COVID-19 rapid test SC-1309-20

for antigensbloodimmunofluorescence

Immunofluorescence test for the qualitative detection of IgG and IgM antibodies to Sars-CoV-2 present in human whole blood, serum or plasma with the use of the Immunofluorescence Analyzer as an aid in the diagnosis of Covid-19 infection. For professional in vitro diagnostic use only. The Covid-19 IgG/IgM Cassette Test is an immunofluorescence test for the qualitative detection of Sars-CoV-2 IgG and IgM antibodies in whole blood, serum or plasma samples. The Covid-19 IgG/IgM test is an aid in diagnosing patients with suspected Sars-CoV-2 infection along with medical history and other laboratory test results. COVID-19 IgG/IgM test results should not be used as the sole basis for diagnosis. The results detect SARS-CoV-2 antibodies. The IgM antibodies of SARS-COV-2 are generally detectable in the blood several days after the onset of infection, even if the levels during the infection are not well determined. The IgG antibodies of SARS-COV-2 become detectable later in the course of the infection. Positive results for both IgG and IgM may occur following infection and indicate acute or recent infection. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID-19 IgG/IgM test in the early stages of infection is not known. False positive results for IgG and IgM antibodies may occur due to cross reactivity with pre-existing antibodies or other possible causes. At the moment, the duration of the persistence of IgM and IgG antibodies following infection is not known.