Sars-Cov-2 Infection Screening Using Two Serological Testing Methods

Abstract

The challenges associated with adequate deployment of nucleic acid amplification tests (NAATs) in developing countries underscores the important role of simple but sensitive and specific serological testing kits in COVID-19 diagnosis. Presently, there are a number of point-of-care tests for Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2) screening. However, the reliability of these test kits is poorly documented and hence, needs to be ascertained. This study was therefore designed to determine the sensitivity and specificity of two serological test kits for COVID-19 screening with the view to providing necessary information on the suitability of their deployment as routine test kits for SARS-CoV-2 in Nigeria. Forty-seven (47) asymptomatic adults who had been tested for SARS-CoV-2 with the real-time reverse-transcriptase polymerase-chain reaction (RT-PCR) were enrolled into this study. Blood samples were obtained for qualitative determination of serum IgM and IgG antibodies to the S-antigen of SARS-CoV-2 using a commercially available IgM and IgG Rapid Diagnostic Test (RDT) and enzyme linked immunosorbent assay (ELISA). The association between the test kits (ELISA and RDT) and PCR in diagnosing COVID-19 was determined using the Fisher’s Exact test at P<0.05. The sensitivity and specificity of the test kits were determined using ROC while the Positive Predictive Value (PPV), Negative Predictive Value (NPV), Positive Likelihood Ratio (PLR), Negative Likelihood Ratio (NLR), Diagnostic Odds Ratio (DOR) and accuracy were calculated as appropriate. Twenty-eight (59.6%) of the study participants had positive PCR result. ELISA and RDT identified 20 (42.6%) and 13 (27.7%) participants respectively as having anti- SARS COV-2 specific antibodies. ELISA had a better sensitivity performance, NPV, PLR, DOR and accuracy than the RDT while the RDT had a better specificity performance than ELISA. The proportion of participants with anti-SARS-CoV-2 IgM antibody identified using ELISA was significantly higher compared with RDT. In contrast, the proportion of participants with positive anti- SARS COV-2 IgG antibody identified using RDT was significantly higher compared with ELISA. ELISA has a better sensitivity for detecting anti-SARS-CoV-2 Spike-protein specific antibodies than the RDT. However, combination of RDT and ELISA for the detection of anti-SARS-COV-2 antibodies might be useful for population COVID-19 screening

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References

Ai, T., Yang, Z., Hou, H., Zhan, C., Chen, C., Lv, W., Tao, Q., Sun, Z., and Xia, L. (2020). 'Correlation of Chest CT and RT-PCR Testing for Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases', Radiology, 296: E32-e40.

FDA. 2020. 'Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (2020). Available at: https://www.fda.gov/regulatory-information/search-fdaguidance-documents/policy-coronavirus-disease-2019tests-during-public-health-emergency-revised. Accessed: 08 December, 2020.

Jacofsky, D., Jacofsky, E. M., and Jacofsky, M. (2020). 'Understanding Antibody Testing for COVID-19', J Arthroplasty, 35: S74-s81.

La Marca, A., Capuzzo, M., Paglia, T., Roli, L., Trenti, T., and Nelson, S. M. (2020). 'Testing for SARS-CoV-2 (COVID-19): a systematic review and clinical guide to molecular and serological in-vitro diagnostic assays', Reproductive biomedicine online.

Liu, X., Wang, J., Xu, X., Liao, G., Chen, Y., and Hu, C. H. (2020). 'Patterns of IgG and IgM antibody response in COVID-19 patients', Emerg Microbes Infect, 9: 1269-1274.

