Development and Diagnosis Performance of IgM-Based Rapid Antigen Test for Early Detection of SARS-CoV-2 Infection in a Large Cohort of Suspected COVID-19 Cases - USA, Poland, and Sweden, 2021-2022.

IF 4.3 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

中国疾病预防控制中心周报 Pub Date : 2024-09-13 DOI:10.46234/ccdcw2024.199

Yihua Huang, Yiyi Pu, Youhong Weng, Yahan Wu, Qing He, Sofia Litchev, Longyou Zhao, Haojie Ding, Yunru Lai, Jie Li, Xiaojun Zheng, Jinshu Chen, Xianqin Xiong, Shaohong Lu, Fei Gao, Meng Gao, Qingming Kong

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引用次数: 0

Abstract

Introduction: Antigen testing has been crucial in effectively managing the coronavirus disease 2019 (COVID-19) pandemic. This study evaluated the clinical performance of a nasopharyngeal swab (NPS)-based antigen rapid diagnostic test (Ag-RDT) compared to the gold standard real-time reverse transcription-polymerase chain reaction (RT-PCR) for early detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Methods: We developed an IgM-based rapid antigen test for early detection of SARS-CoV-2 infection. Between July 2021 and January 2022, we analyzed 1,030 NPS samples from participants at three centers in different countries, using both antigen rapid diagnostic tests (Ag-RDT) and RT-PCR.

Results: The Ag-RDT demonstrated minimal detection limits as low as 0.1 ng/mL for recombinant N antigen and 100 TCID50/mL for heat-inactivated SARS-CoV-2 virus. Specificity assessments involving four human coronaviruses and 13 other respiratory viruses showed no cross-reactivity. The Ag-RDT assay (ALLtest) exhibited high sensitivity (93.18%-100%) and specificity (99.67%-100%) across all centers. Factors such as cycle threshold (Ct) values and the timing of symptoms since onset were influential, with sensitivity increasing at lower Ct values (<30) and within the first week of symptoms.

Conclusion: The ALLtest Ag-RDT demonstrated high reliability and significant potential for diagnosing suspected COVID-19 cases.

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2021-2022 年，在美国、波兰和瑞典的一大批 COVID-19 疑似病例中开发基于 IgM 的快速抗原检测试剂盒，用于早期检测 SARS-CoV-2 感染。

导言：抗原检测对于有效控制 2019 年冠状病毒病（COVID-19）大流行至关重要。本研究评估了基于鼻咽拭子（NPS）的抗原快速诊断检测（Ag-RDT）与金标准实时反转录聚合酶链反应（RT-PCR）相比在早期检测严重急性呼吸系统综合征冠状病毒2（SARS-CoV-2）方面的临床表现：我们开发了一种基于 IgM 的快速抗原检测方法，用于早期检测 SARS-CoV-2 感染。2021 年 7 月至 2022 年 1 月期间，我们使用抗原快速诊断检测（Ag-RDT）和 RT-PCR 分析了来自不同国家三个中心的 1030 份非典型肺炎样本：结果：抗原快速诊断检测（Ag-RDT）显示，重组 N 抗原的最小检测限低至 0.1 纳克/毫升，热灭活 SARS-CoV-2 病毒的最小检测限为 100 TCID50/毫升。对四种人类冠状病毒和 13 种其他呼吸道病毒进行的特异性评估显示没有交叉反应。Ag-RDT检测法（ALLtest）在所有中心都表现出较高的灵敏度（93.18%-100%）和特异性（99.67%-100%）。周期阈值（Ct）值和发病时间等因素都有影响，Ct值越低，灵敏度越高（结论：ALLtest Ag-RDT检测的灵敏度和特异性都很高：ALLtest Ag-RDT在诊断COVID-19疑似病例方面表现出高度可靠性和巨大潜力。

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

中国疾病预防控制中心周报

CiteScore

5.90

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0.00%

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