3940 – GA CoV-2 IgG+

The GA CoV-2 IgG + is a semi-quantitative immunoassay for the determination of IgG antibodies against immunodominant antigens (Spike Glycoprotein 1, Spike Glycoprotein 2, Nucleocapsid Protein) of SARS-Coronavirus 2 (SARS-CoV-2) in human serum and plasma. The GA CoV-2 IgG is intended as an as an aid for immune status determination to SARS-Coronavirus 2 (SARS-CoV-2) in conjunction with other clinical and laboratory findings as well as for confirmation of positive SARS-CoV-2 IgG antibody test results in the first screening.

The severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) was first identified in Wuhan, Hubei, China, as the causative agent of COVID-19 (corona virus disease 2019), a severe acute respiratory distress syndrome. Global spreading of the virus resulted in the COVID-19 pandemic. The virus is primarily transmitted via infected aerosols and respiratory droplets. Transmission via contaminated surfaces is also possible. The symptoms of COVID‑19 may manifest after an incubation period of 1 to 14 days post exposure to the virus and vary widely. In addition to clinically unapparent infections, predominantly flu-like symptoms with fever, cough, headache, fatigue, breathing difficulties as well as loss of smell and taste in combination with mild pneumonia have been described in the majority of cases. In some cases, however, courses with life-threatening severe acute respiratory syndromes manifest. In mild cases, the symptoms usually subside within two weeks. Serious diseases may last up to three to six weeks. Some patients continue to suffer from a range of different long COVID effects even months after recovery. As the clinical symptoms of COVID-19 are very unspecific, laboratory diagnosis is of enormous importance, in particular to identify acute infected individuals that may spread the virus to their environment. Direct and indirect detection methods have been made available. In the first days after infection, direct pathogen detection methods to determine viral antigens or RNA from sputum, tracheal secretion, bronchial lavage (BAL) or nasopharyngeal swabs are the methods of choice. Indirect pathogen detection methods for the serological demonstration of SARS-CoV-2 specific antibodies supplement the direct methodologies to support the diagnosis of COVID-19.

The ELISA (Enzyme Linked Immunosorbent Assay) is an immunoassay for the determination of specific antibodies. The strips of the microtiter plate are coated with test-specific antigens. If antibodies are present in the patient´s sample, they bind to the antigens. A secondary antibody conjugated with the enzyme peroxidase detects the generated immune complex. A colorless substrate is converted into the colored product. The signal intensity of the reaction product is proportional to the antibody activity in the sample. After stopping the signal intensity of the reaction product is measured photometrically.

The immunoassay is designed for manual professional in vitro diagnostic use.