Clinical practice of rapid antigen tests for SARS-CoV-2 Omicron variant: A single-center study in China

Mengyuan Chen; Jiaqin Xu; Lingjun Ying; Miaoguo Cai; Tao-Hsin Tung; Kai Zhou; Yufen Zheng; Xiaojie Bi; Jing Wang; Xi Tu; Bo Shen; Dongqing Lv

doi:10.1016/j.virs.2022.08.008

December 2022

. doi: 10.1016/j.virs.2022.08.008

Citation: Mengyuan Chen, Jiaqin Xu, Lingjun Ying, Miaoguo Cai, Tao-Hsin Tung, Kai Zhou, Yufen Zheng, Xiaojie Bi, Jing Wang, Xi Tu, Bo Shen, Dongqing Lv. Clinical practice of rapid antigen tests for SARS-CoV-2 Omicron variant: A single-center study in China .VIROLOGICA SINICA, 2022, 37(6) : 842-849. http://dx.doi.org/10.1016/j.virs.2022.08.008

新型冠状病毒奥密克戎变异株快速抗原检测的临床实践：在中国开展的一项单中心研究

陈梦媛 ^a ,
徐加勤 ^a ,
应灵军 ^b ,
蔡妙国 ^c ,
董道興 ^d ,
周凯 ^a ,
郑玉芬 ^a ,
毕晓洁 ^a ,
王静 ^a ,
涂茜 ^a ,
沈波 ^a,, ,
吕冬青 ^e,,

a 温州医科大学附属浙江省台州医院检验科,台州,317000,中国;
b 温州医科大学附属浙江省台州医院肝病科和感染科,台州,317000,中国;
c 温州医科大学附属浙江省台州医院放疗科,台州,317000,中国;
d 温州医科大学附属浙江省台州医院循证医学中心,台州,317000,中国;
e 温州医科大学附属浙江省台州医院呼吸与危重症医学科,台州,317000,中国

通讯作者： 沈波, shenb@enzemed.com; 吕冬青, lvdq@enzemed.com
收稿日期： 2022-05-25
录用日期： 2022-08-23

摘要

为了应对新型冠状病毒奥密克戎变异株的快速传播，提升筛查出新型冠状病毒感染者的能力非常重要。中国在2022年3月中旬首次将快速抗原检测（Rapid antigen test,RAT）作为补充检测方法。回答“RAT在中国将应当扮演什么角色并发挥多大的作用”这个问题亟需临床数据的支持。在本研究中，我们以核酸扩增检测（Nucleic acid amplification test,NAAT）作为标准，在奥密克戎变异株感染的住院病人中评价了RAT的性能和影响其检测的相关因素。NAAT的结果表明鼻咽拭子的检测效果优于口咽拭子。RAT在NAAT阳性的鼻咽拭子样本中的检测性能优于NAAT阳性的口咽拭子。RAT阳性率与鼻咽拭子样本中新型冠状病毒N基因和ORF1ab基因的高水平高度相关，与病人长住院时长、检测距离症状初发时间短高度相关。当受试者接受了良好的RAT检测指导，自行RAT检测（含自行采样）的准确率与专业人员进行RAT检测的准确率可比。本研究纳入的病人在出院时RAT阴性率为100%。这些结果提示：RAT除了作为一种补充检测手段，也可能成为评估奥密克戎变异株感染的住院病人疾病进展的重要策略。本研究为中国新型冠状病毒肺炎动态清零政策下RAT的政策优化提供了重要的支撑性临床数据。
- 新型冠状病毒奥密克戎变异株
- , 快速抗原检测
- , 新型冠状病毒肺炎动态清零政策
- , 新型冠状病毒肺炎进展评估

Clinical practice of rapid antigen tests for SARS-CoV-2 Omicron variant: A single-center study in China

Mengyuan Chen ^a ,
Jiaqin Xu ^a ,
Lingjun Ying ^b ,
Miaoguo Cai ^c ,
Tao-Hsin Tung ^d ,
Kai Zhou ^a ,
Yufen Zheng ^a ,
Xiaojie Bi ^a ,
Jing Wang ^a ,
Xi Tu ^a ,
Bo Shen ^a,, ,
Dongqing Lv ^e,,

a Department of Laboratory Medicine, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, 317000, China;
b Hepatology and Infectious Diseases Center, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, 317000, China;
c Department of Radiation Oncology, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, 317000, China;
d Evidence-based Medicine Center, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, 317000, China;
e Department of Respiratory and Critical Diseases, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, 317000, China

Corresponding author: Bo Shen, shenb@enzemed.com Dongqing Lv, lvdq@enzemed.com
Received Date: 25 May 2022
Accepted Date: 23 August 2022

Abstract

Responding to the fast-spreading SARS-CoV-2 Omicron variant, to improve screening efficiency, rapid antigen tests (RATs) were first added as a supplementary detection method in China in mid-March, 2022. What and how big a role RATs should play need to be supported by clinical data. Here, RAT performance and relevant factors in comparison with nucleic acid amplification tests (NAATs) were assessed in Omicron-infected inpatients. From the NAAT results, nasopharyngeal swabs (NPs) performed better than oropharyngeal swabs (OPs). RATs tested on NAAT positive NPs performed better than those with OP-positive samples. The RAT positivity rate was strongly associated with high levels of N and OFR1ab genes, especially in NPs where patients also had significantly longer hospital stays and shorter days from symptom onset to RAT testing. Self-performed RATs had a detection accuracy that was comparable to professionally performed RATs when the subjects were well guided. The antigen negative rate of the studied patients was 100% at discharge. These findings suggest that, in addition to a supplementary detection role, RATs can be an important strategy for evaluating the disease progression of Omicron-infected inpatients. This study provides important clinical data to support better rules regarding RATs under China's COVID-19 prevention and control policy.
- SARS-CoV-2 Omicron variant
- , Rapid antigen tests (RATs)
- , Dynamic zero-COVID policy
- , COVID-19 progression evaluation

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Electronic Supplementary Material

10.1016j.virs.2022.08.008-ESM.docx