Comparative Evaluation of ELISA and Real-time PCR Tests to Detect COVID-19
,
Abstract
Background: Considering the wide spread of covid-19 and its high death rate, it is very important to find a sensitive and accurate diagnostic method. Thus, this study compared two main diagnostic approaches; PCR and ELISA, to detect COVID-19.
Methods: Fifty patients admitted to Baghiyatalah Hospital were examined to detect COVID-19 RNA by Real-time PCR method, as well as for the presence of IgG and IgM antibodies by ELISA method. The results were statistically analysed by SPSS software.
Results: The mean age of patients is 38.4 years old. The percentage of positive cases of COVID-19 in the studied patients according to PCR and ELISA tests was 66% and 70%, respectively. There was a statistically significant difference between positive cases of COVID-19 detected by PCR and ELISA with emerging fever, weakness, and lethargy . The diagnostic value of ELISA versus PCR showed that the sensitivity, specificity, positive likelihood ratio, and true positive rate were 100%, 88.2%, 8.5, and 94.29%, respectively.
Conclusion: Although the sensitivity of detection in Real-time PCR is higher than that in ELISA, there is a high agreement between the two methods when used for diagnosis of COVID-19.
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31. Wang M, Wu Q, Xu W, et al. Clinical diagnosis of &274 samples with 2019-novel coronavirus in Wuhan. Med Rxiv 2020;10.1101.
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34. European centre for disease prevention and control .An overviews in the rapid test situation for Covid -19 diagnosis in the EU/EEA. stockholm :Eu/EEA.stockholm:European centre for disease ptevention and control ,2020.
35. Xu Z, Shi Y, Wang Y,et al.pathological findings of covid 19 associated with acute respiratory distress syndrome. Lancet Resp Med 2020; 25:126-132.
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37. Fox T, Geppert J, Dinnes J, et al. Cochrane COVID-19 diagnostic test accuracy group. Antibody tests for identification of current and past infection with SARS-CoV-2. Cochrane Database Syst Rev 2022; 11(11):CD013652.
38. Omer A, Osman OR. Comparison of real -time reverse transcriptase polymerase chain reaaction and IgM and IgG antibody test for the diagnosis of SARS-CoV-2 in infection. J Teknol Laboratorium.2020;
39. Shamsollahi HR, Amini M, Alizadeh S, et al. Validity of a serological diagnostic kit for SARS-CoV 2 available in Iran. Arch Iran Med 2020; 23(9):629-32.
40. Vali M, Mirahmadizadeh A, Malek Z. Comparison of pcr test Accurancy with Laboratory Data and CT scan in COVID 19 A systematic Review. J Health sci surveillance sys 2021; 9(1):2-10.
41. Hoffman T, Nissenb K, Krambrich J. Evaluation of a COVID 19 IgM and IgG rapid test; an efficient tool for assessment of past exposure to SARS -COV 2 Infect Ecol Epidemiology 2020; 10:1754538.
42. Rui L, Xinghui L, Huan H..The comparative superiority of IgM -IgG antibody test to real -time reverse 2 transcriptase PCR detection for SARS-COV 2 infection diagnosis. med Rxiv 2020.
43. Huang C, Wang Y, Li X, et al. Clinical features of patients infect with 2019 novel coronavirus in Wuhan, China. Lancet 2020;395:497-506.
44. Jiang F, Deng L, Zhang L, et al. Review of the clinical characteristics of coronsvirus diseade 2019. J Gen Intetn Med. 2020;31:1-5.
45. Jitian Li,Zhec khan,Yifei Nie,Yan Ma,Qiaoyun Gua ,et al.Identification of symptoms prognostic of covid 19 Journal of medical Internet research .2020;22(6):e19639.
46. Cares-Marambio K, Montenegro-Jiménez Y, Torres-Castro R, et al. Prevalence of potential respiratory symptoms in survivors of hospital admission after coronavirus disease. Chron Respir Dis 2020; 25:273-81.
2. Richman DD, Whitley RJ, Hayden FG. Clinical virology: John Wiley & Sons; 2016.
3. Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (covid-19) outbreak in China: summary of a report of 72 314 cases from the chinese center for disease control and prevention. JAMA 2020; 323(13):1239-42.
