ELISA Kits COVID-19 IgM

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 IgM ELISA Kit is intended for qualitative measurement of the COVID-19 IgM antibody in serum. This assay utilizes the “IgM capture” method on microplate based enzyme-linked immunosorbent assay. IgM is the first immunoglobulin to be produced in response to an antigen and will be primarily detectable during the early onset of the disease. PRINCIPLE OF THE TEST Assay controls and samples are added to the microtiter wells of a microplate that was coated with a anti-human IgM specific antibody. After the first incubation period, the unbound protein matrix is removed with a subsequent washing step. A horseradish peroxidase (HRP) labeled recombinant COVID-19 antigen is added to each well. After an incubation period, an immunocomplex of "Anti-hIgM antibody - human COVID-19 IgM antibody - HRP labeled COVID-19 antigen" is formed if there is novel coronavirus IgM antibody present in the tested materials. The unbound tracer antigen is removed by the subsequent washing step. HRP-labeled COVID-19 antigen tracer 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 antigen bound to the coronavirus IgM of the microtiter well is proportional to the amount of the coronavirus IgM antibody level in the tested materials. MATERIALS AND REAGENTS COVID-19 IgM 96-wells microplate COVID-19 IgM Sample Diluent HRP Labeled COVID-19 Antigen ELISA Wash Concentrate ELISA HRP Substrate ELISA Stop Solution COVID-19 IgM Negative Control COVID-19 IgM 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%. Class Specificity This assay does not show any cross reaction to IgG. 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) SENSITIVITY AND SPECIFITY The diagnostic sensitivity is 45%. The diagnostic specificity is 100%. The negative predictive value is 83.1%. The positive predictive value is 100%. CE-IVD certificated