Published date: Jul 09 2020

Journal Title: Sudan Journal of Medical Sciences

Issue title: SJMS Special Issue 2020: Competing with COVID-19 in Sudan

Pages: 71-79

DOI: 10.18502/sjms.v15i5.6969

Sahar Elderdiri Gafar Osmansahardirdery@yahoo.comAssistant professor of Histopathology and Cytology at Alfajr College of Science and Technology

Ehab Mohammed Elmadenah Mohammed Mohammed Ahmedeelmadenah@gmail.com1. Department of Hematology, Faculty of Medical Laboratory Science, Dongola University, Aldabbah, Sudan.

Nazik Elmaliaka Hussainnazikhusain@gmail.comDepartment of Pathology, Faculty of Medicine, Omdurman Islamic University, Khartoum, Sudan

Abstract:

Background: The World Health Organization recommends molecular tests (PCR) to the diagnosis of COVID-19, which detect the (SARS-CoV2) virus RNA. However, these tests are expensive and give a high negative result. There were urgent medical and public health needs for early diagnosis and treatment to minimize the spread of COVID-19. This review aimed to summarize known to date information about the latest research progress of the sensitivity and specificity of rapid combined IgM/IgG antibody test to diagnose the pandemic novel coronavirus.

Methods: The literature search was conducted using PubMed, Google Scholar, Science Direct, supplemented by (Web of Science electronic databases), with the search term (COVID19 or COVID-19, novel coronavirus, SARS CoV-2 or SARS CoV2, Rapid antibody test, IgM/IgG, sensitivity, specificity).

Results: The review included eight clinical studies for a total of 782 patients with COVID-19 and 631 healthy control. The sensitivity and specificity of Gold Chromatography Immuno-Assays (GCIAs) IgM/IgG rapid test vary greatly among published studies. The IgM/IgG sensitivity ranged from 73.9 to 89.3% in 6/8 (75%) studies and the IgM/IgG specificity ranged from 88.9 to 100% in the eight (100%) reviewed studies. The pooled data revealed that the average of sensitivity and specificity was 70% and 94.5%, respectively. They agreed on its simplicity, fastness, and fewer requirements.

Conclusion: The GCIAs IgM/IgG rapid tests are simply fast and safe. Besides their short turnaround time, no specific equipment or skilled technicians’ requirements, they can serve as a rapid diagnostic test of RT-PCR-negative symptomatic patients and screening of SARS CoV-2 carriers. It cannot take the place of PCR, but the huge lab diagnosis pressure can be greatly relieved and more research is needed to detect its reliability in limited-resource settings. 

Keywords: COVID-19, Rapid Test, IgM/IgG, Sensitivity, Specificity, Limited-resource.

