Abstract The outbreak of the novel coronavirus disease (COVID‐19) quickly spread all over China and to more than 20 other countries. Although the virus (severe acute respiratory syndrome coronavirus [SARS‐Cov‐2]) nucleic acid real‐time polymerase chain reaction (PCR) test has become the standard method for diagnosis of SARS‐CoV‐2 infection, these real‐time PCR test kits have many limitations. In addition, high false‐negative rates were reported. There is an urgent need for an accurate and rapid test method to quickly identify a large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. We have developed a rapid and simple point‐of‐care lateral flow immunoassay that can detect immunoglobulin M (IgM) and IgG antibodies simultaneously against SARS‐CoV‐2 virus in human blood within 15 minutes which can detect patients at different infection stages. With this test kit, we carried out clinical studies to validate its clinical efficacy uses. The clinical detection sensitivity and specificity of this test were measured using blood samples collected from 397 PCR confirmed COVID‐19 patients and 128 negative patients at eight different clinical sites. The overall testing sensitivity was 88.66% and specificity was 90.63%. In addition, we evaluated clinical diagnosis results obtained from different types of venous and fingerstick blood samples. The results indicated great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. The IgM‐IgG combined assay has better utility and sensitivity compared with a single IgM or IgG test. It can be used for the rapid screening of SARS‐CoV‐2 carriers, symptomatic or asymptomatic, in hospitals, clinics, and test laboratories.
【저자키워드】 COVID‐19, lateral flow immunoassay, fingerstick blood, point‐of‐care testing, rapid IgM‐IgG combined test, SARS‐CoV‐2 virus infection, 【초록키워드】 Treatment, coronavirus disease, IgM, coronavirus, Infection, Diagnosis, Asymptomatic carrier, virus transmission, novel coronavirus disease, severe acute respiratory syndrome Coronavirus, virus, Novel coronavirus, clinics, hospitals, COVID‐19, SARS‐CoV‐2, Spread, China, polymerase chain reaction, lateral flow immunoassay, nucleic acid, serum, sensitivity, specificity, IgG antibody, PCR, Asymptomatic, Rapid test, Immunoglobulin, IgG antibodies, outbreak, symptomatic, fingerstick blood, Patient, Asymptomatic carriers, Clinical studies, plasma, respiratory, utility, Clinical diagnosis, patients, Blood, clinical study, Clinical efficacy, Detection sensitivity, immunoglobulin M, Chain Reaction, venous blood, negative patients, IgG test, acute respiratory syndrome, acute respiratory syndrome coronavirus, infected patients, stages, Blood samples, carriers, blood sample, SARS‐CoV‐2 infection, SARS‐CoV‐2 virus, nucleic acid real‐time polymerase chain reaction, serum and plasma, point‐of‐care, limitations, Prevent, venous, polymerase chain, identify, detect, collected, carried, reported, indicated, addition, evaluated, eight, can be used, number of infected, were measured, COVID‐19 patient, real‐time PCR test, 【제목키워드】 Diagnosis, Antibody test, development,