A Synchronous Blind Test and Methodological Comparison Between Colloidal Gold Rapid Test vs RT-PCR For Sars-Cov-2 Detection



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Submitted Oct 28, 2022
Published Nov 30, 2022
10.24018/ejbiomed.2022.1.5.26

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Background: The current pandemic due to novel SARS-CoV-2 virus dramatically affected health care systems and public health worldwide. The present study aimed to evaluate two analytical methods, colloidal gold antigen rapid test vs reference PCR for the detection of SARS-CoV-2. The patients enrolled in the trial were admitted at the emergency department of a tertiary care hospital, with symptoms of suspected COVID-19 disease.

Methods: A total of 300 patients participated in the study. Patients’ age, gender and result from the Colloidal antigen rapid test were recorded. PCR detection for SARS-CoV-2 was then applied, according to the manufacturer’s instructions. Statistical analysis of all collected data was performed for sensitivity, specificity, ROC curves, PV+, PV- and Cohen’s kappa coefficient. McNemar’s chi-squared test and p-values were also tested.

Results: A p-value=0.045 from McNemar’s chi-squared test for CI 95% was observed, so H0 marginally is not rejected. The sensitivity of colloidal gold antigen rapid test was 79%, the specificity 96%, PV+89%, PV-91% and the kappa coefficient=0.79 (>0.5) that correlates to substantial agreement according to Cohen’s Kappa interpretation.

Conclusions: Through the methodological comparisons and according to WHO guidelines for the sensitivity, specificity and kappa coefficient that correlates to substantial agreement the Colloidal Gold Antigen Rapid Test for SARS-CoV-2 meet the needs of clinical test in the emergency unit playing an important role in the context of mass patient screening and screening in remote areas.

Keywords: Antigen Rapid Test, COVID-19, ECDC, kappa coefficient, PCR, ROC curves, SARS-CoV-2, sensitivity, specificity, WHO.

