COVID-19 IgM/IgG Antibodies Rapid Test Kit (Colloidal Gold)

IgG Antibody Rapid Test Specification

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,

 IgM And IgG Rapid Test Features

• 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.

 

Rapid Antibody Test IgM IgG Test Principle

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.