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.
COVID-19 Total Antibodies Rapid Test
UDXBIO
COVID-19 Total Antibodies Rapid Test
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Product 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.
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 |
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 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.
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
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