Development and clinical application of a rapid IgM‐IgG combined antibody test for SARS‐CoV‐2 infection diagnosis
By Zhengtu Li, Yongxiang Yi, Xiaomei Luo, N. Xiong, Yang Liu, Shaoqiang Li, Ruilin Sun, Yanqun Wang, Bicheng Hu, Wei Chen and 14 more. Journal of Medical Virology, 2020
1,603 citations recorded by the source corpus.
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.
Subfields: Infectious Diseases
View Paper: https://www.semanticscholar.org/paper/823b742d0bdcc097b9cebb97565c2ed7379854d4
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In Infectious Diseases
Citations in the corpus
- Deployment of convalescent plasma for the prevention and treatment of COVID-19. (2020, neutral): “Another group reported on performance of a point-of-care antibody test for combined detection of IgM and IgG, demonstrating a sensitivity and specificity of 88.7% and 90.6%, respectively (29).”
- Modelling the COVID-19 epidemic and implementation of population-wide interventions in Italy (2020, background): “Some laboratories are actually moving in this direction by developing a 15 minutes test to detect SARS-CoV-2 IgM and IgG simultaneously in human blood [33].”
- COVID-19 and diabetes: Knowledge in progress (2020, neutral): “[24] Li Z, Yi Y, Luo X, Xiong N, Liu Y, Li S, et al.”
- Detection of COVID-19 Infection from Routine Blood Exams with Machine Learning: A Feasibility Study (2020, background): “The large demand for rRT-PCR tests (also commonly known as nasopharyngeal swab tests) due to the worldwide extension of the virus is highlighting the limitations of this type of diagnosis on a large-scale such as: the long turnaround times (on average over 2 to 3 hours to generate results); the need”
- Psychological Impact and Coping Strategies of Frontline Medical Staff in Hunan Between January and March 2020 During the Outbreak of Coronavirus Disease 2019 (COVID-19) in Hubei, China (2020, background): “have recently reported that both anti-virus IgM and IgG could be used for confirmed diagnosis when molecular testing is negative [21] .”
- Laboratory Diagnosis of COVID-19: Current Issues and Challenges (2020, background): “As mentioned above, rapid lateral flow assays for antibodies (IgM and IgG) produced during COVID-19 have been developed (70).”