Reliability of antibody tests for COVID-19 diagnosis

Year 2023, , 93 - 98, 31.01.2023

Nilay Coplu Cetin Kılınc Aysegul Gozalan Busra Calısır Cemile Sonmez Mustafa Muhammet Gul Zeynep Aygun Ahlatcıoglu

https://doi.org/10.5472/marumj.1245068

Abstract

Objective: The reverse transcription–polymerase chain reaction test (RT-PCR) is the gold standard for the diagnosis of coronavirus
disease 2019 (COVID-19), and antibody tests are useful as supplemental tools for diagnosis, for measuring the population’s immunity
levels, and for checking infection in asymptomatic contacts. This study aimed to evaluate the reliability of five commercial antibody
detection test kits.
Materials and Methods: The reliability of the Colloidal Gold COVID-19 IgG/IgM Rapid Test Kit, Antibody Rapid Test Hotgen,
Beijing Hotgen Biotech Co., Ltd., China), Abbott Chemiluminescent Microparticle Immunoassay (Illinois, USA), Roche
Electrochemiluminescence Immunoassay (Roche Diagnostics, Switzerland), Siemens Chemiluminescence (Munich, Germany), and
Euroimmun ELISA (Lübeck, Germany) for COVID-19 diagnosis was studied. The antibody-negative group included 50 sera from
2018, and the antibody-positive group included 98 patients with positive RT-PCR results from whom blood samples had been collected
3–9 weeks after hospital discharge. Statistical analysis was performed using SPSS version 23.0 (IBM Corporation, Armonk, NY, USA).
The antibody tests’ validity and intra-assay reproducibility were examined, and the Cohen’s kappa coefficients were obtained. The
disease prevalence was pegged at 10%.
Results: The antibody tests’ sensitivity (69.12–72.46%) and positive predictive values (42.44–100.0%) were low, and their specificity
(89.58–100%) and negative predictive values (96.31–97.03%) were high. Their accuracy rates varied from 87.54% to 97.25%, and their
intra-assay coefficients of variation varied from 1% to 10%.
Conclusion: The agreement between the results of the antibody detection test kits was higher when the kits were classified according to
the targeted antigens. The time of blood sample collection, targeted antigens, and antibody types affected the results. Serological tests
were found to be useful, and the commercial kits were found to be largely reliable, although, some parameters need to be improved.