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References

  1. WHO Director-General’s opening remarks at the media briefing on COVID-19 [Internet]. 11 March 2020 n.d. Available from: https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19-11-march-2020N.
     Google Scholar
  2. Zhu Ν, Zhang D, Wang W, Li X, Yang B, Song J, et al. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020; 382(8):727–733. http://dx.doi.org/10.1056/NEJMoa2001017.
    DOI  |   Google Scholar
  3. Guo YR, Cao QD, Hong ZS, et al. The origin, transmission, and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak-an update on the status. Mil Med Res. 2020;7(1):11. doi:10.1186/s40779-020-00240-0.
    DOI  |   Google Scholar
  4. Mei H, Pond SK, Nekrutenko A. Stepwise evolution, and exceptional conservation of orf1a/b overlap in coronaviruses. Molecular Biology and Evolution. 2021; 38(12): 5678–5684, https://doi.org/10.1093/molbev/msab265.
    DOI  |   Google Scholar
  5. WHO Tracking SARS-CoV-2 variants [Internet]. Available from: https://www.who.int/activities/tracking-SARS-CoV-2-variants.
     Google Scholar
  6. ECDC SARS-CoV-2 variants of concern as of 11 August 2022 [Internet]. Available from: https://www.ecdc.europa.eu/en/covid-19/variants-concern.
     Google Scholar
  7. CDC SARS-CoV-2 Variant Classifications and Definitions [Internet]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-classifications.html.
     Google Scholar
  8. Yashvardhini N, Kumar A, Jha DK. Analysis of SARS-CoV-2 mutations in the main viral protease (NSP5) and its implications on the vaccine designing strategies. Vacunas. 2022 May;23: S1-S13. doi: 10.1016/j.vacun.2021.10.002. Epub 2021 Dec 3. PMID: 34876891; PMCID: PMC8639442.
    DOI  |   Google Scholar
  9. Mungomklang A, Trichaisri N, Jirachewee J, Sukprasert J, Tulalamba W, Viprakasit V. Limited sensitivity of a rapid Sars-Cov-2 antigen detection assay for surveillance of asymptomatic individuals in thailand. Am J Trop Med Hyg. 2021;105(6):1505-1509. doi: 10.4269/ajtmh.21-0809. PMID: 34634778; PMCID: PMC8641330.
    DOI  |   Google Scholar
  10. Acter T, Uddin N, Das J,3, Akhter A, Choudhury TR, Sunghwan Kim S. Evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as coronavirus disease 2019 (COVID-19) pandemic: A global health emergency. Sci Total Environ. 2020; 730: 138996. DOI: 10.1016/j.scitotenv.2020.138996.
    DOI  |   Google Scholar
  11. Ceraolo C. and Giorgi FM. Genomic variance of the 2019-nCoV coronavirus. J Med Virol. 2020; 92(5): 522–528. DOI: 10.1002/jmv.25700.
    DOI  |   Google Scholar
  12. Webb WR, Thapa G, Tirnoveanu A, Kallu S, Loo Jin Yi C, Shah N, et al. Single vs replicate Real-Time PCR SARS-CoV-2 testing: Lessons learned for effective pandemic management. PLoS ONE. 2022; 17(7): e0269883. https://doi.org/10.1371/journal.pone.0269883.
    DOI  |   Google Scholar
  13. Ferte T, Ramel V, Cazanave C, Lafon M-E, Bébéar C, Malvy D, et al. Accuracy of COVID-19 rapid antigenic tests compared to RT-PCR in a student population: The StudyCov study. J Clin Virol. 2021; 141:104878. doi: 10.1016/j.jcv.2021.104878. https://doi.org/10.1016/j.jcv.2021.104878.
    DOI  |   Google Scholar
  14. World Health Organization. Antigen-detection in the Diagnosis of SARS-CoV-2 Infection Using Rapid Immunoassays (2020) [Internet] [accessed December 9, 2020]. Available from: https://www.who.int/publications-detail-redirect/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays.
     Google Scholar
  15. Dinnes J, Deeks JJ, Adriano A, Berhane S, Davenport C, Dittrich S, et al. Rapid, point-of-care antigen, and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2020;8(8):CD013705.
    DOI  |   Google Scholar
  16. Carpenter CR. Rapid antigen and molecular tests had varied sensitivity and ≥97% specificity for detecting SARS-CoV-2 infection. Ann Intern Med. 2020 Dec 15;173(12): JC69. doi: 10.7326/ACPJ202012150-069.
    DOI  |   Google Scholar
  17. Ngaba, GP, Kalla GCM, Assob JCN, Njouendou AJ, Jembe CN, Mboudou ET, et al. Evaluation of two COVID-19 antigenic diagnostic tests: BIOSYNEX® COVID-19 Ag BSS and BIOSYNEX® COVID-19 Ag+BSS compared to AmpliQuick® SARS-CoV-2 PCR]. / Evaluation de deux tests de diagnostic antigénique du COVID-19: BIOSYNEX® COVID-19 Ag BSS et BIOSYNEX® COVID-19 Ag+BSS comparés à la PCR AmpliQuick® SARS-CoV-2. Pan Afr Med J. 2021; 39: 228.
    DOI  |   Google Scholar
  18. Brakenhoff TB, Franks B, Goodale BM, van de Wijgert J, Montes S, Veen D, et al. A prospective, randomized, single-blinded, crossover trial to investigate the effect of a wearable device in addition to a daily symptom diary for the remote early detection of SARS-CoV-2 infections (COVID-RED): a structured summary of a study protocol for a randomized controlled trial. Trials. 2021; volume 22, Article number: 412.
    DOI  |   Google Scholar
  19. Chu C-M, Poon LLM, Cheng VCC, Chan K-S, Hung IFN, Wong MML, et al. Initial viral load and the outcomes of SARS. CMAJ. 2004; 171(11): 1349–135.
    DOI  |   Google Scholar
  20. Fernandez-Montero A, Argemi J, Rodríguez JA, Ariño AH, and Moreno-Galarraga L. Validation of a rapid antigen test as a screening tool for SARS-CoV-2 infection in asymptomatic populations. Sensitivity, specificity, and predictive values. EClinicalMedicine. 2021; 37: 100954. doi: 10.1016/j.eclinm.2021.100954.
    DOI  |   Google Scholar
  21. Ng EK, Hui DS, Chan KC, et al. Quantitative analysis, and prognostic implication of SARS coronavirus RNA in the plasma and serum of patients with severe acute respiratory syndrome. Clin Chem. 2003; 49:1976–80.
    DOI  |   Google Scholar
  22. Li J, Martin FL. Current Perspective on Nanomaterial-Induced Adverse Effects. Neurotoxicity of Nanomaterials and Nanomedicine; 2017.
    DOI  |   Google Scholar
  23. Ebara M, Uto K. Gold nanomaterials for gene therapy. Polymers and Nanomaterials for Gene Therapy; 2016.
    DOI  |   Google Scholar
  24. KarimollahHajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics), (24). Journal of Biomedical Informatics. 2014; 48:193–204. https://doi.org/10.1016/j.jbi.2014.02.013.
    DOI  |   Google Scholar
  25. Rosner B. Fundamentals in Biostatistics. 8th Edition. Harvard University; 2016.
     Google Scholar
  26. Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther. 2005;85(3):257-68.
    DOI  |   Google Scholar
  27. Agresti A, & Coull BA. Approximate is Better than “Exact” for Interval Estimation of Binomial Proportions. The American Statistician. 1998; 52(2):119-126.
    DOI  |   Google Scholar


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