Coronavirus (COVID-19)

[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

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A statistical comparison was made between the results yielding a sensitivityof 87.01%, a specificity of 98.89% and an accuracy of 93.41%

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[Test principle]

Immunochromatogra is used in this kit. The test card contains:

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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 quality control C

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[Operation steps]

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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.

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[Interpretation of test results]

Positive: Control at least one test ar on the membrane.The appearance of IgG test cates the presence of Novelcoronavirus specific IgG antibodies. The appearance of IgM test ndicates the presence of Novel coronavirus specific IgM antibodies. And ifboth IgG and IgM ar, it indicates that the presence of both Novelcoronavirus specific IgG and IgM antibodies.Negative: One colored ars in the control region(C).No apparentcolored ars in the test on.Invalid: Control s to appear. Insufficient specimen volume orincorrect procedural techniques are the most likely reasons for control ailure. Review the procedure and repeat the test with a new test cassette. Ifthe problem persists, discontinue using the test kit immediately and br>your local distributor.

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Certification: CE and ISO13485

Easy to be used, top high qualityÂ

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OEM packaging in our company is available.