4. Zhang L, Lin D, Kusov Y, et al. α--ketoamides as broad-spectrum inhibitors of coronavirus and enterovirus replication: Structure-based design, synthesis, and activity assessment. J Med Chem 2020; 63(9):4562-78.
5. Xu X, Chen P, Wang J, et al. Evolution of the novel cotonavirus from the ongoing Wuhan out break and modeling of its spike protein for risk of human transmission. Sci china Life Sci 2020; 63(3): 45-60.
6. Gralinski LE, Menachery VD. Return of the coronavirus: 2019-ncov. Viruses 2020; 12(2):135.
7. Xu K, Lai X, Liu Z. Suggestions for prevention of 2019 novel coronavirus infection in otolaryngology head and neck surgery medical staff. Chinese journal of otorhinolaryngology head and neck surgery 2020; 55(0):E001.
8. Yoo JH. The fight against the 2019-nCoV outbreak: an arduous march has just begun. J Korean Med Sci 2019; 35(4):e56.
9. Wan Y, Shang J, Sun S, et al. Molecular mechanism for antibody dependent enhancement of coronavirus entry. J virology 2020; 94(5):210-23.
10. Lee YL, Liao CH, Liu PY, et al. Dynamics of anti-Sars.cov 2IgM and IgG antibodies among COVID 19 patients. J Infect 2020; 25(4):253-60.
11. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol 2019; 17(3):181-92.
12. Banerjee A, Kulcsar K, Misra V, et al. Bats and coronaviruses. Viruses 2019; 11(1):41.
13. Li XW, Manman G, Yizhao P, Molecular immune pathogenesis and diagnosis of COVID -19. J Pharm Anal 2020; 10(12):102-8.
14. Tian X, Li A, Huang A, et al. Potent binding of 2019 novel coronavirus spike protein by a SARS coronavirus specific human monoclonal antibody. Emerg Microb Infect 2020; 9:382-385.
15. Li G, Chen A, Xu G. Profile of specific antibodies to the SARS-associated coronavirus. N Engl J Med 2003; 349:508-513.
16. Xu Z, Shi L, Wang Y, et al. Pathological findings of COVID 19 associated with acute respiratory distress syndrome. Lancet Resp Med 2020; 25:126-132.
17. Vidal-Anzardo M, Solis G, Solari L, et al. Evaluation of a rapid serological test for detection of IgM and IgG antibodies against sars-cov-2 under field conditions. Rev Peru Med Exp Salud Publica 2020; 372:5534.
18. Zhao J, Yuan Q, Wang H, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis 2020; 71(16):2027-34.
19. Corman VM, Landt O, Kaiser M, et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill 2020; 25(3):2000045.
20. Tang B, Wang X, Li Q, et al. Estimation of the transmission risk of the 2019-n cove. Its Implication for public health intervention. J Clin Med 2020; 9(2):10-3390
21. Chinese CDC, specific primers and probes for detection 2019 novel coronavirus.
22. Zhou D, Lou YX, Wang X, et al.A pneumonia out break associated with a new coronavirus of probable bat origin. Nature 2020; 579: 270-3.
23. World Health organizatiin .Director General's opening remarks at the media briefing on Covid -19. 11 March 2020.
24. Abbott A. SARS testing: First past the post. Nature 2003; 8;423(6936):114.
25. White LF, Pagano M. A likelihood-based method for real-time estimation of the serial interval and reproductive number of an epidemic. Stat Med 2008; 27(16):2999-3016.
26. Tahamtan A, Ardebili A. Real-time RT-PCR in COVID-19 detection: issues affecting the results. Expert Rev Mol Diagn 2020; 20(5):453-4.
27. AI T, Yang Z, Hou H, et al. eorrelation of chest CT and RT.PCR testing for coronavirus disease 2019 (covid 19) in China. Radiology 2020; 296:E32-E40.
28. He JL, Lin Luo L, Luo ZD, et al. Diagnostic performance between CT and initial real-time RT-PCR for clinically suspected 2019 coronavirus disease (COVID-19) patients outside Wuhan, China. Respir Med 2020; 168:105980.
29. Zhou P,Yang XL,Wang XG, et al. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature 2020; 579(10):1038.
30. Sun ZF, Meng XJ. Antigenic cross reactivity between the nucleocapsid protein of severe acute respiratory syndrome (SARS) corona virus and polyclonal antisera of antigenic group I animal coronaviruses. J clin Microbiol 2004; 42(5):2351-2.
