rapid test covid-19,CE FDA Cerficates Coronovirus-19 IgG/IgM
Antibody test kit
[Product name]
Novel coronavirus COVID-19 IgM/IgG detection reagent test card, CE
mark
[Intended use]
The novel coronavirus IgG is used for the qualitative detection of
human coronavirus in human serum, plasma, whole blood or fingertip
blood. And IgM antibodies
A statistical comparison was made between the results yielding a
sensitivity
of 87.01%, a specificity of 98.89% and an accuracy of 93.41%
[Test principle]
Immunochromatography is used in this kit. The test card contains:
1) binding pad novel coronavirus antigen and quality control
antibody gold marker labeled by colloidal gold.
2) NC membrane: IgM single test card: coated with mouse anti human
IgM antibody detection line and quality control C line; IgG
[Operation steps]
1. If the reagent is stored in the refrigerator at 2-8 ℃, take out the
reagent card and balance at room temperature for more than 30min.
2. Open the aluminum foil bag of the test card. Remove the test card and place it horizontally on the desktop.
3. Use a pipette to take 10ul of sample (serum, plasma or whole blood)
and add it into the sample hole of the test card, and then set it
up
Add 80ul sample diluent.
Read the result at 4.15min. The results read after more than 15 minutes are invalid.
[Interpretation of test results]
Positive: Control line and at least one test line appear on the
membrane.
The appearance of IgG test line indicates the presence of Novel
coronavirus specific IgG antibodies. The appearance of IgM test line
indicates the presence of Novel coronavirus specific IgM
antibodies. And if
both IgG and IgM line appear, it indicates that the presence of
both Novel
coronavirus specific IgG and IgM antibodies.
Negative: One colored line appears in the control region(C).No apparent
colored line appears in the test line region.
Invalid: Control line fails to appear. Insufficient specimen volume or
incorrect procedural techniques are the most likely reasons for
control line
failure. Review the procedure and repeat the test with a new test cassette. If
the problem persists, discontinue using the test kit immediately
and contact
your local distributor.
Certification: CE and ISO13485
Easy to be used, top high quality
| Product name | Novel coronavirus COVID-19 IgM/IgG detection reagent test card, CE
mark |
| Function | Detection of human new coronavirus |
| Test principle | Immunochromatography is used in this kit |