Long, Q. X., Liu, B. Z., Deng, H. J., Wu, G. C., Deng, K., Chen, Y. K., Liao, P., Qiu, J. F., Lin, Y., Cai, X. F., Wang, D. Q., Hu, Y., Ren, J. H., Tang, N., Xu, Y. Y., Yu, L. H., Mo, Z., Gong, F., Zhang, X. L., Tian, W. G., Hu, L., Zhang, X. X., Xiang, J. L., Du, H. X., Liu, H. W., Lang, C. H., Luo, X. H., Wu, S. B., Cui, X. P., Zhou, Z., Zhu, M. M., Wang, J., Xue, C. J., Li, X. F., Wang, L., Li, Z. J., Wang, K., Niu, C. C., Yang, Q. J., Tang, X. J., Zhang, Y., Liu, X. M., Li, J. J., Zhang, D. C., Zhang, F., Liu, P., Yuan, J., Li, Q., Hu, J. L., Chen, J., and Huang, A. L. (2020). 'Antibody responses to SARS-CoV-2 in patients with COVID-19', Nat Med, 26: 845-848.

Molinaro, A. M. (2015). 'Diagnostic tests: how to estimate the positive predictive value', Neuro-Oncology Practice, 2: 162-166.

Özçürümez, M. K., Ambrosch, A., Frey, O., Haselmann, V., Holdenrieder, S., Kiehntopf, M., Neumaier, M., Walter, M., Wenzel, F., Wölfel, R., and Renz, H. (2020). 'SARS-CoV-2 antibody testing-questions to be asked', J Allergy Clin Immunol, 146: 35-43.

Pereira, P. (2016). 'Evaluation of rapid diagnostic test performance', Proof and Concepts in Rapid Diagnostic Tests and Technologies: 139-161.

Racine, R., and Winslow, G. M. (2009). 'IgM in microbial infections: taken for granted?', Immunol Lett, 125: 79-85.

Tang, M. S., Hock, K. G., Logsdon, N. M., Hayes, J. E., Gronowski, A. M., Anderson, N. W., and Farnsworth, C. W. (2020). 'Clinical Performance of Two SARS-CoV-2 Serologic Assays', Clin Chem, 66: 1055-1062.

Trevethan, R. (2017). 'Sensitivity, Specificity, and Predictive Values: Foundations, Pliabilities, and Pitfalls in Research and Practice', Front Public Health, 5: 307.

Wang, J., Chen, C., Li, Q., Cai, P., Wang, Z., and Wang, L. (2020). 'COVID-19 confirmed patients with negative antibodies results', BMC Infectious Diseases, 20: 698.

Weissleder, R., Lee, H., Ko, J., and Pittet, M. J. (2020). 'COVID-19 diagnostics in context', Sci Transl Med, 12.

WHO. (2020a). "COVID-19 immune response." In.: World Health Organization.

———. (2020b). "Laboratory testing for coronavirus disease (COVID-19) in suspected human cases.

Wölfel, R., Corman, V. M., Guggemos, W., Seilmaier, M., Zange, S., Müller, M. A., Niemeyer, D., Jones, T. C., Vollmar, P., Rothe, C., Hoelscher, M., Bleicker, T., Brünink, S., Schneider, J., Ehmann, R., Zwirglmaier, K., Drosten, C., and Wendtner, C. (2020). 'Virological assessment of hospitalized patients with COVID-2019', Nature, 581: 465-469.

Yang, Y., Yang, M., Shen, C., Wang, F., Yuan, J., Li, J., Zhang, M., Wang, Z., Xing, L., and Wei, J. (2020). 'Laboratory diagnosis and monitoring the viral shedding of 2019-nCoV infections', MedRxiv.

Zhang, W., Du, R., Li, B., Zheng, X., Yang, X. L., Hu, B., Wang, Y., Xiao, G., Yan, B., and Shi, Z. "Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect. 2020; 9 (1): 386-9." In.

Zhao, J., Yuan, Q., Wang, H., Liu, W., Liao, X., Su, Y., Wang, X., Yuan, J., Li, T., Li, J., Qian, S., Hong, C., Wang, F., Liu, Y., Wang, Z., He, Q., Li, Z., He, B., Zhang, T., Fu, Y., Ge, S., Liu, L., Zhang, J., Xia, N., and Zhang, Z. (2020). 'Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019', Clin Infect Dis, 71: 2027-2034.

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