This product is used for in vitro diagnostic test for the qualitative detection of the antigen of SARS-CoV-2 (novel coronavirus) in human nasopharyngeal and/or oropharyngeal swabs. This instruction for use (IFU) must be read and followed carefully prior to use. The reliability of assay results cannot be guaranteed in case of any discrepancies from the instructions for use.
This kit by immune chromatography test, the sample will be under the capillary action to move forward along the test cassette. If the sample contains SARS-CoV-2 antigens, these antigens will be with colloidal gold labeled coronavirus monoclonal antibody. This immune complex will be membrane fixed by coronavirus monoclonal antibody capture, form the purple line which reveals a positive result. If the line does not show any color, the negative result will be displayed. The test cassette also contains a quality control line C, which shall appear in purple regardless of whether there is a detection line.
Test cassette contains SARS-CoV-2 antibody-coated in the test region and Goat anti-Chicken IgY polyclonal antibody-coated in the control region on the membrane. The test cassette consists of the SARS-CoV-2 antibody, Chicken IgY, and Colloidal gold conjugate coated in the conjugate pad. The specimen extraction solution is a phosphate solution.
Antigen Diagnostic Kit 15 min. it gives quick results in it.
%98,6 Precision Ratio
The test result will be 98,6% accurate.
Approved by the Ministry of Health
T.R. It is a sales kit approved by the Ministry of Health.
WARNINGS AND PRECAUTIONS
The DEJAVU COVID-19 Antigen Test detects the presence of viral proteins expressed by the Nasopharyngeal and Oropharyngeal Swab and SARSCoV-2 sampling.
This product is used for in vitro qualitative detection of antigens. SARS-CoV-2 (novel coronavirus) in human nasopharyngeal and / or oropharyngeal swabs. The instruction for use (IFU) is provided in the test kit and should be carefully read and followed before use.