The results indicated great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. In addition, we evaluated clinical diagnosis results obtained from different types of venous and fingerstick blood samples. The overall testing sensitivity was 88.66% and specificity was 90.63%. 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 8 different clinical sites. With this test kit, we carried out clinical studies to validate its clinical efficacy uses. We have developed a rapid and simple point‐of‐care lateral flow immunoassay which can detect IgM and IgG antibodies simultaneously against SARS‐CoV‐2 virus in human blood within 15 minutes which can detect patients at different infection stages. There is an urgent need for an accurate and rapid test method to quickly identify large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. In addition, high false negative rates were reported. Although the virus (SARS‐Cov‐2) nucleic acid RT‐PCR test has become the standard method for diagnosis of SARS‐CoV‐2 infection, these real‐time PCR test kits have many limitations. The outbreak of the novel coronavirus disease (COVID‐19) quickly spread all over China and to more than 20 other countries.
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