Package specification

Test principle

The immune complex will be captured with SARS-CoV-2 monoclonal antibody fixed on the membrane. If the test line shows colour, means positive; if the test line does not show any colour, means negative. The test card also contains a quality control line, whether the detection line is displayed or not, there will be coloured. If contains SARS-CoV-2antigen, the test line will be displayed a coloured line. Presence of this colored line indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred. If the control line does not appear, indicating the test result ismeaningless, this sample must be re-tested.

Storage

Sealed: The kit must be stored at 4-30℃, valid for 24 months. Keep dry. Opened: The test cassette must be used within 1 hour once its foil pouch is opened.

2. Place the extraction tube on the tube holder of the box. The extract reagent R1 bottle is pressed vertically downward to allow the solution to drip freely into the extractor tube without touching the edge of the tube. Add 8

drops of Extract Reagent R1 to the extraction tube.

DE IFU - Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Immunochromatography)-Self-testing