GENERAL INFORMATION
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 IgG test is a qualitative and quantitative immunoassay for the detection of human IgG 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. ELISA agile SARS-CoV-2 IgG can additionally be used for epidemiological studies.
This quantitative test setup also offers the possibility to screen for potential donors with protective antibodies whose convalescent plasma can be used for therapeutic purposes.
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
IgG 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 IgG 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 IgG, Adenovirus IgG, Influenza A Virus IgG and Epstein-Barr Virus EA IgG. No cross reactivity could be detected for the SERION ELISA agile SARS-CoV-2 IgG.
The kit is CE-IVD marked and is included in the database of the Joint Research Center of the European Commission: SERION ELISA agile SARS-CoV-2 IgG Kit