Development and Head-to-Head Comparison of Two Colloidal Gold Based Serologic Lateral Flow Assays for SARS-CoV-2 Antibody Tests

Jing Tian, Wang Kan, Liu Yanlei, Liang Hui, Li Xueling, Cui Daxiang

Abstract

To combat the COVID-19 pandemic, serologic lateral flow immunoassays are required to facilitate accurate diagnosis of SARS-CoV-2 infection and confirmation of molecular results. This study evaluated sensitivity of two different designs of colloidal gold serologic tests (antigen based total antibody test and antibody based IgG test) by using residual serum samples from patients who were evaluated for SARS-CoV-2 infection status by polymerase chain reaction (PCR). The results showed 100% specificity for both tests, while when testing of 16 positive patients, the data showed 90% sensitivity for total antibody test and 30% for IgG test. This study demonstrates high diagnostic accuracy for anti-SARS-CoV-2 total antibody tests and will facilitate further development and selection of serological assays.

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Nano Biomedicine and Engineering.

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