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

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

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
Available online: 29 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

Electronic Supplementary Material

10.1016j.virs.2022.08.008-ESM.docx
References
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Clinical practice of rapid antigen tests for SARS-CoV-2 Omicron variant: A single-center study in China

Corresponding author: Bo Shen, shenb@enzemed.com

Corresponding author: Dongqing Lv, lvdq@enzemed.com

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

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.

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

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