SARS-CoV-2 (COVID-19) IgM/IgG

Antibody Fast Detection Kit (Colloidal Gold)

A newly launched fast diagnostic product developed by Jiangsu Superbio Biomedical (Nanjing) Co., Ltd. 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.

Test Principle

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.

Specification

1 test/pack; 20 tests/box.

Material Supplied

1. Disposable test card
2. Disposable plastic dropper
3. Sample Diluent
4. Peripheral blood collector
5. Cotton swabs
6. Desiccant
7. Instruction manual

STORAGE CONDITIONS AND VALIDITY

1. The original packaging should be stored in a dry place at 4-30°C and protected from light. The period of validity is 12 months.

2. After opening the inner package, the test card will become invalid due to moisture absorption, please use it within 1 hour.

APPLICABLE SPECIMEN

This product is applicable to human serum, plasma or whole blood samples, including peripheral blood, plasma prepared from clinically used anticoagulants (EDTA, heparin, sodium citrate), etc.

Test Procedure

Interpretation of Results

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.

 IgG and IgM 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.

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PERFORMANCE CHARACTERISTICS

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 Nanjing Institute of Biomaterials and Medical Devices (Southeast University). Test results and conclusion are as follows:

Test Results:

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.

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