Development and Clinical Application of A Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 Infection Diagnosis

Journal of Medical Virology
Zhengtu LiFeng Ye

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 (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. In addition, high false negative rates were reported. 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. 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. 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 8 different clinical sites. The overall testing sensitivity was 88.66% and specificity was 90.63%. In addition, we evaluated clinical diagnosis results obtained...Continue Reading

Associated Clinical Trials

References

Apr 12, 2003·The New England Journal of Medicine·Thomas G KsiazekUNKNOWN SARS Working Group
Jun 23, 2009·Immunology Letters·Rachael Racine, Gary M Winslow
Oct 19, 2012·The New England Journal of Medicine·Ali M ZakiRon A M Fouchier
Feb 4, 2014·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Chen WangLanjuan Li
Apr 4, 2015·The American Journal of Emergency Medicine·Adam J SingerHenry C Thode
Jan 25, 2020·The New England Journal of Medicine·Na ZhuUNKNOWN China Novel Coronavirus Investigating and Research Team
Feb 1, 2020·The New England Journal of Medicine·Camilla RotheMichael Hoelscher
Feb 8, 2020·Military Medical Research·Ying-Hui JinUNKNOWN , for the Zhongnan Hospital of Wuhan University Novel Coronavirus Management and Research Team, Evidence-Based Medicine Chap
Feb 13, 2020·Euro Surveillance : Bulletin Européen Sur Les Maladies Transmissibles = European Communicable Disease Bulletin·Jantien A BackerJacco Wallinga
Feb 20, 2020·The New England Journal of Medicine·Lirong ZouJie Wu
Apr 7, 2020·Infection Control and Hospital Epidemiology : the Official Journal of the Society of Hospital Epidemiologists of America·Peisheng XiongGuang Xiao

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Citations

Mar 21, 2020·Allergy·Xiang DongYa-Dong Gao
Apr 29, 2020·Journal of Primary Care & Community Health·Zach Sartor, Burritt Hess
Apr 1, 2020·Journal of Medical Virology·Irene CassanitiUNKNOWN Members of the San Matteo Pavia COVID-19 Task Force
Apr 23, 2020·Journal of Cellular and Molecular Medicine·Hua LiJunbo Ge
May 5, 2020·Hemodialysis International·Pasquale EspositoFrancesca Viazzi
May 14, 2020·Diagnostics·Amanda MoyanoM Carmen Blanco-López
May 23, 2020·Diagnostics·Panagiota I KontouPantelis G Bagos
May 30, 2020·International Journal of Environmental Research and Public Health·Fei ZhaiJiankun Liang
May 18, 2020·Science·Florian Krammer, Viviana Simon
May 30, 2020·Journal of Medical Virology·Tao LiuXinghuan Wang
May 30, 2020·Viruses·Nadin YounesGheyath K Nasrallah
Jun 26, 2020·The Cochrane Database of Systematic Reviews·Jonathan J DeeksUNKNOWN Cochrane COVID-19 Diagnostic Test Accuracy Group
Jun 13, 2020·Expert Review of Respiratory Medicine·Arafat HussainAnant Mohan
May 30, 2020·Cellular & Molecular Immunology·Huan MaTengchuan Jin
Jul 2, 2020·Journal of Clinical Medicine·Francesco SessaCristoforo Pomara
Jul 10, 2020·Journal of Clinical Apheresis·Tuğçe Nur YiğenoğluFevzi Altuntaş
Jul 16, 2020·The Korean Journal of Internal Medicine·Jihyang Lim, Jehoon Lee
Jun 11, 2020·Journal of Clinical Microbiology·Sarah DellièreUNKNOWN Saint-Louis CORE (COvid REsearch) group
Jun 9, 2020·Clinical and Translational Medicine·Hua LiJunbo Ge
Jul 30, 2020·Acta Clinica Belgica·Jiajia QuYuwen Xue
Jul 16, 2020·Revista do Colégio Brasileiro de Cirurgiões·Neeraj Sinha, Galit Balayla
May 29, 2020·Journal of Travel Medicine·Lin H ChenLeo G Visser
May 27, 2020·Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery·Todd SpockRaj Shrivastava
Apr 18, 2020·Clinical Chemistry and Laboratory Medicine : CCLM·Davide FerrariMassimo Locatelli
Mar 20, 2020·Clinical Chemistry and Laboratory Medicine : CCLM·Giuseppe Lippi, Mario Plebani
May 15, 2020·Clinical Chemistry and Laboratory Medicine : CCLM·Job Harenberg, Emmanuel Favaloro
Sep 5, 2020·European Journal of Clinical Microbiology & Infectious Diseases : Official Publication of the European Society of Clinical Microbiology·Oktavija Đaković RodeAlemka Markotić
Aug 5, 2020·The Journal of Applied Laboratory Medicine·Thessicar Antoine-ReidJonathan E Schmitz
Jul 7, 2020·Clinical Chemistry and Laboratory Medicine : CCLM·Bram DecruPieter Vermeersch
Apr 4, 2020·Journal of Medical Virology·Zhe DuTianbing Wang
May 23, 2020·Postgraduate Medical Journal·Elizabeth Jane Eggleton
Aug 31, 2020·Immunology and Cell Biology·Sarfaraz Ahmad EjaziNahid Ali
Apr 10, 2020·BMJ : British Medical Journal·Nick J BeechingMike B J Beadsworth
Jul 10, 2020·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Zhengtu LiFeng Ye

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BETA
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