Time course of the sensitivity and specificity of anti-SARS-CoV-2 IgM and IgG antibodies for symptomatic COVID-19 in Japan

被引:48
作者
Nakano, Yuki [1 ]
Kurano, Makoto [1 ,2 ]
Morita, Yoshifumi [1 ]
Shimura, Takuya [1 ]
Yokoyama, Rin [1 ]
Qian, Chungen [3 ]
Xia, Fuzhen [4 ]
He, Fan [4 ]
Kishi, Yoshiro [5 ]
Okada, Jun [5 ]
Yoshikawa, Naoyuki [1 ]
Nagura, Yutaka [6 ]
Okazaki, Hitoshi [6 ]
Moriya, Kyoji [7 ]
Seto, Yasuyuki [8 ]
Kodama, Tatsuhiko [9 ]
Yatomi, Yutaka [1 ,2 ]
机构
[1] Univ Tokyo Hosp, Dept Clin Lab, Tokyo, Japan
[2] Univ Tokyo, Grad Sch Med, Dept Clin Lab Med, Bunkyo Ku, 7-3-1 Hongo, Tokyo 1138655, Japan
[3] Huazhong Univ Sci & Technol, Dept Biomed Engn,Key Lab Biomed Photon MOE, Coll Life Sci & Technol,Wuhan Natl Lab Optoelect, Hubei Bioinformat & Mol Imaging Key Lab,Syst Biol, Wuhan, Hubei, Peoples R China
[4] Shenzhen YHLO Biotech Co Ltd, Reagent R&D Ctr, Shenzhen, Guangdong, Peoples R China
[5] Med & Biol Labs Co Ltd, Sales & Mkt Div, Business Planning Dept, Tokyo, Japan
[6] Univ Tokyo Hosp, Dept Blood Transfus, Tokyo, Japan
[7] Univ Tokyo, Dept Infect Control & Prevent, Tokyo, Japan
[8] Univ Tokyo, Dept Gastrointestinal Surg, Tokyo, Japan
[9] Univ Tokyo, Lab Syst Biol & Med, Tokyo, Japan
关键词
D O I
10.1038/s41598-021-82428-5
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
The accurate and prompt diagnosis of SARS-CoV-2 infection is required for the control and treatment of the coronavirus infection disease 2019 (COVID-19). In this study, we aimed to investigate the time courses of the anti-severe acute corona respiratory syndrome coronavirus 2 (SARS-CoV-2) IgM and IgG titers and to evaluate the sensitivity and specificity of such tests according to the specific day after the onset of COVID-19 among a patient population in Japan. We measured the titers of SARS-CoV-2 IgM and IgG in sera from 105 subjects, including 26 symptomatic COVID-19 patients, using chemiluminescent immunoassay (CLIA) methods utilizing magnetic beads coated with SARS-CoV-2 nucleocapsid protein and spike protein. The results of a ROC analysis suggested the possibility that the cutoff values in Japan might be lower than the manufacturer's reported cutoff (10 AU/mL): 1 AU/mL for IgM and 5 AU/mL for IgG. The sensitivity of the test before Day 8 after symptom onset was less than 50%; at Days 9-10, however, we obtained a much higher sensitivity of 81.8% for both IgM and IgG. At 15 days or later after symptom onset, the SARS-CoV-2 IgG test had a sensitivity of 100%. These results suggest that if the number of days since disease onset is taken into consideration, these antibody tests could be very useful for the diagnosis of COVID-19 and similar diseases.
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页数:10
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