Accessories:

Included:
COVID-19 IgM/IgG Ab Test Cassette
Instructions for use
Buffer
Pipette (Optional)

Required (Not Provided):
Clock or timer
Sample container
Glove
Sterile lancet (optional)

Principle of Test:
The COVID-19 IgM/IgG Ab Test, engineered with a principle that involves antibody-antigen reaction, nano-colloidal gold and immunochromatography technology, is designed for the qualitative detection of the IgM and IgG antibodies of SARS-CoV-2 in human serum, plasma, or whole blood. Mouse anti-human IgM antibodies, mouse anti-human IgG monoclonal antibodies, and goat anti-mouse IgG polyclonal antibodies (internal control) are respectively immobilized on a nitrocellulose membrane, which react to colloidal gold-labeled recombinant antigens of the SARS-CoV-2 and mouse IgG (internal control).
During the testing, SARS-CoV-2 IgM antibody in the sample captures the colloidal gold-labeled SARS-CoV-2 recombinant antigen to form an antigen-antibody complex, which was then bound to the mouse anti-human IgM monoclonal antibody coated in the M line during sample lateral flow. As a result, a red M line will appear. When SARS-CoV-2 IgG antibody in the sample captures the colloidal gold-labeled SARS-CoV-2 recombinant antigen to form an antigen-antibody complex, which is then bound to the mouse anti-human IgG monoclonal antibody coated in the G line during sample lateral flow. As a result, a red G line will appear. If the samples do not contain SARS-CoV-2 IgM or IgG antibodies, colloidal gold-labeled SARS-CoV-2 recombinant antigen cannot be bound to mouse anti-human IgM or IgG monoclonal antibodies in the M and G line regions. As a result, there is no red line in either M or G line positions. When the sample has been transported properly to the C line, regardless of what antibodies are present in the sample, colloidal gold labeled mouse IgG (internal control) should be bound to goat anti-mouse IgG polyclonal antibodies coated in the C line, and a red C line should appear. No supporting instrument or card reader is required for the COVID-19 IgM/IgG Ab Test.

Intended Use:
The COVID-19 IgM/IgG Ab Test is used for the qualitative detection of the IgM and IgG antibodies of SARS-CoV-2 (COVID-19) in human serum/plasma or whole blood.
Warning and Precautions:
Read instruction carefully before performing this test.
For in vitro diagnostic use only.
Do not use the test cassette beyond the expiration date.
The test cassette should remain in the sealed pouch until use. Do not use the test
cassette if the pouch is damaged or the seal is broken.
Do not reuse the cassette.
Properly treat and handle the specimens and used test cassettes as if they were.
potentially infectious. Dispose all specimens and used cassettes in a proper bio-hazard container. The handling and disposal of the hazardous materials should follow local, national, or regional regulations.
Do not mix and interchange different specimens.
Wear disposable gloves, lab coat and eye protection while handling potentially infectious.
material and performing the assay. Wash hands thoroughly afterwards.
Clean spills thoroughly using an appropriate disinfectant.
Keep out of reach of children.
Do not swallow the desiccant.
Hemolytic samples cannot be used for testing.
Do not use turbid contaminated samples for testing.
This kit may show negative results under the following conditions: when the SARS-CoV-2 antibody titer in the sample is below the minimum detection limit of the kit, or the SARS-CoV-2 antibody has not been formed by the individual being tested at the time of sample collection.
If the test result is negative, the possibility of infection (In window period or false-negative) cannot be ruled out. Comprehensive analysis should be conducted in combination with clinical indicators, and re-examination should be conducted one week later.

Instructions for Use:
Specimen Preparation:
1.The specimen is human serum/plasma and whole blood, including clinical anticoagulants (EDTA, heparin, sodium citrate) origin-prepared plasma or whole blood.
2.Perform the test immediately after specimen collection. Fingertip blood samples should be tested immediately. Serum, plasma, and anticoagulated whole blood are collected, stored at room temperature for no more than 36 hours, at 2–8°C for no more than three months. Serum/plasma can be stored at -20°C for an extended period. Deteriorated samples may affect the results.
3.Pre-warm the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed. The precipitate should be removed by centrifugation prior to the test if clearly visible particles exist in the specimen.
4.Do not perform the test if specimen is turbid or has massive lipid or hemolysis.
Test Procedure:
1.Read the instruction first prior to testing.
2.Bring the pouched test to room temperature prior to testing.
3.Do not open the pouch until ready to begin testing.
4.Remove the test cassette from the sealed pouch. Lay it on a flat, clean, and dry surface.
5.Use the 10 μl pipette provided to withdraw the specimen to the marked line. Dispense the specimen to the sample well.
6.Hold the buffer bottle vertically and add two (2) drops of buffer (approximate 70 μl) to sample well.
7.Read results in 10–15 minutes.

Interpreting the Results:
IgG & IgM Positive: Control line (C), G line, and M line appear in the test window.
IgM Positive: Two colored lines appear. One is in M area, and the other is in control area.
IgG Positive: Two colored lines appear. One is in G area, and the other is in control area.
Negative: Only one line appears in control area. No line appears in G/M area.
Invalid: No line appears in the control area. The test results are invalid regardless of the presence or absence of colored line in the test area. The cause of failure can be that the directions have not been followed correctly or the test materials may be deteriorated. It is recommended to redo the test using a new test cassette. If the problem persists, stop using this test kit and contact our local distributor.