3987 – GA CoV-2 Antigen Rapid Nasal

The GA CoV-2 Antigen Rapid Nasal is a qualitative immunoassay for the determination of SARS-Coronavirus 2 (COVID-19) antigen in human nasal specimen. The GA CoV-2 Antigen Rapid Nasal is intended as an aid in the diagnosis of COVID-19 in conjunction with other clinical and laboratory findings.

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.

Rapid immunochromatographic assays are widely used for the determination of specific antigens. A SARS-CoV-2 antibody is coated in the area of the test line T. During the test, the sample reacts with the particles coated with SARS-CoV-2 antibodies. This complex migrates through the membrane by capillary action and reacts with the SARS-CoV-2 antibody in the test line region. If the sample contains SARS-CoV-2 antigens, a colored line appears in the test line region as a result. If the sample contains no antigens against SARS-CoV-2, no colored line appears in the test line region, indicating a negative result. A second colored line in the control line region C is used as a procedural control, which appears when the sample volume is applied correctly and the membrane is sufficiently moistened..

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