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This product is used to qualitatively detect the novel coronavirus (COVID-19) antigen in human saliva samples in vitro.
It can be used for rapid investigation of suspected novel coronavirus cases, and can also be used as a reconfirmation method for nucleic acid detection in discharged cases. A positive test result requires further confirmation, and a negative test result cannot rule out the possibility of infection. This kit is for home use by laymen in a non-laboratory setting (such as person’s home or certain non-traditional sites such as offices, sporting events, airports, schools etc.). It is recommended to conduct a comprehensive analysis of the condition based on the patient’s clinical manifestations and other laboratory tests.
After the test card returns to room temperature, open the aluminum foil bag of the test card and take out the test card.
Remove the blue cover of the test card, put the absorbent tip of the test card into the mouth (all the absorbent tip is pressed under the tongue), take out the test card after 2 minutes, and cover the blue cover of the test card.
Place the test card horizontally,read the displayed result within 15-20 minutes, and the results read after 20 minutes is invalid.
Note: When sampling, gently put the test card into your mouth so that saliva is naturally absorbed on the absorbent tip.
Do not eat, drink or smoke for at least 30 minutes before the test.
Saliva samples are suitable for testing this product, but it is recommended to collect saliva samples in the morning before gargling, eating or drinking.
Caution: The components after use should be treated in strict accordance with the medical waste, pay attention to protection.
Interpretation of Test Results
Positive result: Both the test line (T) and the control line (C) show color bandsas the picture shows below, indicating that COVID-19 antigen is positive.
Negative result: If only the quality control line C develops color and the test line (T) does not develop color, the COVID-19antigen is not detected and the result is negativeor the content is lower than the minimum detection limit of the product, as the picture shows below.
Invalid result: No color bandappears on the quality control line (C), and it is judged as an invalid resultregardless of whether the detection line (T) shows color band or not, as the picture shows below.
Note: The color depth of the reaction line is related to the content of the tested substance contained in the extracted sample. The result should be qualitatively determined according to whether the reaction line is colored or not regardless of the color intensity. This test card reagent contains a quality control process. When a red/purple line appears on the quality control line (C), it indicates that the operation is correct and effective, otherwise the test result is invalid.
MANDATORY CUSTOMER RECORD FORM
COVID TEST KIT FOR SELF TESTING (SALIVA SAMPLE) CUSTOMER RECORD
Customer details are to be provided by the instruction of the Medical Devices Authority for recording purposes only. Any incomplete or false information can be fined by the Medical Devices Authority. All Personal Data Privacy Act policies will be in place to protect your personal data.