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                    SARS-CoV-2 Antigen Rapid Test (Fluorescence)

                    預期用途

                    PACKING SPECIFICATION

                    20 Tests/ Kit

                     

                    INTENDED USE

                    This kit is used for in vitro qualitative detection of SARS-CoV-2 antigen in human nasopharyngeal swab and oropharyngeal swab samples.


                    PRINCIPLE OF THE PROCEDURE

                    This kit utilized the principle of double antibody sandwich reaction and fluorescent immunochromatographic analysis technology to qualitatively detect SARS-CoV-2 antigen in human nasopharyngeal swabs and oropharyngeal swabs samples.

                    During the test, if the test sample contains SARS-CoV-2 antigen, the SARS-CoV-2 antibody labeled with fluorescent particles (Eu-SARS-CoV-2-Ab) binds to the SARS-CoV-2 antigen in the sample to form “(Eu-SARS-CoV-2-Ab)-(SARS-CoV-2) ” reaction complex, the reaction complex moves forward along the nitrocellulose membrane under the action of chromatography, and binds to the SARS-CoV-2 antibody pre-coated in the detection zone (T), to form "(Eu-SARS-CoV-2-Ab)-(SARS-CoV-2-Ag)- (SARS-CoV-2-Ab)" double antibody sandwich, and finally form a reaction line with a fluorescent signal in the T region; Instead, the detection value lower than cut-off value in the T region would regard as negative samples. Regardless of whether the sample to be tested contains the SARS-CoV-2 antigen, the control area (C) will always form a fluorescence reaction line. The test card is detected by the matching immunofluorescence analyzer, and the result will be interpreted.

                    REAGENTS AND MATERIALS SUPPLIED

                    1. Main components:

                    Specification

                    Components

                    20 tests/kit

                    Test card with   desiccant in a sealed foil pouch

                    20

                    Sample extraction solution

                    1

                    Extraction   Tube holder

                    1

                    Extraction   Tube

                    20

                    Dripper

                    20

                    Swab

                    20

                    ID chip

                    1

                    Instruction for use

                    1


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