Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG

Bo Shen; Yufen Zheng; Xiaoyan Zhang; Weituo Zhang; Donglian Wang; Jie Jin; Rong Lin; Ying Zhang; Guangjun Zhu; Hongguo Zhu; Jun Li; Jiaqin Xu; Xianhong Ding; Shiyong Chen; Ruyue Lu; Zebao He; Haihong Zhao; Lingjun Ying; Chao Zhang; Dongqing Lv; Baofu Chen; Jiya Chen; Jiansheng Zhu; Bingjie Hu; Chenliang Hong; Xiangyu Xu; Jiaxi Chen; Chong Liu; Kai Zhou; Jing Li; Guoling Zhao; Weixiang Shen; Chunfeng Chen; Chunyan Shao; Xiaoying Shen; Jingjing Song; Zhipeng Wang; Ying Meng; Chao Wang; Junsong Han; Aojun Chen; Daru Lu; Biyun Qian; Haixiao Chen; Hengjun Gao

Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG

Am J Transl Res. 2020 Apr 15;12(4):1348-1354. eCollection 2020.

Authors

Bo Shen¹, Yufen Zheng¹, Xiaoyan Zhang^{2

3

4}, Weituo Zhang⁵, Donglian Wang¹, Jie Jin^{3

6}, Rong Lin⁷, Ying Zhang¹, Guangjun Zhu¹, Hongguo Zhu¹, Jun Li¹, Jiaqin Xu¹, Xianhong Ding¹, Shiyong Chen¹, Ruyue Lu¹, Zebao He¹, Haihong Zhao¹, Lingjun Ying¹, Chao Zhang¹, Dongqing Lv¹, Baofu Chen¹, Jiya Chen¹, Jiansheng Zhu¹, Bingjie Hu¹, Chenliang Hong¹, Xiangyu Xu¹, Jiaxi Chen¹, Chong Liu¹, Kai Zhou¹, Jing Li^{3

6}, Guoling Zhao^{3

6}, Weixiang Shen^{2

3

6}, Chunfeng Chen^{3

6}, Chunyan Shao^{3

6}, Xiaoying Shen^{3

6}, Jingjing Song^{3

6}, Zhipeng Wang^{3

6}, Ying Meng^{3

6}, Chao Wang^{3

6}, Junsong Han^{3

6}, Aojun Chen^{3

8}, Daru Lu⁴, Biyun Qian⁵, Haixiao Chen¹, Hengjun Gao^{2

3}

Affiliations

¹ Taizhou Hospital, Wenzhou Medical University Linhai 317000, China.
² Institute of Digestive Diseases, School of Medicine, Tongji University, Tongji Hospital Affiliated to Tongji University Shanghai 200065, China.
³ National Engineering Center for Biochip at Shanghai Shanghai 201203, China.
⁴ State Key Laboratory of Genetic Engineering, School of Life Sciences, Fudan University Shanghai 200433, China.
⁵ Hongqiao International Institute of Medicine, Shanghai Tongren Hospital and Clinical Research Institute, Shanghai Jiao Tong University School of Medicine Shanghai 200025, China.
⁶ Shanghai Engineering Technology Center for Molecular Medicine Shanghai 201023, China.
⁷ Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan 430022, China.
⁸ China Center of Molecular Medicine for Helicobacter Pylori Shanghai 201321, China.

PMID: 32355546
PMCID: PMC7191168

Abstract

Background: Since December 2019, there had been an outbreak of COVID-19 in Wuhan, China. At present, diagnosis COVID-19 were based on real-time RT-PCR, which have to be performed in biosafe laboratory and is unsatisfactory for suspect case screening. Therefore, there is an urgent need for rapid diagnostic test for COVID-19.

Objective: To evaluate the diagnostic performance and clinical utility of the colloidal gold immunochromatography assay for SARS-Cov-2 specific IgM/IgG anti-body detection in suspected COVID-19 cases.

Methods: In the prospective cohort, 150 patients with fever or respiratory symptoms were enrolled in Taizhou Public Health Medical Center, Taizhou Hospital, Zhejiang province, China, between January 20 to February 2, 2020. All patients were tested by the colloidal gold immunochromatography assay for COVID-19. At least two samples of each patient were collected for RT-PCR assay analysis, and the PCR results were performed as the reference standard of diagnosis. Meanwhile 26 heathy blood donor were recruited. The sensitivity and specificity of the immunochromatography assay test were evaluated. Subgroup analysis were performed with respect to age, sex, period from symptom onset and clinical severity.

Results: The immunochromatography assay test had 69 positive result in the 97 PCR-positive cases, achieving sensitivity 71.1% [95% CI 0.609-0.797], and had 2 positive result in the 53 PCR-negative cases, achieving specificity 96.2% [95% CI 0.859-0.993]. In 26 healthy donor blood samples, the immunochromatography assay had 0 positive result. In subgroup analysis, the sensitivity was significantly higher in patients with symptoms more than 14 days 95.2% [95% CI 0.741-0.998] and patients with severe clinical condition 86.0% [95% CI 0.640-0.970].

Conclusions: The colloidal gold immunochromatography assay for SARS-Cov-2 specific IgM/IgG anti-body had 71.1% sensitivity and 96.2% specificity in this population, showing the potential for a useful rapid diagnosis test for COVID-19. Further investigations should be done to evaluate this assay in variety of clinical settings and populations.

Keywords: COVID-19; immunoglobulin M/immunoglobulin G; rapid diagnosis.