medigraphic.com
ISSN 1561-3054 (Electronic)

2022, Number 1

<< Back Next >>

Rev Cubana Med Trop 2022; 74 (1)

Evaluation of ultramicroanalytic assays to detect antibodies against SARS-CoV-2

Rodriguez LLÁ, Tejero Y, Pelegrino JL, Morales VDD, Montalvo MC, Valdés O, Resik S, Guzmán MG

Language: Spanish
References: 24
Page:
PDF size: 444.44 Kb.


ABSTRACT

Introduction: This paper shows the results obtained in the validation of in vitro serological assays to detect IgM, IgG antibodies, and total antibodies against SARS-CoV-2 UMELISA SARS-CoV-2 IgM, UMELISA ANTI-SARS-CoV-2 and UMELISA SARS-CoV-2 IgG developed by the Immunoassay Center.
Methods: Panels of serum samples from negative and COVID-19 confirmed patients were used to determine the analytical performance of each assay.
Results: UMELISA SARS-CoV-2 IgM, UMELISA ANTI-SARS-CoV-2 and UMELISA SARS-CoV-2 IgG assays demonstrated 100% clinical specificity for all assays; and 100% analytical specificity for the first two assays, and 93.1% for the last one. Clinical sensitivity was 64.3%, 80.8% and 97.5%, respectively. The positive predictive value was 100% in all assays, while the negative predictive value ranged from 83.3% to 95.2%. Concordance varied from 92.4% to 96.9%, and kappa index in every assay was very good. Assays sensitivity increased to 82.7%, 96.5% and 100 %, respectively for serum samples collected more than 14 days after onset of the symptoms.
Conclusions: The assays demonstrated high sensitivity and specificity, which allows us to have Cuban technology-based tools for serological, epidemiological surveillance, and other types of studies, including those related to vaccines on a platform with wide national distribution.


REFERENCES

  1. WHO. Cronología de la respuesta de la OMS a la COVID-19, 29 de junio de 2020. [Acceso 14/10/2020]. Disponible en: Disponible en: https://www.who.int/es/news/item/29-06-2020-covidtimeline

  2. Gorbalenya AE, Baker SC, Baric RS, de Groot RJ, Drosten C, Gulyaeva AA, et al. The species Severe acute respiratory syndrome related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nature Microbiology. 2020 March;5(536):536-44. DOI: http://doi.org/10.1038/s41564-020-0695-z

  3. Banerjee A, Kulcsar K, Misra V, Frieman M, Mossman K. Bats and coronaviruses. Viruses. 2019;11(1):e41. DOI: https://doi.org/10.3390/v11010041

  4. Heng L, Shang-Ming L, Xiao-Hua Y, Shi-Lin T, Chao-Ke T. Coronavirus disease 2019 (COVID-19): current status and future perspectives. Int J Antimicrob Agents. 2020 May;55(5):105951. DOI: https://doi.org/10.1016/j.ijantimicag.2020.105951

  5. Junejo Y, Ozaslan M, Safdar M, Khailanyd RA, Rehman S, Yousaf W, et al. Novel SARS-CoV-2/COVID-19: Origin, pathogenesis, genes and genetic variations, immune responses and phylogenetic analysis. Gene Rep. 2020 Sep;20:100752. DOI: https://doi.org/10.1016/j.genrep.2020.100752

  6. Uddin M, Mustafa F, Rizvi TA, Loney T, Suwaidi HA, Hassan Al-Marzouqi AH, et al. SARS-CoV-2/COVID-19: Viral Genomics, Epidemiology, Vaccines, and Therapeutic Interventions. Viruses 2020;12:526. DOI: https://doi.org/10.3390/v12050526

  7. La Marca A, Capuzzo M, Paglia T, Roli L, Trenti T, Nelson SM. Testing for SARS-CoV-2 (COVID-19): A systematic review and clinical guide to molecular and serological in-vitro diagnostic assays. RBMO. 2020 [Acceso 05/11/2020];41(3). Disponible en: Disponible en: https://www.rbmojournal.com/article/S1472-6483(20)30318-7/pdf

  8. Winter AK, Hegde ST. The important role of serology for COVID-19 control. Lancet Infect Dis. 2020 Jul;20(7):758-9. DOI: https://doi.org/10.1016/S1473-3099(20)30322-4

  9. CECMED. Regulación No. 47/2007. Requisitos para la evaluación del desempeño de los diagnosticadores 2020[Acceso 05/11/2020]. Disponible en: Disponible en: http://www.sld.cu/galerias/pdf/uvs/patologiaclinica/reg_47-07[1].pdf

