈值(Ct 值)被证明会对敏感性产生负面影响。

结论

总之,多重 RAT 可用于诊断 SARS-CoV-2 和 Flu A/B,但需要更多的临床研究。

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