Fluorescence Immunoassay Covid-19 Antigen – Product code: SC-1293-20
The Covid-19 antigen cassette test is an immunofluorescence test for the qualitative detection of Sars-CoV-2 antigens present in the human nasopharynx with the use of the Immunofluorescence Analyzer. For professional in vitro diagnostic use only. The COVID-19 Antigen Cassette Test (Nasopharyngeal Swab) is based on immunofluorescence for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 infection together with clinical history and results of other laboratory tests. The results identify SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally found in swabs of the upper respiratory tract during the acute phase of the infection. Positive results indicate the presence of viral antigens, but a clinical correlation with the patient’s medical history and other diagnostic information is required to determine the infectious state. The positive results do not exclude bacterial infection or co-infections with other viruses. The identified agent may not be the determining cause of the disease. Negative results do not exclude SARS-CoV-2 infection and should not be used as the sole basis for therapy or other patient management decisions, including infection control. Negative results should be evaluated at the same time as recent exposures, patient history and in the presence of clinical signs and symptoms compatible with COVID-19, as well as confirmed by a molecular test, if necessary for patient management. The new coronavirus (SARS-CoV-2) belongs to the β genus. COVID-19 is an acute respiratory infectious disease. It mainly affects humans. Patients infected with the new coronavirus are currently the main source of infection; even asymptomatic infected individuals can be a source of infection. According to the latest epidemiological studies, the incubation period ranges from 1 to 14 days, and is mainly concentrated between the 3rd and 7th day. The most common manifestations include fever, fatigue, and dry cough. Nasal congestion, runny nose, sore throat, myalgia, and diarrhea are also present in some cases. The COVID-19 Antigen Cassette Test (Nasopharyngeal Swab) is a membrane-based, qualitative fluorescence immunoassay for the detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal swab samples. The test line area is coated with SARS-CoV-2 nucleocapsid protein antibody. During testing, the sample reacts with the fluorescent beads coated with SARS-CoV-2 nucleocapsid protein antibody on the device. The compound then migrates upwards by capillary action and reacts with the SARS-CoV-2 nucleocapsid protein antibody in the test line area. The immunofluorescence analyzer identifies the fluorescence signal value of a specific area and calculates the result of the SARS-CoV-2 nucleocapsid protein antigen in the sample according to the algorithm on the ID card.