Product
Test Reagent
Package Inset of SARS-Cov-2 Antibody Test Strip
On December 31, 2019, several cases of pneumonia in Wuhan City, Hubei Province of China were reported to the World Health Organization (WHO).Product Name
SARS-CoV-2 Antibody Test Strip (Colloidal Gold Method)
Package Size
1 strip/foil bag, 1 strip/box, 2 strips/box, 5 strips/box, 20 strips/box, 25 strips/box, 30 strips/box, 40 strips/box, 50 strips/box, 100 strips/box
Intended Use
The SARS-CoV-2 Antibody Test Strip is for the qualitative detection of SARS-CoV-2 antibody in human serum, plasma or whole blood sample. It is intended for use outside the body only（in vitro diagnostic use）for professional use.
Summary
On December 31, 2019, several cases of pneumonia in Wuhan City, Hubei Province of China were reported to the World Health Organization (WHO). The novel virus, now known as SARS-CoV-2
(previously known as 2019-nCoV), has spread in many countries and regions around the world. The WHO has named the disease caused by SARS-CoV-2 as coronavirus disease 2019 (abbreviated“COVID-19”).
Test Principle
SARS-CoV-2 Antibody Test Strip is based on colloidal gold immunochromatography assay to test SARS-CoV-2 antibody. Colloidal gold marked goat anti-chicken IgY polyclonal antibody and recombinant SARS-CoV-2 antigen are coated in reagent conjugate pad. Mouse anti-human IgG monoclonal antibody and mouse anti-human IgM monoclonal antibody are coated in detection area of nitrocellulose membrane. Chicken IgY is coated in control area. During test, specific SARS-CoV-2 antibody in blood sample conjugates with colloidal gold marked recombinant SARS-CoV-2 antigen to form immune complex. Owing to capillary action, immune complex flow across the membrane. If blood sample contain specific SARS-CoV-2 antibody, it will be captured by the test area coated mouse anti-human monoclonal antibody and form a visible line in test area (test line). Excess colloidal gold marked goat anti-chicken
IgY polyclonal antibody keeps moving, specific binding with control area coated Chicken IgY and from a visible line in control area (control line). If blood sample doesn’t contain SARS-CoV-2
antibody, only control line will be appeared
