Original Article
  

Diagnosis of COVID-19 by Serology in Admitted Patients with Negative RT-PCR Assay

Abstract

Considering the increasing prevalence and burden of coronavirus disease 2019 (COVID-19) disease and false-negative results in routine reverse transcription-polymerase chain reaction (RT-PCR) tests, additional diagnostic methods are needed to diagnose active cases of this disease.
This prospective study was conducted on patients, in whom clinical and radiological symptoms/signs were in favor of COVID-19 while their first PCR test was negative. Later on, a second RT-PCR was performed and serological evaluation was carried out and results were compared with each other.
Out of 707 patients who had been referred to the hospital and were clinically and radiologically suspicious of disease, 137 patients with negative RT-PCR tests entered the study. RT-PCR assay became positive for the second time in 45 (32.8%). Anti-COVID-19 IgM and IgG antibodies were positive in 83 (60.6%) and 86 (62.8%) patients, respectively. Finally, it was determined that serological test was diagnostic in 73% of patients and the diagnostic yield of serology was significantly higher after the first week of illness (54.8% in the first week and 88% after that). Taking advantage of both serological tests and RT-PCR helps in diagnosing 83.9% of cases.
Based on the present study, the serology may be useful as a complementary test and in parallel to RT-PCR assay for diagnosis of COVID-19 among admitted symptomatic cases.

1. Zhu N, 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):727-33.
2. Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020;395(10223):470-3.
3. Berlin DA, Gulick RM, Martinez FJ. Severe Covid-19. N Engl J Med. 2020.
4. Falaschi Z, Danna PSC, Arioli R, Pasche A, Zagaria D, Percivale I, et al. Chest CT accuracy in diagnosing COVID-19 during the peak of the Italian epidemic: A retrospective correlation with RT-PCR testing and analysis of discordant cases. Eur J Radiol. 2020;130:109192.
5. Kubina R, Dziedzic A. Molecular and Serological Tests for COVID-19 a Comparative Review of SARS-CoV-2 Coronavirus Laboratory and Point-of-Care Diagnostics. Diagnostics (Basel, Switzerland). 2020;10(6):8-10.
6. Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, et al. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. 2020;323(18):1843-4.
7. Younes N, Al-Sadeq DW, Al-Jighefee H, Younes S, Al-Jamal O, Daas HI, et al. Challenges in Laboratory Diagnosis of the Novel Coronavirus SARS-CoV-2. Viruses. 2020;12(6):12-7.
8. Peaper DR, Landry ML. Laboratory diagnosis of viral infection. Handb Clin Neurol. 2014;123(6):123-47.
9. Bastos ML, Perlman-Arrow S, Menzies D, Campbell JR. The Sensitivity and Costs of Testing for SARS-CoV-2 Infection With Saliva Versus Nasopharyngeal Swabs : A Systematic Review and Meta-analysis. Annals of internal medicine. 2021;174(4):501-10.
10. Corman VM, Landt O, Kaiser M, Molenkamp R, Meijer A, Chu DK, et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Eurosurveillance. 2020;25(3):2000045.
11. World Health O. Clinical management of severe acute respiratory infection (‎‎SARI)‎‎ when COVID-19 disease is suspected: interim guidance, 13 March 2020. Geneva: World Health Organization, 2020. Report No.: Contract No.: WHO/2019-nCoV/clinical/2020.4.
12. Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020;323(13):1239-42.
13. Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, et al. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. 2020;323(18):1843-4.
14. Lim J, Lee J. Current laboratory diagnosis of coronavirus disease 2019. Korean J Intern Med. 2020;35(4):741-8.
15. Wang P. Combination of serological total antibody and RT-PCR test for detection of SARS-COV-2 infections. J Virol Methods. 2020;283:113919.
16. Bauer G. The variability of the serological response to SARS-corona virus-2: Potential resolution of ambiguity through determination of avidity (functional affinity). J Med Virol. 2020;93(1):311-22.
17. 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;71(8):1930-4.
18. Guo L, Ren L, Yang S, Xiao M, Chang, Yang F, et al. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. 2020;71(15):778-85.
19. Krammer F, Simon V. Serology assays to manage COVID-19. Science. 2020;368(6495):1060-1.
20. Siracusano G, Pastori C, Lopalco L. Humoral Immune Responses in COVID-19 Patients: A Window on the State of the Art. Front Immunol. 2020;11(5):1049-54.
21. To KK-W, Tsang OT-Y, Leung W-S, Tam AR, Wu T-C, Lung DC, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. The Lancet Infectious Diseases. 2020;20(5):565-74.
22. Liu W, Liu L, Kou G, Zheng Y, Ding Y, Ni W, et al. Evaluation of Nucleocapsid and Spike Protein-Based Enzyme-Linked Immunosorbent Assays for Detecting Antibodies against SARS-CoV-2. J Clin Microbiol. 2020;58(6):32-9.
23. Espejo AP, Akgun Y, Al Mana AF, Tjendra Y, Millan NC, Gomez-Fernandez C, et al. Review of Current Advances in Serologic Testing for COVID-19. Am J Clin Pathol. 2020;154(3):293-304.
24. Lisboa Bastos M, Tavaziva G, Abidi SK, Campbell JR, Haraoui LP, Johnston JC, et al. Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis. BMJ. 2020;370:m2516.
25. West CP, Montori VM, Sampathkumar P. COVID-19 Testing: The Threat of False-Negative Results. Mayo Clin Proc. 2020;95(6):1127-9.
26. Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis. 2020;71(16):2027-34.
27. World Health Organization .Clinical management of COVID-19. Interim guidance. 27 May 2020, WHO reference number: WHO/2019-nCoV/clinical/2020.5 [cited 2020 August 26] Available from: https://www.who.int/publications/i/item/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-suspected. 2020.
28. Kimberly E, Hanson, Angela M, Caliendo, Cesar A, Arias J, et al. Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Serologic Testing. [cited 2020 August 26] Available from: https://www.idsociety.org/COVID19guidelines/serology. 2020.
29. China National Health Commission, 2020. China National Health Commission, 2020. Diagnosis and Treatment of 2019-nCoV Pneumonia in China (Version 7) In Chinese. Accessed 4 March 2020. http://www.nhc.gov.cn/yzygj/s7653p/202003/46c9294a7dfe4cef80dc7f5912eb1989.shtml.
Files
IssueVol 20 No 4 (2021) QRcode
SectionOriginal Article(s)
DOI https://doi.org/10.18502/ijaai.v20i4.6949
Keywords
Antibodies COVID-19 Diagnosis Reverse transcription polymerase chain reaction Serology
Rights and permissions
Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
How to Cite
1.
Rezaei M, Baghaei P, Sadr M, Moniri A, Babamahmoodi A, Qadimi S, Porabdollah M, Nadji SA, Tabarsi P, Marjani M. Diagnosis of COVID-19 by Serology in Admitted Patients with Negative RT-PCR Assay. Iran J Allergy Asthma Immunol. 2021;20(4):394-401.