Development and clinical application of a rapid SARS‐CoV‐2 antibody test strip: A multi‐center assessment across China. Issue 1 (16th October 2020)

• Record Type: Journal Article
• Authors: Liao, Mengting; Yan, Jiawei; Wang, Xinfeng; Qian, Huimin; Wang, Chao; Xu, Dan; Wang, Bin; Yang, Bo; Liu, Shaohui; Zhou, Mao; Gao, Qian; Zhou, Qian; Luo, Jiquan; Li, Zongxiang; Liu, Wenen
• Is Part Of: Journal of clinical laboratory analysis. Volume 35:Issue 1(2021)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2020-10-16
• Subjects: colloidal gold immunochromatography assay -- COVID‐19 -- multi‐center assessment -- performance evaluation -- SARS‐CoV‐2 -- serological test; Diagnosis, Laboratory -- Periodicals; Medical laboratory technology -- Periodicals; 616
• DOI: 10.1002/jcla.23619
• Languages: English
• ISSNs: 0887-8013

Abstract

Abstract: Background: The ongoing coronavirus disease 19 (COVID‐19) is posing a threat to the public health globally. Serological test for SARS‐CoV‐2 antibody can improve early diagnosis of COVID‐19 and serves as a valuable supplement to RNA detection. Method: A SARS‐CoV‐2 IgG/IgM combined antibody test strip based on colloidal gold immunochromatography assay was developed, with both spike protein and nucleocapsid protein of SARS‐CoV‐2 antigen used for antibody detection. From 3 medical institutions across China, serum or plasma of 170 patients with confirmed COVID‐19 diagnosis and 300 normal controls were collected and tested with the strip. Sensitivity, specificity, kappa coefficient, receiver operating characteristic (ROC) curve, and area under the curve (AUC) were analyzed. Positive rates in different medical centers, age group, gender, and different disease course were compared. Results: 158 out 170 samples from confirmed COVID‐19 patients had positive results from the test, and 296 out of 300 samples from normal controls had negative results. The kit was 92.9% sensitive and 98.7% specific. The positive rate was 77.3% during the first week after disease onset, but reached 100% since day 9. AUC and kappa coefficient were 0.958 and 0.926, respectively, which showed the consistency of the test results with the standard diagnosis. Age or gender caused little variations in the kit sensitivity. Conclusion: The rapid, easy‐to‐use SARS‐CoV‐2 IgG/IgM combined antibody test kit has a superior performance, which can help with accurate diagnosis and thus timely treatment and isolation of COVID‐19 patients, that contributes to the better control of the global pandemic. Abstract : A SARS‐CoV‐2 IgG/IgM combined antibody test strip based on immunochromatography assay was developed with both spike protein and nucleocapsid protein used for detection. With clinical assessment from 3 medical centers from across China, the kit was 92.9% sensitive and 98.7% specific. The positive rate was 77.3% during the first week after disease onset and reached 100% since day 9.