Development and Clinical Evaluation of a Rapid Antibody Lateral Flow Assay for the Diagnosis of SARS-CoV-2 Infection [post]

Kesheng Li, Chongxiang Tong, Xiaoqin Ha, Chaoning Zeng, Xia Chen, Feifei Xu, Jinhong Yang, Huifen Du, Yuxin Chen, Jing Cai, Zengwei Yang, Zhongyi Jiang (+5 others)
2020 unpublished
Background: The novel coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which has quickly spread worldwide since its outbreak in December 2019. One of the primary measures for controlling the spread of SARS-CoV-2 infection is an accurate assay for its diagnosis. SARS-CoV-2 real-time PCR kits suffer from some limitations, including false-negative results in the clinic. Therefore, there is an urgent need for the
more » ... ent need for the development of a rapid antibody test kit for COVID-19 diagnosis.Methods: The nuclear capsid protein (N) and spike protein 1 (S1) fragments of SARS-CoV-2 were expressed in Escherichia coli, and rapid antibody-based tests for the diagnosis of SARS-CoV-2 infection were developed and compared. To evaluate their clinical applications, the serum from COVID-19 patients, suspected COVID-19 patients, recovering COVID-19 patients, patients with general fever or pulmonary infection, doctors and nurses who worked at the fever clinic, and health professionals was analyzed by the rapid antibody test kits. The serum from patients infected with Mycoplasma pneumoniae and patients with respiratory tract infection was further analyzed to test its cross-reactivity with other respiratory pathogens.Results: A 47 kDa N protein and 67 kDa S1 fragment of SARS-CoV-2 were successfully expressed, purified, and renatured. The rapid antibody test with recombinant N protein showed higher sensitivity and specificity than the rapid IgM antibody test with recombinant S1 protein. Clinical evaluation showed that the rapid antibody test kit with recombinant N protein had 88.56% sensitivity and 97.42% specificity for COVID-19 patients, 53.48% positive rate for suspected COVID-19 patients, 57.14% positive rate for recovering COVID-19 patients, and 3.20%-3.27% cross-reactivity with other respiratory pathogens. The sensitivity of the kit did not significantly differ in COVID-19 patients with different disease courses (p < 0.01).Conclusion: The rapid antibody test kit with recombinant N protein has high specificity and sensitivity, and can be used for the diagnosis of SARS-CoV-2 infection combined with RT-PCR.
doi:10.21203/rs.3.rs-94508/v1 fatcat:72hjyqvdjjgh7htj2flvfbkzui