Development of an ELISA Using Recombinant Chimeric SM Protein for Serological Detection of SARS-CoV-2 Antibodies
Nakhanova G. Chervyakova O. Shorayeva K. Issabek A. Moldagulova S. Zhunushov A. Ulankyzy A. Zhakypbek A. Omurtay A. Nakhanov A. Absatova Z. Shayakhmetov Y. Jekebekov K. Baiseit T. Kerimbayev A.
February 2026Multidisciplinary Digital Publishing Institute (MDPI)
Methods and Protocols
2026#9Issue 1
The emergence and spread of coronavirus infections have created a necessity to develop serological methods for assessing population immunity. The enzyme-linked immunosorbent assay (ELISA) remains one of the most accessible and informative approaches for these purposes. The choice of recombinant proteins plays an important role in the sensitivity and specificity of the test system, and in this regard, the creation of a domestic ELISA based on the chimeric SM protein to the SARS-CoV-2 virus is relevant. In this work, a recombinant chimeric SM protein expressed in the E. coli system and purified using metal-affinity chromatography on Ni-NTA agarose was constructed and presented for the first time. An ELISA test system was developed and tested using panels of positive and negative sera, including samples obtained before the COVID-19 pandemic. The obtained sensitivity (90.48%) and specificity (93.65%) indicators with a ROC curve AUC = 0.9623 (OD450 = 0.213) indicate the diagnostic accuracy of the test system. The positive diagnostic ratio (LR+) = 14.25.0 indicates the reliability of a positive result. The domestically developed ELISA test system can be used for serological monitoring and assessment of the immune status of the population.
cloning , enzyme-linked immunosorbent assay , expression , purification , recombinant chimeric protein
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Research Institute for Biological Safety Problems LLP, National Holding QazBioPharm JSC, Almaty, 080409, Kazakhstan
Institute of Biotechnology, National Academy of Sciences of the Kyrgyz Republic, Bishkek, 720071, Kyrgyzstan
Research Institute for Biological Safety Problems LLP
Institute of Biotechnology
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