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  

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

机构地区：[1]Department of Laboratory Medicine,Lishui Second People's Hospital Affiliated to Wenzhou Medical University,Lishui City,Zhejiang Province,China [2]Key Laboratory of Biomarkers and In Vitro Diagnosis Translation of Zhejiang province,School of Laboratory Medicine and Bioengineering,Hangzhou Medical College,Hangzhou City,Zhejiang Province,China [3]School of Basic Medicine and Forensics,Key Laboratory of Bio-tech Vaccine of Zhejiang Province,Engineering Research Center of Novel Vaccine of Zhejiang Province,Hangzhou Medical College,Hangzhou City,Zhejiang Province,China [4]The Fifth Affiliated Hospital of Wenzhou Medical University,Lishui City,Zhejiang Province,China [5]Baylor College of Medicine,Houston,TX,USA [6]Department of Research and Development,Hangzhou AllTest Biotech Co.,Ltd,Hangzhou City,Zhejiang Province,China

出　　处：《China CDC weekly》2024年第37期953-961,I0009,I0010,共11页中国疾病预防控制中心周报（英文）

基　　金：Supported by the Zhejiang Provincial Program for the Cultivation of High-level Innovative Health Talents(WJW2021002);Science Foundation of National Health Commission of the PRC(WJWZJ-2203);the Key R&D projects of Zhejiang Province(2022C03109);the S&T Major Project of Lishui(2023GYX03);the National Health Commission Research fund(WKJ-ZJ-2421).

摘　　要：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.

关 键 词：ANTIGEN SPECIFICITY CENTERS 

分 类 号：R563.1[医药卫生—呼吸系统]