ELISA Kits COVID-19 IgG

Severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) is the name given to the new coronavirus that originated in 2019 and is the causative agent of COVID-19 (the disease caused by the SARS-CoV-2 virus). The virus was originally known as the 2019-nCoV nomenclature. SARS-CoV-2 is a new coronavirus strain that has not been previously identified in humans. The genome of these viruses consists of single-stranded RNA protected by two protein coatings - nucleocapsid and capsid. Its genetic characteristics are significantly different from SARS-CoV and MERS-CoV. EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit is intended for qualitative measurement of the human anti-COVID-19 IgG antibody in serum. This assay utilizes t he method of microplate based indirect enzyme-linked immunosorbent assay . PRINCIPLE OF THE TEST Assay controls and diluted serum samples are added to the microtiter wells of a microplate that was coated with COVID-19 recombinant full length nucleocapsid protein. After the first incubation period, the unbound protein matrix is removed with a subsequent washing step. A horseradish peroxidase (HRP) labeled polyclonal goat anti-human IgG tracer antibody is added to each well. After an incubation period, an immunocomplex of "COVID-19 recombinant antigen – human anti-COVID-19 IgG antibody - HRP labeled anti human IgG tracer antibody" is formed if there is specific coronavirus IgG antibody present in the tested specimen. The unbound tracer antibody is removed by the subsequent washing step. HRP tracer antibody bound to the well is then incubated with a substrate solution in a timed reaction and then measured in a spectrophotometric microplate reader. The enzymatic activity of the tracer antibody bound to the anti-COVID-19 IgG on the wall of the microtiter well is proportional to the amount of the anti-COVID-19 IgG antibody level in the tested specimen. MATERIALS AND REAGENTS COVID-19 antigen coated microtiter plate COVID-19 IgG Sample Diluent HRP labeled Anti-human IgG Tracer Antibody ELISA Wash Concentrate ELISA HRP Substrate ELISA Stop Solution COVID-19 IgG Negative Control COVID-19 IgG Positive Control PERFORMANCE CHARACTERISTICS Limit of Detection No international standardized units are available for COVID-19. A positive sample was serially diluted and the limit of detection was determined to be not higher than 5 U/mL. Repeatability The assay control is tested in 10 replicates with a CV of OD values less than 15%. Reproducibility Three lots were tested with the same samples 10 times with a CV less than 20%. Cross-Reactivity Panels were studied with a minimum of five confirmed disease state samples. No interference was observed for the following disease or infectious agents: Anti-influenza A Anti-influenza B Hepatitis C (HCV) Antinuclear Antibodies (ANA) Respiratory Syncytial Virus (RSV) Class Specificity This assay does not show any cross reaction to IgМ. SENSITIVITY AND SPECIFITY The diagnostic sensitivity is 100%. The diagnostic specificity is 100%. The negative predictive value is 100%. The positive predictive value is 100%. CE-IVD certificated