The COVID-19 IgM/IgG Antibodies Rapid Test assay is a lateral flow immunoassay intended for qualitative detection and differentiation of IgM and IgG antibodies to SARS-Cov-2 in human serum, plasma (potassium EDTA), and venous whole blood.
COVID-19 IgM/IgG Antibodies Rapid Test
UDXBIO
COVID-19 IgM/IgG Antibodies Rapid Test
Availability: | |
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Product Description
Parameter of COVID-19 IgM/IgG Antibodies Rapid Test Kit (Colloidal Gold) | ||
Material | pp | |
Whole Blood | Sensitivity | 97.5% |
Specificity | 98.5% | |
Plasma | Sensitivity | 98.4% |
Specificity | 99.1% | |
Serum | Sensitivity | 97.9% |
Specificity | 99.2% | |
Test type | IgM/IgG Antibodies | |
Test time | 5-10 minutes | |
Test method | Colloidal Gold | |
Specimen | Serum, plasma, or venous whole blood | |
Keep temperature | 2-30℃ | |
Certification | CE, ISO 13485 2016 | |
Shelf-life | 18 months | |
Package | Carton Box, 1 set/kit, 5 sets/kit, 20sets/kit,25 sets/kit, |
Fast. You can read the result within 5-10 minutes, faster than PCR test.
Simple. Easy to use and easy to get the specimen, no equipment required, no PCR lab required.
Convenient. Can be used in many places like station, airport, hospital, school and very convenient.
This test is based on colloidal gold immunoassay.
During the test, specimens and detection buffer are applied to the test cartridges. If there are COVID-19 IgG or IgM antibodies
in the specimens, they combine with colloidal gold-labeled COVID-19 recombinant antigen forming IgM-virus antigen-colloidal
gold complex (complex M) or IgG-virus antigen-colloidal gold complex (complex G).
During lateral flow, the complex M and complex G move along the nitrocellulose membrane toward the end of the absorbent paper.
When passing the line M (coated with anti-human IgM antibodies), the complex M is captured by anti-human IgM antibody resulting
in coloring on line M; when passing the line G (coated with anti-human IgG antibodies), the complex G is captured by anti-human
IgG antibody resulting in coloring on line G; when passing the line C, colloidal gold-labeled DNP is captured by quality-control antibody resulting in coloring on line C.
Rapid Antigen Test IgG IgM Components
1. 1 test/kit
Test cartridge 1/kit
Detection buffer 1 bottle/kit (enough for 1test)
Pipette 1/kit
Instructions for use 1 copy/kit
2. 5 tests/kit
Test cartridge 5/kit
Detection buffer 1 bottle/kit (enough for 5 tests)
Pipette5/kit
Instructions for use 1 copy/kit
3. 20 tests/kit
Test cartridge 20/kit
Detection buffer 1 bottle/kit (enough for 20 tests)
Pipette 20/kit
Instructions for use 1 copy/kit
4. 25 tests/kit
Test cartridge 25/kit
Detection buffer 1 bottle/kit (enough for 25 tests)
Pipette 25/kit
Instructions for use 1 copy/kit
5. 50 tests/kit
Test cartridge 50/kit
Detection buffer 2 bottles/kit (enough for 50 tests)
Pipette 50/kit
Instructions for use 1 copy/kit
Materials required but not provided
1. Specimen collection tubes
2. Timer
Test Method
The test should be performed at room temperature(15-30℃).
Step 1: Preparation
Take out the test kit, detection buffer, and sample to be tested and balance them to room temperature.
Tear and open the aluminum foil pouch, take the test cartridge out, and put it on the table horizontally.
Step 2: Sampling and Loading
Use the pipette (provided within the kit) to take specimen from the original specimen container and add 1 drop (10~15uL) specimen (plasma,
serum or venous whole blood) into the “S” well of the test cartridge. Then add 2 drops of detection buffer (~100uL) using the drip bottle
containing detection buffer into the “D” well of the test cartridge.
Step 3: Testing
Wait 10 min to allow the reaction to complete and read the result visually afterward. Results should be read between 10 and 20 min.
Result Interpretation
1. Negative result: there is coloration on line C only showing as following picture, suggesting that there is no SARS-Cov-2 IgG or IgM antibody in the sample.
2. Positive result: the results show as following pictures. There is coloration on line C, line G and/or line M, showing as follow
pictures, suggesting that there is SARS-Cov-2 IgG and/or IgM antibody in the sample.
3. Invalid result: there is no coloration on line C showing as following pictures, suggesting that invalid test or error operation.
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