Submarine 2010 wiki12/9/2023 ![]() ![]() Currently available immunochromatographic COVID-19 antibody testing gives rise to qualitative detection thus accounting for false-negative results in clinical practice. Recently, some antibody-test kits for SARS-CoV-2 have been made available for research however, their performance is poor, and they generate unreliable and low-quality results 17, 23, 24, 25. Because the relationship between antibody levels and clinical response is still unclear 20, 21, 22, it is necessary to identify the SARS-CoV-2 protein, which can be used as a target in diagnostic tests with a better diagnostic performance. Additionally, several methods have been developed for measuring the titers of antibodies against SARS-CoV-2 proteins, such as nucleocapsid proteins and receptor proteins (Spike protein, S1 domain, and receptor binding domain) 15, 16, 17, 18, 19. However, it has been reported that in the early stage of SARS-CoV-2 infection IgG levels increase rather than IgM levels 13, 14. It has been reported that IgM levels increase early after infection in common viral infections, as well as in COVID-19, followed by an increase in IgG levels 12. ![]() Blood-based antibody diagnostic analysis commonly assesses IgG and IgM titers 9, 10, 11. More recently, antigen testing has also been used, although it is slightly less sensitive and precise than PCR testing 7.Īntibody testing aimed at detecting SARS-CoV-2-related immunity of patients is believed to be associated with the clinical history of the infected patients and their virus-neutralizing immune response 8. In such circumstances, developing a high-performance and cost-effective diagnostic tool for COVID-19 is a high priority.Ĭurrently, polymerase chain reaction (PCR) testing based on the detection of the SARS-CoV-2 genome has been widely employed in clinical settings and used as a gold-standard to confirm positive and negative infections 5, 6. Moreover, SARS-CoV-2 may persist in some convalescent COVID-19 survivors, and its infection could continue to recur, causing a continued pandemic. However, no specific therapeutic agents for COVID-19 are currently available. SARS-CoV-2 causes severe, acute-and in some cases-fatal coronavirus disease in humans, named COVID-19, and is considered a global public threat 1, 2, 3, 4. The epidemic triggered by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that originated in China has rapidly spread worldwide. This highly quantitative, reproducible assay system with high clinical performance may help analyze temporal serological/immunological profiles of SARS-CoV-2 infection and SARS-CoV-2 vaccine effectiveness. Clinical severity upon admission was not correlated with IgG or IgM levels. Mean antibody levels were > 10 times that in negative samples upon admission and > 100 times that at convalescent periods. Detection accuracy was 98.3% and 93.3% for IgG and IgM against spike proteins and 100% and 71.7% for IgG and IgM against nucleocapsid proteins, respectively. The system showed high quantification accuracy (range, 10 2), high reproducibility (within 5%), and no cross-reaction between SARS1- and MERS-S proteins. Assay performance was evaluated using serum samples from the SARS-CoV-2-infected patients and 500 SARS-CoV-2-negative serum samples collected before the emergence of SARS-CoV-2. Quantification accuracy and reproducibility were evaluated using serially diluted samples from 60 SARS-CoV-2-infected patients. The system was based on the high-sensitivity chemiluminescence enzyme immunoassay (HISCL) platform and detects IgG and IgM specific to SARS-CoV-2 spike and nucleocapsid proteins. Herein, we developed a diagnostic test that detects SARS-CoV-2 IgG and IgM with high quantitativeness and reproducibility and low interference. The quantitative range and reproducibility of current serological tests for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) are not optimized.
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