31. Wang M, Wu Q, Xu W, et al. Clinical diagnosis of &274 samples with 2019-novel coronavirus in Wuhan. Med Rxiv 2020;10.1101.
32. Choe JY, Kim JW. Diagnostic performance of immunochromatography assay for rapid detection of IgM and IgG in cotonavirus disease 2019. J Med virol 2020; 92(11):2567-72.
33. Ong DSY, De Man SJ, Linde boom FA, et al .Comparison of diagnostic accuracies of rapid serological tests and ELISA to molecular diagnostics in patients with susoected coronavirus disease 2019 presenting to the hospital. Clin Microbiol Infect 2020; 26(8):e7-1094.
34. European centre for disease prevention and control .An overviews in the rapid test situation for Covid -19 diagnosis in the EU/EEA. stockholm :Eu/EEA.stockholm:European centre for disease ptevention and control ,2020.
35. Xu Z, Shi Y, Wang Y,et al.pathological findings of covid 19 associated with acute respiratory distress syndrome. Lancet Resp Med 2020; 25:126-132.
36. Zhao S, Lin Q, Ran J, et al. Preliminary estimation of the basic reproduction number of novel coronavirus (2019-nCoV) in China, from 2019 to 2020: A data-driven analysis in the early phase of the outbreak. Int J Infect Dis 2020; 92:214-17.
37. Fox T, Geppert J, Dinnes J, et al. Cochrane COVID-19 diagnostic test accuracy group. Antibody tests for identification of current and past infection with SARS-CoV-2. Cochrane Database Syst Rev 2022; 11(11):CD013652.
38. Omer A, Osman OR. Comparison of real -time reverse transcriptase polymerase chain reaaction and IgM and IgG antibody test for the diagnosis of SARS-CoV-2 in infection. J Teknol Laboratorium.2020;
39. Shamsollahi HR, Amini M, Alizadeh S, et al. Validity of a serological diagnostic kit for SARS-CoV 2 available in Iran. Arch Iran Med 2020; 23(9):629-32.
40. Vali M, Mirahmadizadeh A, Malek Z. Comparison of pcr test Accurancy with Laboratory Data and CT scan in COVID 19 A systematic Review. J Health sci surveillance sys 2021; 9(1):2-10.
41. Hoffman T, Nissenb K, Krambrich J. Evaluation of a COVID 19 IgM and IgG rapid test; an efficient tool for assessment of past exposure to SARS -COV 2 Infect Ecol Epidemiology 2020; 10:1754538.
42. Rui L, Xinghui L, Huan H..The comparative superiority of IgM -IgG antibody test to real -time reverse 2 transcriptase PCR detection for SARS-COV 2 infection diagnosis. med Rxiv 2020.
43. Huang C, Wang Y, Li X, et al. Clinical features of patients infect with 2019 novel coronavirus in Wuhan, China. Lancet 2020;395:497-506.
44. Jiang F, Deng L, Zhang L, et al. Review of the clinical characteristics of coronsvirus diseade 2019. J Gen Intetn Med. 2020;31:1-5.
45. Jitian Li,Zhec khan,Yifei Nie,Yan Ma,Qiaoyun Gua ,et al.Identification of symptoms prognostic of covid 19 Journal of medical Internet research .2020;22(6):e19639.
46. Cares-Marambio K, Montenegro-Jiménez Y, Torres-Castro R, et al. Prevalence of potential respiratory symptoms in survivors of hospital admission after coronavirus disease. Chron Respir Dis 2020; 25:273-81.
| Files | ||
| Issue | Vol 12 No 1 (2024) | |
| Section | Original Articles | |
| DOI | https://doi.org/10.18502/jmb.v12i1.15019 | |
| Keywords | ||
| COVID-19 Diagnosis ELISA Molecular Real-Time PCR. | ||
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How to Cite
1.
Moshashei S, Bashi Zadeh Fakhar H, Shaghaghi B, Jalalian M. Comparative Evaluation of ELISA and Real-time PCR Tests to Detect COVID-19. J Med Bacteriol. 2024;12(1):33-42.