Keywords

COVID-19, Antibody, Validity, Chemiluminescent, Electrochemiluminescence, ELISA

References

• Long OX, Liu, BZ, Deng HJ. et al. Antibody responses to SARSCoV- 2 in patients with COVID-19. Nat Med 2020;26:845-8. doi.org/10.1038/s41591.020.0897-1
• Yongchen Z, Shen H, Wang X , et.al. Different longitudinal patterns of nucleic acid and serology testing results based on disease severity of COVID-19 patients. Emerg Microbes Infect 2020; 9: 833-6. doi: 10.1080/22221.751.2020.1756699
• Tehrani ZR, Saadat S, Saleh E, et.al. Performance of nucleocapsid and spike-based SARS-CoV-2 serologic assays. 2020, Plos One 2020. doi.org/10.1371/journal.pone.0237828
• Rashid Z Z, Othman S N, Abdul Samat M N, Ali U K, Wong K K. Diagnostic performance of COVID-19 serology assays. COVID-19 serology. Malaysian J Pathol 2020; 42: 13-21.
• Brochot E, Demey B, Touzé A, et.al. Anti-spike, antinucleocapsid and neutralizing antibodies in SARS-CoV-2 inpatients and asymptomatic individuals. Front Microbiol 2020. doi.org/10.3389/fmicb.2020.584251
• Mariën J, Ceulemans A, Michiels J, et.al. Evaluating SARSCoV- 2 spike and nucleocapsid proteins as targets for antibody detection in severe and mild COVID-19 cases using a Luminex bead-based assay. 2021;288:114025. doi.org/10.1016/j. jviromet.2020.114025
• Grzelak L, Temman S, Planchais C, et al. A comparison of four serological assays for detecting anti–SARS-CoV-2 antibodies in human serum samples from different populations. Sci Transl Med 2020;12:eabc3103. doi: 10.1126/scitranslmed. abc3103.
• Beavis, KG, Matushek SM, Abeleda A P F, et.al. Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies. J Clin Virol 2020; 129: 104468. doi:10.1016/j.jcv.2020.104468.
• Jääskeläinen A J, Kuivanen S , Kekäläinen E , et.al. Performance of six SARS-CoV-2 immunoassays in comparison with microneutralisation. J Clin Virol 2020; 129: 104512. doi:10.1016/j.jcv.2020.104512.
• Evaluation of sensitivity and specificity of four commercially available SARS-CoV-2 antibody immunoassays. Public Health England, Porton Down Nuffield Department of Medicine, University of Oxford Oxford University Hospitals NHS Foundation Trust, July 2020.
• Mariën J, Ceulemans A, Michiels J, et.al. Evaluating SARSCoV- 2 spike and nucleocapsid proteins as targets for antibody detection in severe and mild COVID-19 cases using a Luminex bead-based assay, J Virol Metods 2021;288:114025. doi.org/10.1016/j.jviromet.2020.114025
• Nicol T, Lefeuvre C, Serri O, et.al. Assessment of SARS-CoV-2 serological tests for the diagnosis of COVID-19 through the evaluation of three immunoassays: Two automated immunoassays (Euroimmun and Abbott) and one rapid lateral flow immunoassay (NG Biotech) J Clin Virol 2020; 129: 104511. doi: 10.1016/j.jcv.2020.104511.
• Şener B, Kırbaş E, Sancak B, et.al. Sensitivity affected by disease severity and serum sampling time: a performance evaluation of six SARS-CoV-2 antibody immunoassays. Jpn J Infect Dis 2022;75:388-94. doi: 10.7883/yoken.JJID.2021.636
• Jääskeläinen AJ, Kekäläinen E, Hannimari Kallio-Kokko H, et.al. Evaluation of commercial and automated SARS-CoV-2 IgG and IgA ELISAs using coronavirus disease (COVID-19) patient samples. Euro Surveill 2020;25:2000603. doi: 10.2807/1560-7917.ES.2020.25.18.2000603.
• Pflüger LS, Johannes H Bannasch J H , Thomas Theo Brehm TT, et.al. Clinical evaluation of five different automated SARSCoV- 2 serology assays in a cohort of hospitalized COVID-19 patients. J Clin Virol 2020; 130: 104.549.2020 doi: 10.1016/j. jcv.2020.104549
• Schnurra C , Reiners N , Biemann R , Kaiser T , Henning Trawinski H , Jassoy C. Comparison of the diagnostic sensitivity of SARS-CoV-2 nucleoprotein and glycoproteinbased antibody tests. J Clin Virol 2020;129:104544. doi: 10.1016/j.jcv.2020.104544.
• Hörber S, Soldo J, Relker L, et.al. Evaluation of three fullyautomated SARS-CoV-2 antibody assays. Clin Chem Lab Med 2020;58:2113-2120. doi: 10.1515/cclm-2020-0975.
• Kohmer N , Westhaus S, Rühl C, et.al. Brief clinical evaluation of six high-throughput SARS-CoV-2 IgG antibody assays. J Clin Virol 2020;129:104480. doi: 10.1016/j.jcv.2020.104480.
• Van Elslande J, Houben E , Depypere M, et.al. Diagnostic performance of seven rapid IgG/IgM antibody tests and the Euroimmun IgA/IgG ELISA in COVID-19 patients Clin Microbiol Infect 2020;26:1082-7. doi:10.1016/j. cmi.2020.05.023.
• Appak O, Gülmez A, Güzel I, et.al. Evaluation of COVID-19 antibody response with three different tests. SS-084. 25-27 December, 2020, TMC Online symposium.
• Wang P. Combination of serological total antibody and RT-PCR test for detection of SARS-COV-2 infections. J Virol Methods 2020;283:113919. doi: 10.1016/j.jviromet.2020.113919
• Burbelo P D, Riedo F X, Morishima C, et al. 4 4Sanchita DasDetection of nucleocapsid antibody to SARS-CoV-2 is more sensitive than antibody to spike protein in COVID-19 patients. version 1. medRxiv. Preprint. 2020; 2020.04.20.20071423. doi: 10.1101/2020.04.20.20071423
• Kai-Wang To K, Tak-Yin Tsang O, Leung W-S, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARSCoV- 2: an observational cohort study. Lancet Infect Dis 2020; 20: 565-74. doi: 10.1016/S1473-3099(20)30196-1.