1. Description of the product
COVID-19/COVID-19 IgG/IgM Rapid Test Kit/COVID-19 Rapid Test Kit/Rapid Test Kit

Product name: COVID-19 IgG/IgM Rapid Test Kit
Intended use:COVID-19 IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma) is a solid
phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG
and IgM antibodies to 2019 Novel Coronavirusi in human whole blood, serum or plasma.
Principle: The COVID-19 IgG/IgM Rapid Test kit (Whole Blood/Serum/Plasma) is a lateral
flow immunochromatographic assay. The test uses anti-human IgM antibody (test line IgM),
anti-human IgG (test line IgG) and goat anti-mouse IgG (control line C) immobilised on a
nitrocellulose strip. The burgundy colored conjugate pad contains colloidal gold conjugated to
recombinant COVID-19 antigens conjugated with colloid gold (COVID-19 conjugates) and
mouse IgG-gold conjugates. When a specimen followed by assay buffer is added to the
sample well, IgM &/or IgG antibodies if present, will bind to COVID-19 conjugates making
antigen antibodies complex. This complex migrates through nitrocellulose membrane by
capillary action. When the complex meets the line of the corresponding immobilized antibody
(anti-human IgM &/or anit-human IgG) the complex is trapped forming a burgundy colored
band which confirm a reactive test result. Absence of a colored band in the test region
indicates a non-reactive test result.