Analytical and clinical validation of an ELISA for specific SARS-CoV-2 IgG, IgA, and IgM antibodies

被引:77
作者
Tre-Hardy, Marie [1 ,2 ,3 ]
Wilmet, Alain [1 ]
Beukinga, Ingrid [1 ]
Favresse, Julien [4 ]
Dogne, Jean-Michel [3 ]
Douxfils, Jonathan [3 ,5 ]
Blairon, Laurent [1 ]
机构
[1] Iris Hosp South, Dept Lab Med, Rue Jean Paquot 63, B-1050 Brussels, Belgium
[2] Univ Libre Bruxelles, Fac Med, Brussels, Belgium
[3] Univ Namur, Namur Res Inst LIfe Sci, Dept Pharm, Namur, Belgium
[4] Clin St Luc Bouge, Dept Lab Med, Namur, Belgium
[5] Qualiblood Sa, Namur, Belgium
关键词
antibodies; COVID-19; ELISA; IgA; IgG; IgM; kinetics; SARS-CoV-2; ASSAY;
D O I
10.1002/jmv.26303
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
The development of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests is massive. The external validation of their performance is needed before use in clinical routine practice. Our study aims at assessing the analytical and clinical performance of two enzyme-linked immunosorbent assay tests detecting antibodies directed against the virus nucleocapsid protein: The NovaLisa SARS-CoV-2 immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM) test (NovaTec) allowing a separate detection of each antibody and the Platelia SARS-CoV-2 Total Ab test (Bio-Rad) detecting total antibodies (IgM, IgA, and IgG). Two-hundred and eight coronavirus disease 2019 samples from 48 quantitative reverse transcription-polymerase chain reaction (RT-qPCR) confirmed patients were used to perform the sensitivity analysis. Non-SARS-CoV-2 sera (n = 79) with a potential cross-reaction to SARS-CoV-2 immunoassays were included in the specificity analysis. In addition, using receiver operator characteristic curves, adapted cut-off for improvement of the performances were proposed. The kinetics of these antibodies was also assessed over 8 weeks. Two weeks after the RT-qPCR positive detection, the NovaLisa test shows a sensitivity and specificity of 94.9% (95% confidence interval [CI]: 83.1%-98.6%) and 96.2% (95% CI: 89.4%-98.7%) for IgG, of 89.7% (95% CI: 76.4%-95.9%) and 98.7% (95% CI: 93.2%-98.8%) for IgA, and of 48.7% (95% CI: 33.9%-63.8%) and 98.7% (95% CI: 93.2%-99.8%) for IgM. With the Platelia system, the specificity and sensitivity were 97.4% (95% CI: 92.1%-99.7%) and 94.9% (95% CI: 87.7%-98.0%) for total antibodies using the adapted cut-offs. The NovaLisa and the Platelia tests have satisfactory analytical performances. The clinical performances are excellent for IgG, IgA, and total antibodies especially if the cut-off is optimized.
引用
收藏
页码:803 / 811
页数:9
相关论文
共 24 条
  • [1] Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies
    Beavis, Kathleen G.
    Matushek, Scott M.
    Abeleda, Ana Precy F.
    Bethel, Cindy
    Hunt, Carlissa
    Gillen, Stephanie
    Moran, Angelica
    Tesic, Vera
    [J]. JOURNAL OF CLINICAL VIROLOGY, 2020, 129
  • [2] Carey N.R., 2014, USER VERIFICATION PR, Vthird
  • [3] A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster
    Chan, Jasper Fuk-Woo
    Yuan, Shuofeng
    Kok, Kin-Hang
    To, Kelvin Kai-Wang
    Chu, Hin
    Yang, Jin
    Xing, Fanfan
    Liu, Jieling
    Yip, Cyril Chik-Yan
    Poon, Rosana Wing-Shan
    Tsoi, Hoi-Wah
    Lo, Simon Kam-Fai
    Chan, Kwok-Hung
    Poon, Vincent Kwok-Man
    Chan, Wan-Mui
    Ip, Jonathan Daniel
    Cai, Jian-Piao
    Cheng, Vincent Chi-Chung
    Chen, Honglin
    Hui, Christopher Kim-Ming
    Yuen, Kwok-Yung
    [J]. LANCET, 2020, 395 (10223) : 514 - 523
  • [4] COFRAC, GUID TECHN ACCR VER
  • [5] Dunya Saglik Orgutu, 2020, NAMING CORONAVIRUS D
  • [6] Clinical Performance of the Elecsys Electrochemiluminescent Immunoassay for the Detection of SARS-CoV-2 Total Antibodies
    Favresse, Julien
    Eucher, Christine
    Elsen, Marc
    Tre-Hardy, Marie
    Dogne, Jean-Michel
    Douxfils, Jonathan
    [J]. CLINICAL CHEMISTRY, 2020, 66 (08) : 1104 - 1106
  • [7] FindDx.org, SARS COV 2 DIAGN PIP
  • [8] GeurtsvanKessel CH, 2020, INFECT DIS EXCEPT HI, DOI [10.1101/2020.04.23.20077156, DOI 10.1101/2020.04.23.20077156]
  • [9] Evaluation of commercial and automated SARS-CoV-2 IgG and IgA ELISAs using coronavirus disease (COVID-19) patient samples
    Jaaskelainen, Anne J.
    Kekalainen, Eliisa
    Kallio-Kokko, Hannimari
    Mannonen, Laura
    Kortela, Elisa
    Vapalahti, Olli
    Kurkela, Satu
    Lappalainen, Maija
    [J]. EUROSURVEILLANCE, 2020, 25 (18): : 11 - 18
  • [10] Neutralizing Antibodies against SARS-CoV-2 and Other Human Coronaviruses
    Jiang, Shibo
    Hillyer, Christopher
    Du, Lanying
    [J]. TRENDS IN IMMUNOLOGY, 2020, 41 (05) : 355 - 359