Details
PROPOSED USE
The 2019-nCoV IgG Rapid Test Kit (Whole Blood/Serum/Plasma) is a planar flow immunochromatographic method for the qualitative detection of IgG antibodies to 2019-nCoV in whole blood, serum and plasma from patients infected with COVID-19 by a healthcare professional. The purpose of the COVID-19 IgG Rapid Test is to establish the diagnosis of a patient infected with SARS-CoV-2 by clinical signs and other laboratory diagnostic tests. The COVID-19 IgG Rapid Test result should not be used as the sole test to establish the diagnosis.
The result is limited to the detection of SARS-CoV-2 IgG antibodies. IgG antibodies develop later in the course of SARS-CoV-2 infection.
A negative result does not exclude SARS-CoV-2 infection and should not be used as the sole basis for medical decision making. IgG antibodies are not detectable in the first days of infection, and the sensitivity of the COVID-19 IgG Rapid Test is not yet indicative of early infection.
False positive results may be obtained when detecting IgG antibodies due to cross-reactivity with previously present antibodies or other problems.
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