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ELISA Kits SARS-CoV-2 IgA

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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 ELISA agile SARS-CoV-2 IgА test is a qualitative and quantitative immunoassay for the detection of human IgA antibodies in serum or plasma directed against SARS-CoV-2. The kit is recommended to support in the diagnosis of COVID-19 and as a complement to direct pathogen detection. PRINCIPLE OF THE TEST The test strips of the SERION ELISA agile microtiter plates are coated with specific antigens of the pathogen of interest. The diluted patient samples are incubated in the coated wells. The specific antibodies present in positive samples bind to the antigens and are detected with alkaline phosphatase-labelled secondary antibodies. This enzyme catalyzes the conversion of the colorless substrate p-nitrophenyl phosphate into the colored product p-nitrophenol. The signal intensity of the reaction product is proportional to the antibody concentration in the sample and is measured photometrically IgА Antibody Profile PERFORMANCE CHARACTERISTICS Sensitivity and Specificity To determine the diagnostic performance of the SERION ELISA agile SARS-CoV-2 IgA and IgG immunoassays, 138 resp. 136 blood donor sera, 134 sera from patients with suspected COVID-19 infection and 13 EQAs samples were evaluated against the corresponding commercially available ELISAs of a competitor. Precision Cross-reactivity The cross-reactivity of SERION ELISA agile SARS-CoV-2 IgA was evaluated in a study with 9 resp. 10 sera each containing potentially cross-reactive antibodies and therefore tested positive for other corona viruses, Epstein-Barr Virus VCA IgM, Adenovirus IgA and Influenza A Virus IgA. No cross reactivity could be detected for the SERION ELISA agile SARS-CoV-2 IgA. CE-IVD certificated

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