COVID-19 IgG/IgM Rapid Test Device,SHBC_specification/price/image

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1. Product Instruction

The New Coronavirus(COVID-19)lgG/lgM Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of lgG & ligM antibody of WUHAN New Coronavirus in human whole blood in human whole blood, serum,or plasma as an aid in the diagnosis of COVID-19 infections.

2.Princple

This kit uses immunochromatography.The test card contains:1) colloidal gold-labeled recombinant new coronavirus antigen and quality control antibody gold markers;2) two detection lines(G and M lines) and one quality Control line(C line) of nitrocellulose membrane.
The M line is immobilized with a monoclonal anti-human lgM antibody for detecting a new coronavirus lgM antibody;the G line is immobilized with a reagent for detecting a new coronavirus lgG antibody; and the C line is immobilized with a quality control antibody.
When an appropriate amount of the test sample is added to the sample hole of the test card, the sample will move forward along the test card under the action of the capillary.If the sample contains an IgM antibody, the antibody will bind to the collidal gold-labeled new coronavirus antigen. The immune complex will be captured by the anti-human lgM antibody immobilized on the membrane to form a purple-red M line, showing that the new coronavirus lgM antibody is positive.
If the sample contains an IgG antibody, the antibody will bind to the colloidal gold-labeled new coronavirus antigen,and the immune complex will be captured by the reagent immobilized on the membrane to form a purple-red G line, indicating that the new coronavirus lgG antibody is positive.
If the test lines G and M are not colored,a negative result is displayed.The test card also contains a quality control line C.The fuchsia quality control line C should appear regardless of whether a test line appears.The quality contro line is a color band of the quality control antibody immune complex. If the quality control line C does not appear, the test result is invalid, and the sample needs to be tested again with another test card.

3. Directions For Use

Allow the test device, specimen, buffer, and/or controls to reach room temperature (15-30°C)prior to testing.
1). Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
2). Place the test device on a clean and level surface.
● For Serum or Plasma Specimens:
Using the provided 5uL disposable pipette,and transfer 1 drop of serum/plasma to the specimen wellof the test device,then add 2 drops of buffer and start the timer.
● For Whole Blood(Venipuncture/Fingerstick)Specimens:
Using the provided 5uL disposable pipette,and transfer 2 drop of whole blood
(approximately 20uL) to the specimen well of the test device,then add 2 drops of buffer and start the timer.
Note: Specimens can also be applied using a micropipette.
3). Wait for the colored line(s) to appear.Read results at 10 minutes.Do not interpret the result after 15 minutes.

4. Specifications:

25 Tests/kit

1 Test/kit

5.STORAGE ANDSTABLITY

●The original packaging should be stored at 4~30℃, to avoid light, keep dry.
●The test device is stable through the expiration date printed on the sealed pouch.The test device must remain in the sealed pouch until use.DO NOT FREEZE.
● Do not use beyond the expiration date, especially at temperatures above 30℃ or under high humidity conditions,should be used immediately once itis opened.