Dataset Information

Development and clinical application of a rapid SARS-CoV-2 antibody test strip: A multi-center assessment across China.

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.

SUBMITTER: Liao M

PROVIDER: S-EPMC7645889 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Development and clinical application of a rapid SARS-CoV-2 antibody test strip: A multi-center assessment across China.

Liao Mengting M Yan Jiawei J Wang Xinfeng X Qian Huimin H Wang Chao C Xu Dan D Wang Bin B Yang Bo B Liu Shaohui S Zhou Mao M Gao Qian Q Zhou Qian Q Luo Jiquan J Li Zongxiang Z Liu Wenen W

Journal of clinical laboratory analysis 20201016 1

<h4>Background</h4>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.<h4>Method</h4>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 insti ...[more]

PMID: 33067888

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Project description:The urgent need to scale up testing capacity during the COVID-19 pandemic has prompted the rapid development of point-of-care diagnostic tools such as lateral flow immunoassays (LFIA) for large-scale community-based rapid testing. However, studies of how the general public perform when using LFIA tests in different environmental settings are scarce. This user experience (UX) study of 264 participants in Northern Ireland aimed to gather a better understanding of how self-administered LFIA tests were performed by the general public at home. The UX performance was assessed via analysis of a post-test questionnaire including 30 polar questions and 11 7-point Likert scale questions, which covers the multidimensional aspects of UX in terms of ease of use, effectiveness, efficiency, accuracy and satisfaction. Results show that 96.6% of participants completed the test with an overall average UX score of 95.27% [95% confidence interval (CI) 92.71-97.83%], which suggests a good degree of user experience and effectiveness. Efficiency was assessed based on the use of physical resources and human support received, together with the mental effort of self-administering the test measured via NASA Task Load Index (TLX). The results for six TLX subscales show that the participants scored the test highest for mental demand and lowest for physical demand, but the average TLX score suggests that the general public have a relatively low level of mental workload when using LFIA self-testing at home. Five printed LFIA testing results (i.e. the 'simulated' results) were used as the ground truth to assess the participant's performance in interpreting the test results. The overall agreement (accuracy) was 80.63% [95% CI 75.21-86.05%] with a Kappa score 0.67 [95% CI 0.58-0.75] indicating substantial agreement. The users scored lower in confidence when interpreting test results that were weak positive cases (due to the relatively low signal intensity in the test-line) compared to strong positive cases. The end-users also found that the kit was easier to use than they expected (p < 0.001) and 231 of 264 (87.5%) reported that the test kit would meet their requirements if they needed an antibody testing kit. The overall findings provide an insight into the opportunities for improving the design of self-administered SARS-CoV-2 antibody testing kits for the general public and to inform protocols for future UX studies of LFIA rapid test kits.

Project description:IntroductionSwine acute diarrhea syndrome coronavirus (SADS-CoV) is an enveloped, positive-sense, single-stranded RNA virus that causes clinical symptoms such as vomiting and diarrhea in 10-day-old piglets. SADS-CoV has caused significant economic losses in the swine industry in southern China. Currently, no effective treatments or vaccines are available for this disease, making it crucial to establish a point-of-care testing (POCT) technology for early diagnosis and prevention.MethodsIn this study, we first validated the specificity and immunogenicity of four monoclonal antibodies (mAbs) targeting the nucleocapsid (N) protein of swine acute diarrhea syndrome coronavirus (SADS-CoV). The optimal antibody pair for constructing the fluorescent microsphere-based immunochromatographic assay (FM-ICA) was determined through systematic pairwise screening. Critical parameters of the FM-ICA test strip, including antibody labeling concentration, coating concentration, incubation time, and sample dilution ratio, were subsequently optimized. Analytical performance characteristics of the developed FM-ICA were then rigorously evaluated. Finally, clinical validation was conducted by parallel testing of 72 field samples using both FM-ICA and quantitative PCR (qPCR), followed by concordance rate analysis.ResultsFirst, we demonstrated that all four monoclonal antibodies exhibited favorable immunogenicity and specificity. Subsequently, mAb 12E1 was identified as the coating antibody, and mAb 5G12 was selected as the labeled antibody, forming the optimal combination for FM-ICA preparation. After optimization, the ideal parameters were determined: a labeling concentration of 200 μg/mg for antibodies, a coating concentration of 1 mg/mL, an incubation time of 10 min, and a dilution factor of 10. The FM-ICA exhibited outstanding specificity, sensitivity, reproducibility, and stability, achieving a maximum detectable dilution factor of 1280 and a limit of detection (LOD) of 78 PFU mL⁻¹. Finally, the concordance rate between FM-ICA and qPCR for clinical samples reached 97.22%.DiscussionThese results indicate that FM-ICA is an excellent POCT technology that can be used for the early diagnosis of SADS-CoV, providing support for disease prevention and treatment.

Dataset Information

Development and clinical application of a rapid SARS-CoV-2 antibody test strip: A multi-center assessment across China.

Background

Method

Results

Conclusion

Publications

Development and clinical application of a rapid SARS-CoV-2 antibody test strip: A multi-center assessment across China.

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