  10. Guadis Salazar E, Rodriguez Lay L, Montalvo Villalba M, Bello Corredor M, López Hernandez D, Marrero Sánchez B, et al. Android applications for viral hepatitis diagnosis, research and training. J International AIDS Society. 2018 [Acceso 05/11/2020];21(S3):e25093. Disponible en: Disponible en: https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.25093

  11. Tré-Hardy M, Blairon L, Wilmet A, Beukinga I, Malonne H, Dogné JM, et al. The role of serology for COVID-19 control: Population, kinetics and test performance do matter. Journal of Infection. J Infect. 2020 Aug;81(2):e91-e92. DOI: https://doi.org/10.1016/j.jinf.2020.05.019

  12. Liu L, Liu W, Zheng Y, Jiang X, Kou G, Ding J, et al. A preliminary study on serological assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 238 admitted hospital patients. Microbes and Infection. 2020;05(8). DOI: https://doi.org/10.1016/j.micinf.2020.05.008

  13. To KK-W, Tsang OT-Y, Leung W-S. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: An observational cohort study. Lancet Infect Dis. 2020;20(5):565-74. DOI: https://doi.org/10.1016/j.micinf.2020.05.008

  14. Zhao J, Yuan Q, Wang H. Antibody responses to SARS-CoV-2 in patients with novel coronavirus disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-34. DOI: https://doi.org/10.1016/S1473-3099(20)30196-1

  15. Burbelo PD, Riedo FX, Morishima C, Rawlings S, Smith D, Das S, et al. Detection of Nucleocapsid Antibody to SARS-CoV-2 is More Sensitive than Antibody to Spike Protein in COVID-19 Patients. medRxiv reprint. 20/04/2020 DOI: https://doi.org/10.1101/2020.04.20.20071423

  16. Okba NM, Muller MA, Li W, Wang C, Geurtsvan Kessel CH, Corman VM, et al. SARS-CoV-2 specific antibody responses in COVID-19 patients. medRxiv. 2020. [Acceso 05/11/2020]. Disponible en: Disponible en: https://www.medrxiv.org/content/10.1101/2020.03.18.20038059v1

  17. Muench P, Jochum S, Wenderoth V, Ofenloch-Haehnle B, Hombach M, Strobl M, et al. Development and Validation of the Elecsys Anti-SARS-CoV-2 Immunoassay as a Highly Specific Tool for Determining Past Exposure to SARS-CoV-2. J Clin Microbiol. 2020;58(10):e01694-20. DOI: https://doi.org/10.1128/JCM.01694-20

  18. OPS. Interpretación de resultados de laboratorio para diagnóstico de COVID-19. OPS; 6 may 2020. Disponible en: https://iris.paho.org/bitstream/handle/10665.2/52129/OPSPHEIHMCOVID-19200015_spa.pdf?sequence=1&isAllowed=y

  19. Russo A, Minichini C, Starace M, Astorri R, Calò F, Coppola N, et al. Current Status of Laboratory Diagnosis for COVID-19: A Narrative Review. Infection and Drug Resistance. 2020;13:2657-65. DOI: https://doi.org/10.2147/IDR.S264020

  20. Zhao J. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-34. DOI: https://doi.org/10.1093/cid/ciaa344

  21. Xiang F, Wang X, He X, Peng Z, Yang B, Zhang J, et al. Antibody Detection and Dynamic Characteristics in Patients with COVID-19. Clin Infect Dis. 2020 Nov;71(8):1930-4. DOI: https://doi.org/10.1093/cid/ciaa461

  22. Traugott M, Aberle SW, Aberle JH, Griebler H, Karolyi M, Pawelka E, et al. Performance of Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Assays in Different Stages of Infection: Comparison of Commercial Enzyme-Linked Immunosorbent Assays and Rapid Tests. The Journal of Infectious Diseases. 2020;222:362-6. DOI: https://doi.org/10.1093/infdis/jiaa305

  23. Lou B, Li T, Zheng S, Su Y, Li Z, Liu W, et al. Serology characteristics of SARS-CoV-2 infection since the exposure and post symptoms onset. 2020 March 27. medRxiv. 23/03/2020. Disponible en: https://www.medrxiv.org/content/10.1101/2020.03.23.20041707v1

  24. Abravanel F, Miédouge M, Chapuy-Regaud S, Mansuy JM, Izopet J. Clinical performance of a rapid test compared to a microplate test to detect total anti SARS-CoV-2 antibodies directed to the spike protein. J Clin Virol. 2020;130:104528. DOI: https://doi.org/10.1016/j.jcv.2020.104528




2020     |     www.medigraphic.com