Through independent research and development, our company has developed a SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold) and determined a set of production processes to ensure product sensitivity and specificity. The company's entire SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold) will be produced strictly in accordance with the following production process to ensure stable product quality.


Principles of the test

The major principle of this test kit is immunochromatography and SARS-CoV-2 IgM/IgG antibodies in serum, plasma and whole blood samples can be captured by the kit. Antibodies to μ-chain and antibodies to human IgG are coated on the nitrocellulose membrane (NC membrane) and another set of antibodies of SARS-CoV-2 are placed on the surfaces of colloidal gold particles. Blood cells in serum, plasma and whole blood samples will be removed after passing the filter membrane and if SARS-CoV-2 exists in the samples, the virus will bind to the labeled antigenon the colloidal gold particles and captured by the secondary antibodies (anti μ-chain and anti human IgG) in the testing area (T). Then a red line called reaction line is formed to show the positive result. For the negative result the line will not be seen. In normal test conditions, a line in the quality control area will be seen to indicate the validity of the test.



Intended Use

The test results of this kit can be used as supplemental indexes of negative nucleic acid test results of cases with specific symptoms or nucleic test results of suspected cases. The IgG/IgM test result should not be used as the major proof of SARS-CoV-2diagnoses.


Testing Procedure

Read the handbook carefully. Put samples, testing reagents and other materials to room temperature and then perform the test.

  1. Stored samples and reagents should be put back to room temperature 15-30 and be uniformly blended before the test.

  2. Open the aluminum bag of the cartridge and put the cartridge on a horizontal desk. The cartridge should be used within 1 hour.

  3. Wipe the finger with an alcohol pad to sterilization.

  4. Remove the cap of the lancet and put it on the tip of the finger. Push the lancet toward the finger. The lancet will pinch the fingertip and blood drops will come out.

  5. Use the blood pipette to collect the blood drops and then put the blood drops into the sample port of the cartridge.

  6. Put 2 or 3 drops of Diluent Buffer into the port immediately with the dropper. Ensure no bubble formed during the operation.

  7. Read the result in 5 to 10 minutes and the results should not be valid after 15 minutes.


Analysis of the Results

Invalid: no red line in the QC area (C). Redo the test with a new cartridge and make sure enough amount of sample was added to the cartridge.Positive: one or two red lines in the test area (T) and one red line in the QC area (C).Negative: only one red line in the QC area (C).

            Negative                                          Positive



Materials

  • Test cartridge      20 pcs

  • Disposable dropper     20 pcs

  • Diluent Buffer (15mL)      20 tubes, 0.75mL each

  • Alcohol Pad        20pcs

  • Lancet            20 pcs

  • Blood Pipette     20 pcs

  • Handbook       20 pcs


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Shenzhen GeneBioHealth Co., Ltd
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