SARS-CoV-2 Antibody Test Strip for 5 personal package CE Approved(Colloidal Gold Method)
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 onlyin
vitro diagnostic usefor professional use.
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
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.
The test can be performed with serum, or plasma/whole bloodsample which collected in EDTA or heparin blood collection tube.Serum or plasma sample can be stored at 2℃~8℃ for up to 3 days or -20℃ for 9 days. Avoid repeated freezing and thawing. It is recom mended to test whole blood sample within 3 days after collected. Wholeblood sample should be stored at 2℃~8℃. Do not freeze. Do not use hemolytic sample or contaminated sample to perform test.
Read the package insert carefully before test.
a.Allow the test strip and samples to equilibrate to room temperature before testing.
b.Check expiry date of strip. Do not use test strip which beyond expiry date printed on the label.
c.Take out a strip from foil bag and place it on a dry level surface.
Insert dropper slantwise into blood collection tube (within 0.5cm),gently touch sample to absorb sample. Dropper will absorb sampleautomatically until it reaches to scale mark on dropper (10μL). Do not press top of dropper when absorb samples. Then use dropper gently touch sampling area on strip, gently squeeze the top of dropper to adding all the sample.
b.Gently squeeze the dropping bottle of sample diluent, add 2~3
drops diluent vertically into sampling area (see picture 1).