PRECAUTION
This kit is for in vitro diagnostic use
All specimens should be treated as capable of transmitting diseases. Use appropriate precautions in the collection, handling,storage and disposal of patient samples and used kit contents. And follow biosafety level 2 or higher guidelines.
Wear appropriate personal protective equipment (e.g. gowns, gloves, eye protection) when handing the contents of this
Proper specimen collection storage and transport are critical to the performance of this
Discard after first use. The test cannot be used more than
Do not touch the reaction area of test
Do not use test kit beyond the expiration
Do not use the kit if the pouch is punctured or not well
Testing should be applied by professionally trained staff working in certified laboratories or clinics at which the sample(s) is taken by qualified medical
The test result should be interpreted by the physician along with clinical findings and other laboratory test
DISPOSAL OF THE DIAGNOSTIC: All specimens and the used-kit has the infectious risk. The process of disposing the diagnostic must follow the local infectious disposal law or laboratory
PRINCIPLE
COVID-19 Antibody Test (Lateral Flow Method) is based on the principle of capture immunoassay for determination of SARS-CoV-2 IgG/IgM antibodies in human whole blood, serum and plasma. When the specimen is added into the test device, the specimen is absorbed into the device by capillary action, mixes with the SARS-CoV-2 antigen-dye conjugate and flows across the pre-coated membrane.
When the SARS-CoV-2 antibodies level in the specimen is at or above the target cutoff (the detection limit of the test), the antibodies bound to the antigen-dye conjugate are captured by anti-human IgG antibody and anti-human μ chain antibody immobilized in the Test Region (T) of the device, and this produces a colored test band that indicates a positive result. When the SARS-CoV-2 antibody level in the specimen is zero or below the target cutoff, there is not a visible colored band in the Test Region (T) of the device. This indicates a negative result.
To serve as a procedure control, a colored line will appear at the Control Region (C), if the test has been performed properly.
