COVID-19 Total Antibodies Rapid Test

Antibodies Rapid Blood Test Description

The COVID-19 Total Antibodies Rapid Test is a lateral flow immunoassay intended for the qualitative detection of total 

antibodies to SARS-CoV-2 in human serum, plasma or whole blood. The COVID-19 Total Antibodies Rapid test is intended

for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

The COVID-19 Total Antibodies Rapid test should not be used to diagnose or exclude acute SARS-CoV-2 infection.

For in vitro diagnostic use only.

For professional use only.

Antibodies Rapid Test Specification

Parameter of COVID-19 Total Antibodies Rapid Test Kit (Colloidal Gold)
Material		pp
Whole Blood	Sensitivity	97.5%
	Specificity	97.8%
Plasma	Sensitivity	97.1%
	Specificity	98.3%
Serum	Sensitivity	97.7%
	Specificity	98.3%
Test type		Total Antibodies
Test time		10-20 minutes
Test method		Colloidal Gold
Specimen		Serum, plasma or whole blood
Keep temperature		2-30℃
Certification		CE, ISO 13485 2016
Shelf-life		18 months
Package		Carton Box, 1 set/kit, 20 sets/kit, 25 sets/kit, 50 sets/kit

 

Antibody Quick 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. 

 

Quick Antibody Test Test Principle

This reagent is based on a lateral flow immunoassay.

During the test, specimens are applied to the test cartridges. If SARS-CoV-2 antibody is present in

the specimen, they combined with colloidal gold-labeled SARS-CoV-2 recombinant antigen forming

antibody-virus antigen-colloidal gold complex (complex T).

During lateral flow, the complex T move along nitrocellulose membrane toward one end of the

absorbent paper.

When passing through the line T (coated with same SARS-CoV-2 recombinant antigen), the complex T

is captured by recombinant antigen resulting in coloring on line T; when passing through the line C, 

colloidal gold-labeled DNP is captured by quality-control antibody resulting in coloring on line C.

Rapid Antibody Test 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

 

Material Required (But Not Provided)

1. Specimen collection containers 

2. Timer

 

Test Procedure

The test should be operated at room temperature(15~30℃).

Step 1: Preparation

Take out the test kit and specimen to be tested, then balance them to room temperature(15~30℃).

Tear and open the aluminum foil bag, take the test cartridge out and put them on the table horizontally.

Step 2: Sampling and Loading

Drip 1 drop (~30uL) specimen(serum, plasma or whole blood) with the pipette (provided within the kit) into the

“S” well of the test cartridge. Then add 1 drop of detection buffer (~40uL) into the “D” well of the test cartridge. 

Insure that there is no bubble emerging during the process.   

Step 3: Testing

Wait 10 min to allow the reaction completing and read the result visually afterward. Results should be read between

10 and 20 min.

 

X. Result Interpretation

1. Negative result: there is coloration on line C only, suggesting that there is no SARS-CoV-2 Total antibodies in the

specimens.

2. Positive result: the results show as following pictures. There is coloration on line C and line T, suggesting that there

is SARS-CoV-2 Total antibodies in the specimens.

3. Invalid result: there is no coloration on line C, suggesting that invalid test or error operation.

 

Test result