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The Rapid Response COVID-19 IgG/IgM Test Cassette is a rapid, qualitative test for the detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG antibodies in human whole blood, serum, or plasma samples, as an aid in the diagnosis of COVID-19 disease. Interpretation of test results are positive (two lines or three lines) and negative (one line). Available for sale to healthcare professionals in United States and Europe (CE marked). ANVISA approval for diagnostic use is 8.01.025-1