RightSign COVID-19 IgG/IgM Rapid Test Cassette (EUA)

【INTENDED USE】 

The RightSign^TM COVID-19 IgG/IgM Rapid Test Cassette  is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in in human venous whole blood (sodium heparin, EDTA, and sodium citrate), serum or plasma (sodium heparin, potassium EDTA and sodium citrate). The RightSign^TM COVID-19 IgG/IgM Rapid Test Cassette is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The RightSign^TM COVID-19 IgG/IgM Rapid Test Cassette should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C 263a, that meet the requirements to perform moderate or high complexity tests.

【SUMMARY】  

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

The RightSign^TM COVID-19 IgG/IgM Rapid Test Cassette is a rapid test that utilizes a combination of SARS-COV-2 antigen coated colored particles for the detection of IgG and IgM antibodies to SARS-COV-2 in human whole blood, serum or plasma.

【DIRECTIONS FOR USE】  

【Order Information】