ISO 13485 Certificate

【Test principle】 This kit is tested by immune chromatography. The sample will be under the capillary action to move forward along the test strip. If the sample contains SARS-CoV-2 antigen, the antigen nucleocapsid protein will be combined with a monoclonal antibody-coated particles. 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 is meaningless, 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. 【Test procedure】 1. Wash and dry your hand. Open the package and take out the test cassette. 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. 3. Put the swab specimen into the extraction tube, rotate the swab for about 15 seconds, and press the swab head against the tube wall to release the antigen in the swab. Squeeze the swab over the head to remove the swab so as to remove as much liquid as possible from the swab. Dispose of swabs into disposal bag. 4. Install the dripper on the extraction tube, put 2 drops into the sample hole of the test cassette, and start the timer. 5. Read the results in 20-30 minutes. Reading results after 30 minutes may be invalid. DE IFU - Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Immunochromatography)-Self-testing

Certificate

CE Covid-19 Antigen test kit

African clinical research organisation Confirmation Letter