Test Kit for Coronavirus: IgM/IgG Anitbody Fast Decttion Kit Colloidal Gold

2020-04-01

SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) is a newly launched fast diagnostic product for fast qualitative test of SARS-CoV-2 IgM/IgG antibody in human serum/plasma/whole blood.

This product has already completed the European In Vitro Diagnostic Medical Devices Directive (IVDD) compliance statement and registration in the European Union, and has been qualified for EU market access.

How it works?

SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) adopts colloidal gold-immunochromatography assay (GICA). The test card contains 1) colloidal gold-labeled antigen and quality control antibody complex; 2) nitrocellulose membranes immobilized with two test lines (M line and G line) and one quality control line (C line).

When an appropriate amount of sample is added to the sample well of the test card, the sample will move forward along the test card under capillary action. If the sample contains an IgM/IgG antibody of SARS-CoV-2, the antibody will bind to the colloidal gold-labeled SARS-CoV-2 antigen, and the immune complex will be captured by the monoclonal anti-human IgM antibody or monoclonal IgG antibody immobilized on the nitrocellulose membrane to form a purple-red M line or G line, showing that the sample is positive for IgM or IgG antibody.

Test Procedure

How to read the rest result?

Negative: If only the quality control line C appears, and the test lines M and G are not colored, it indicates that no antibody is detected, and the result is negative.

Positive:

IgM Positive: If both the quality control line C and the test line M appear colored, it indicates that the IgM antibody is detected, and the result is positive for IgM antibody.

IgG Positive: If both the quality control line C and the test line G appear colored, it indicates that the IgG antibody is detected, and the result is positive for IgG antibody.

IgM and IgG Positive: If the quality control line C and the test lines M and G all appear colored, it indicates that the IgM and IgG antibodies are detected, and the result is positive for both IgM and IgG antibodies.

INVALID: If the quality control line C is not observed, the test result is invalid regardless of whether there is a colored test line, and it should be tested again.

The sensitivity, specificity and accuracy of SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) have passed the performance verification test of Institute of Biomaterials and Medical Devices.

Test Result:

Through the test results of using SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) to test on SARS-CoV-2 virus nucleic acid positive blood samples and negative blood samples, and blank diluent, it can be seen: The sensitivity of the reagent began to fail to detect IgG-positive strip after the S13HC antibody protein was diluted to 80 times (concentration: 71.4ng/mL); The detection accuracy of the reagent for positive samples was 100%, and the accuracy for negative samples was 95.8%; The test results of reagent on diluent were all negative, and the coincidence rate was 100%.

Conclusion:

The sensitivity, specificity and accuracy of SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) are very high. SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) is applicable to the detection and scientific research of SARS-CoV-2 virus antibodies in blood.

To see more information and knowledge of Colloidal Gold method, please find it at wikipedia.

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