1. Fehr AR, Perlman S. Coronaviruses: An Overview of Their Replication and Pathogenesis. Humana Press. 2015;1282(1):1–23.
2. Shereen MA, Khan S, Kazmi A, Bashir N, Siddique R. COVID-19 infection: Origin, transmission, and characteristics of human coronaviruses. J Adv Res. 2020;24:91–8.
3. World Health Organization. Laboratory testing for coronavirus disease 2019 (COVID-19) in suspected human cases. World Heal Organ. 2020;2019(March):1–7.
4. Park S. Epidemiology, virology, and clinical features of severe acute respiratory syndrome - coronavirus-2 (SARS-CoV-2; Coronavirus Disease-19). Clin Exp Pediatr. 2020;63(4):119–24.
5. World Health Organization. Coronavirus disease 2019 (COVID-19)Situation Report –99. WHO. 2020;14(6):1–12.
6. Guo YR, Cao QD, Hong ZS, Tan YY, Chen SD, Jin HJ, 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.
7. Zhang J, Wang S, Xue Y. Fecal specimen diagnosis 2019 novel coronavirus–infected pneumonia. J Med Virol. 2020;7(February):8–10.
8. Rasmussen SA, Smulian JC, Lednicky JA, Wen TS, Jamieson DJ. Coronavirus Disease 2019 (COVID-19) and Pregnancy: What obstetricians need to know. Am J Obstet Gynecol. 2020;2019:1–12.
9. Singhal T. A Review of Coronavirus Disease-2019 (COVID-19). Indian J Pediatr. 2020;87(4):281–6.
10. Lovato A, de Filippis C. Clinical Presentation of COVID-19: A Systematic Review Focusing on Upper Airway Symptoms. Ear Nose Throat J. 2020;1–3.
11. Khedmat L. New Coronavirus (2019-nCoV): An Insight Toward Preventive Actions and Natural Medicine. Int Travel Med Cent Iran. 2020;8(1):44–5.
12. World Health Organization. Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19). WHO. 2020;2019(February):16–24.
13. Zhong BL, Luo W, Li HM, Zhang QQ, Liu XG, Li WT, et al. Knowledge, attitudes, and practices towards COVID-19 among Chinese residents during the rapid rise period of the COVID-19 outbreak: a quick online cross-sectional survey. Int J Biol Sci. 2020;16(10):1745–52.
14. Mardani R, Ahmadi Vasmehjani A, Zali F, Gholami A, Mousavi Nasab SD, Kaghazian H, et al. Laboratory Parameters in Detection of COVID-19 Patients with Positive RT-PCR; a Diagnostic Accuracy Study. Arch Acad Emerg Med. 2020;8(1):43.
15. Chen X, Yang Y, Huang M, Liu L, Zhang X, Xu J, et al. Differences between COVID-19 and suspected then confirmed SARS-CoV-2-negative pneumonia: a retrospective study from a single center. J Med Virol. 2020;1–2.
16. Udugama B, Kadhiresan P, Kozlowski HN, Malekjahani A, Osborne M, Li VYC, et al. Diagnosing COVID-19: The Disease and Tools for Detection. Am Chem Soc. 2020;1–14.
17. Tahamtan A, Ardebili A. Real-time RT-PCR in COVID-19 detection: issues affecting the results. Expert Rev Mol Diagn. 2020;(April):1–2.
18. Li Y, Xia L. Coronavirus Disease 2019 (COVID-19): Role of Chest CT in Diagnosis and Management. Am J Roentgenol. 2020;(June):1–7.
19. Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395(10229):1054–62.
20. Lippi G, Plebani M. The critical role of laboratory medicine during coronavirus disease 2019 (COVID-19) and other viral outbreaks. Clin Chem Lab Med. 2020;(March):39–45.
21. Wang B, Wang L, Kong X, Geng J, Xiao D, Ma C. Long-term Coexistence of Severe Acute Respiratory Syndrome Coronavirus 2 ( SARS-CoV-2 ) with Antibody Response in Coronavirus Disease 2019 ( COVID-19 ) Patients. MedRxiv. 2020;1–13.
22. Miodrag Stojanovic, Marija Apostolovic, Dijana Stojanovi, Zoran Miloševic, Aleksandra Toplaovi, Vesna Miti Lakušic MG. Understanding sensitivity, specificity and predictive values. Vojnosanit Pregl. 2014;71(12):1062–5.
23. Long Q, Liu B, Deng H, Wu G, Deng K, Chen Y, et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Clin Pract Nephrol. 2020;(April):1–15.
24. Li Z, Yi Y, Luo X, Xiong N, Liu Y, Li S, et al. Development and Clinical Application of A Rapid IgM‐IgG Combined Antibody Test for SARS‐CoV‐2 Infection Diagnosis. J Med Virol. 2020;(February):1–17.
25. Hoffman T, Nissen K, Krambrich J, Rönnberg B, Akaberi D, Esmaeilzadeh M, et al. Evaluation of a COVID-19 IgM and IgG rapid test; an efficient tool for assessment of past exposure to SARS-CoV-2. Infect Ecol Epidemiol. 2020;10(1):4–6.
26. Cassaniti I, Novazzi F, Giardina F, Salivaro F, Sachs M, Perlini S, et al. Performance of VivaDiagTM COVID-19 IgM/IgG Rapid Test is inadequate for diagnosis of COVID-19 in acute patients referring to emergency room department. J Med Virol. 2020;march:1–4.
27. Dohla M, Boesecke C, Schulte B, Diegmann C, Sib E, Richter E, et al. Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity. Public Health. 2020;(January):1–3.
28. Ying L, Yue-ping L, Bo D, Feifei R, Yue W, Jinya D, et al. Diagnostic Indexes of a Rapid IgG/IgM Combined Antibody Test for SARS-CoV-2. MedRxiv. 2020;(March):1–13.
29. Xiang J, Yan M, Li H, Liu T, Lin C, Huang S, et al. Evaluation of Enzyme-Linked Immunoassay and Colloidal Gold- Immunochromatographic Assay Kit for Detection of Novel Coronavirus (SARS-Cov-2) Causing an Outbreak of Pneumonia (COVID-19). medRxiv. 2020;(Feb):1–13.
30. Perez Garcia F, Perez-Tanoira R, Romanyk J, Arroyo T, Gomez-Herruz P, Cuadros-Gonzalez J. Rapid diagnosis of SARS-CoV-2 infection by detecting IgG and IgM antibodies with an immunochromatographic device: a prospective single-center study. MedRxiv. 2020;(April):1–16.
31. Lassaunière R, Frische A, Harboe ZB, Nielsen ACY, Fomsgaard A, Karen A, et al. Evaluation of nine commercial SARS-CoV-2 immunoassays. medRxiv. 2020;(April):1–15.

32. Wang Wenling, Xu Y, Gao R, Lu R, Han K, Wu G, et al. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA - J Am Med Assoc. 2020;(March):2–3.
33. Ren X, Liu Y, Chen H, Liu W, Guo Z, Zhang Y, et al. Application and Optimization of RT-PCR in Diagnosis of SARS-CoV-2 Infection. Lancet. 2020;(Feb):1–22.
34. Rodolfo C, Luz PM, Wakimoto MD, Veloso VG, Grinsztejn B, Perazzo H. COVID-19: a meta-analysis of diagnostic test accuracy of commercial assays registered in Brazil. Brazilian J Infect Dis. 2019;(April):1–13.
35. Denis M, Vandeweerd V, Verbeke R, Version: DV der V. COVID-19 Overview of information available to support the development of medical countermeasures and interventions against COVID-19. Transdiscipl Insights Living Pap. 2020;(April):1–157.