Evaluation of Immunochromatographic Antibody Test Results in Patients with Prediagnosis of COVID-19

Abstract

Background: COVID-19 is an infectious disease that starts with pneumonia and causes a pandemic in a short time. Detection of nucleic acid belonging to SARS-CoV-2, which is the cause of COVID-19, by RT PCR is the gold standard in diagnosis. Antibody response develops after 7-11 days in patients infected with SARS-CoV-2. In this study, the role of immunochromatographic antibody tests in the diagnosis of COVID-19 was investigated.
Materials and Methods: The results of the samples sent to the Medical Microbiology Laboratory for COVID-19 antibody testing of patients hospitalized with suspected COVID-19 were evaluated retrospectively. After obtaining serum from blood samples, colloidal gold-based immunochromatographic lateral flow test method was used. Laboratory values and radiological findings found simultaneously with the demographic characteristics of the patients were also included in the study.
Results: COVID-19 antibody positivity was detected in 50 (51%) of 98 patients included in the study. Eighteen (64.2%) of 28 patients in the definitive diagnosis group with PCR positivity had COVID-19 antibody positivity. Despite PCR negativity, 32 (45.7%) of the 70 patients in the pre-diagnosis group who met the radiology findings had COVID-19 antibody positivity. Eighteen of the 50 patients whose antibodies were found to be positive were found to have positive PCR results. Thirty-two patients were evaluated radiologically in favor of COVID-19 despite PCR negativity.
Conclusions: The gold standard in the diagnosis of COVID-19 is the detection of viral nucleic acid. Serological tests can be used in epidemiology, immune response monitoring and detection of asymptomatic cases. Since the role of serology in the diagnosis cannot be fully clarified and the sensitivity and specificity rates of different kits and devices are available, various studies on this subject will shed light on the diagnostic processes in the COVID-19 pandemic.

Keywords

• Covid-19
• immunokromatografi
• PCR
• antikor

COVID-19 Hastalarında İmmunokromatografik Antikor Testi Sonuçları

Abstract

Amaç: COVID-19, pnömonilerle başlayıp kısa sürede pandemiye neden olan bir enfeksiyon hastalığıdır. COVID-19 etkeni olan SARS-CoV-2’ye ait nükleik asitin RT PCR ile saptanması tanıda altın standarttır. SARS-CoV-2 ile enfekte olan hastalarda 7-11 gün sonra antikor cevabı gelişmektedir. Bu çalışmada COVID-19 tanısında immunokromatografik antikor testlerinin yeri araştırılmıştır.
Gereç ve Yöntem: COVID-19 şüphesiyle yatan hastaların COVID-19 antikor çalışılmak üzere Tıbbi Mikrobiyoloji Laboratuvarı’na gönderilen örneklerine ait sonuçlar retrospektif olarak değerlendirildi. Kan örneklerinden serum elde edildikten sonra kolloidal altın bazlı immunokromatografik lateral flow test yöntemi kullanıldı. Hastaların demografik özellikleri ile eş zamanlı bulunan laboratuvar değerleri ve radyoloji bulguları da çalışmaya dahil edildi.
Bulgular: Çalışmaya dahil edilen 98 hastanın 50’sinde (%51) COVID-19 antikor pozitifliği saptandı. PCR pozitifliği bulunan kesin tanı grubundaki 28 hastanın 18’inde (%64,2) COVID-19 antikor pozitifliği mevcuttu. PCR negatifliğine rağmen radyoloji bulgularını karşılayan ön tanı grubundaki 70 hastanın ise 32’sinde (%45,7) COVID-19 antikor pozitifliği vardı. Antikoru pozitif saptanan 50 hastanın 18’inin PCR sonucunun pozitif olduğu görüldü. Otuz iki hasta ise PCR negatifliğine rağmen radyolojik açıdan COVID-19 lehine değerlendirildi.
Sonuç: COVID-19 tanısında altın standart, viral nükleik asitin saptanmasıdır. Epidemiyoloji, bağışık yanıt izlemi, asemptomatik olguların saptanması gibi durumlarda serolojik testlerden yararlanabilir. Serolojinin tanıdaki rolünün tam olarak netleştirilememesi, farklı kitlere ve cihazlara ait duyarlılık ve özgüllük oranlarının bulunması nedeniyle, bu konuda yapılacak çeşitli araştırmalar COVID-19 pandemisinde tanısal süreçlere ışık tutacaktır.

