Application of sars-cov-2 antibody sample panel in quality evaluation of test cassettes for colloidal gold lateral flow assay

Document Type

Article

Publication Date

1-1-2021

Abstract

Objective To establish a SARS-CoV-2 antibody sample panel and apply to the quality evaluation of test cassettes for colloidal gold lateral flow assay. Methods SARS-CoV-2 antibody sample panel was established with the convalescent plasma samples from patients with Corona Virus Disease 2019 (COVID-19) and optimized. Suggestions for modification were put forward on the sample panels from three manufacturers (S, L and H), and the test cassettes after modification were analyzed and compared. Results The accuracy, sensitivity, specificity and Youden index of cassette from manufacturer S were 92. 54%, 90. 78%, 100% and 0. 908 respectively, while the positive test region was light in color and not easy to be recognized. However, after modification, the accuracy, sensitivity, specificity and Youden index were 95. 35%, 98. 91%, 97. 19% and 0. 943 respectively, while the color of positive test region was developed obviously and easy to be recognized. The sensitivity of cassette from manufacturer L was only 14. 28% before modification, while the positive test region was unobvious in color, indicating a high missed detection rate. However, after modification, the sensitivity for IgM was 98. 63% , while the color of positive test region was developed obviously and rapidly. The sensitivity, specificity, accuracy and Youden index were 98. 08%, 100. 00%, 98. 90% and 0. 981 for IgG, while were 84. 50%, 86. 49%, 85. 71% and 0. 710 for IgM, respectively. Conclusion The developed sample panel may be used for the quality evaluation of SARS-CoV-2 antiobdy detection reagents.

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