Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG.
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Shen Bo, Zheng Yufen, Zhang Xiaoyan, Zhang Weituo, Wang Donglian, Jin Jie, Lin Rong, Zhang Ying, Zhu Guangjun, Zhu Hongguo, Li Jun, Xu Jiaqin, Ding Xianhong, Chen Shiyong, Lu Ruyue, He Zebao, Zhao Haihong, Ying Lingjun, Zhang Chao, Lv Dongqing, Chen Baofu, Chen Jiya, Zhu Jiansheng, Hu Bingjie, Hong Chenliang, Xu Xiangyu, Chen Jiaxi, Liu Chong, Zhou Kai, Li Jing, Zhao Guoling, Shen Weixiang, Chen Chunfeng, Shao Chunyan, Shen Xiaoying, Song Jingjing, Wang Zhipeng, Meng Ying, Wang Chao, Han Junsong, Chen Aojun, Lu Daru, Qian Biyun, Chen Haixiao, Gao Hengjun
Аннотация
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.