Keywords

• COVID-19
• immunokromatografi
• PCR
• antikor

References

1. 1. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak: Rothan HA et al (J Autoimmun 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433) 2. Molecular immune pathogenesis and diagnosis of COVID-19: Li X, Geng M, Peng Y, Meng L, Lu S. (J Pharm Anal. 2020 Mar 5. doi: 10.1016/j.jpha.2020.03.001)
2. 3. Antbody responses to SARS-CoV-2 n patents of novel coronavrus dsease 2019 Zhao et al. (Cln Infect Ds 28 March 2020; do: 10.1093/cd/caa344)
3. 4. Serologcal mmunochromatographc approach n dagnoss wth SARSCOV-2 nfected COVID-19 patents Pan Y et al. (J Infect 2020 Apr 10. p:S0163-4453(20)30175-4; do: 10.1016/j.jnf.2020.03.051)
4. 5. The Laboratory Dagnoss of COVID-19 Infecton: Current Issues and Challenges Tang YW et al. (J Cln Mcrobol 3 Aprl 2020; do:10.1128/JCM.00512-20)
5. 6. Report from the Amercan Socety for Mcrobology COVID-19 Internatonal Summt, 23 March 2020: Value of Dagnostc Testng for SARS–CoV-2/COVID-19 Patel R et al. (mBo 2020 Mar-Apr; 11(2): e00722-20; do: 10.1128/mBo.00722-20)
6. 7. Hong K.H, Lee S.V, Kim TS, Huh HJ, Lee J,Yeon Kim S, et al. Guidelines for Laboratory Diagnosis of Coronavirus Disease 2019 (COVID-19) in Korea. Annals of Laboratory Medicine.2020; 40(5):351–60.
7. 8. Zitek T. The Appropriate Use of Testing for COVID-19. Western Journal of Emergency Medicine 2020; 21(3):470–72.
8. 9. Conklin, S. E., Martin, K., Manabe, Y. C., Schmidt, H. A., Miller, J., Keruly, M., Klock, E., Kirby, C. S., Baker, O. R., Fernandez, R. E., Eby, Y. J., Hardick, J., Shaw-Saliba, K., Rothman, R. E., Caturegli, P. P., Redd, A. D., Tobian, A. A. R., Bloch, E. M., Benjamin Larman, H., … Laeyendecker, O. (2021). Evaluation of serological SARS-CoV-2 lateral flow assays for rapid point-of-care testing. Journal of Clinical Microbiology, 59(2), 1–10. https://doi.org/10.1128/JCM.02020-20

9. 10. Diagnostic performance of COVID-19 serology assays: Z Zainol Rashid et al. Malays J Pathol.2020 Apr;42(1):13-21.
10. 11. Pan, Y., Li, X., Yang, G., et al (2020). Serological immunochromatographic approach in diagnosis with SARS-CoV-2 infected COVID19 patients. J Infect, doi:10.1016/j.jinf.2020.03.051
11. 12. Lechien , J.R., et al., Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study. Eur Arch Otorhinolaryngol, 2020.
12. 13. Zhao, W., et al., Relation Between Chest CT Findings and Clinical Conditions of Coronavirus Disease (COVID-19) Pneumonia: A Multicenter Study. American Journal of Roentgenology, 2020: p. 1-6.
13. 14. Parasher, A., Saini, V., Saini, A., Barik, R. R., Aggarwal, A., & Khan, J. (2020). A study of the association of leukopenia with disease severity and mortality in patients diagnosed with COVID-19. International Journal of Advances in Medicine, 7(11), 1721. https://doi.org/10.18203/2349-3933.ijam20204526
14. 15. Luo X, Zhou W, Xiaojie Y et al (2020). Prognostic value of C-reactive protein in patients with COVID-19. medRxiv, doi: 10.1101/2020.03.21.20040360.
15. 16. Lippi G, Plebani M (2020). Procalcitonin in patients with severe coronavirus disease 2019 (COVID-19): a metaanalysis. Clin Chim Acta, 505:190-191. doi: 10.1016/j.cca.2020.03.004.
16. 17. Ozen, M., Yilmaz, A., Cakmak, V., Beyoglu, R., Oskay, A., Seyit, M., & Senol, H. (2021). D-Dimer as a potential biomarker for disease severity in COVID-19. American Journal of Emergency Medicine, 40, 55–59. https://doi.org/10.1016/j.ajem.2020.12.023
17. 18. Patel R, Babady E, Theel E, Storch G, Pinsky B, George K, et al. Report from the American Society for Microbiology COVID-19 COVID-19. MBio. 2020;11(2):1-5
18. 19. Chakraborty, D., Kumar, S., Chandrasekaran, N., & Mukherjee, A. (2020). Viral Diagnostics and Preventive Techniques in the Era of COVID-19: Role of Nanoparticles. Frontiers in Nanotechnology, 2(October), 1–7. https://doi.org/10.3389/fnano.2020.588795
19. 20. Zhang W, Du RH, Li B, et al. Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect. 2020;9(1):386-9
20. 21. Wu, J., Tseng, W., Lin, C., Lee, T., & Chung, M. (2020). Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID- 19. The COVID-19 resource centre is hosted on Elsevier Connect, the company ’ s public news and information. Journal of Infection, 81(January), 435–442.