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

Qualitative detection and differentiation of IgM and IgG antibodies  against SARS-CoV-2 in human serum, plasma, and venous whole  blood (sodium heparin, potassium EDTA, and sodium citrate).

For professional in vitro diagnostic use only.

For use under an Emergency Use Authorization Only.


  • Description
  • Specifications
  • INTENDED USE】 

    The RightSignTM 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 RightSignTM 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 RightSignTM 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 RightSignTM 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】 

    Cat. No.

    Product

    Specimen

    Format

    Pack

    INGM-MC42

    RightSignTMCOVID-19 IgG/IgM Rapid Test Cassette

    WB/S/P

    Cassette

    25T


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