Description
Product Description
The AllTest COVID-19 Antigen Rapid Test (Oral Fluid) is a single-use test kit intended to detect the novel coronavirus SARSCoV-2 that causes COVID-19 in human oral fluid. This test is intended for home use with self-collected oral fluid samples from symptomatic individuals who are suspected of being infected with COVID-19 within the first 7 days of symptom onset.
The COVID-19 Antigen Rapid Test (Oral Fluid) obtain a preliminary result only, the final confirmation should be based on clinical diagnostic results.
The COVID-19 Antigen Rapid Test (Oral Fluid) is a qualitative membrane-based immunoassay for the detection of SARSCoV-2 Antigens in human oral fluid specimen
The test device contains anti-SARS-CoV-2 antibodies.
Usage directions
Pre-testing & Materials
Before collecting oral fluid, nothing is to be placed in the mouth including food, drink, gum, or tobacco products for at least 10 minutes prior to collection. Wash or sanitise your hands. Make sure they are dry before starting.
Preparing for the test
Check the expiration date on the box. Do not use if the kit has expired.
Ensure the kit is at room temperature for at least 30 minutes prior to use. Open the box carefully as it will be used in a later step. Do not open individual components until instructed. Note: A time device (clock, timer, etc) is required, but not provided.
Sample collection
Deeply cough 3 – 5 times Note: Wear a face mask or cover your mouth and nose with a tissue when you are coughing and keep distance with other people.
Add entire disposable buffer provided, squeeze 10 to 15 times
Wait for results, Read the result at 15 minutes. Do not read the result earlier than 15 minutes or after 20 minutes. Do not touch the Test Device during this period. After the test is complete, place all the components into the plastic Bio-Safety bag. Note: A control (C) line may appear in the result window within a few minutes, but a test (T) line may take as long as 15 minutes to appear. Note: After 20 minutes the result might become inaccurate.
Interpreting Results
Invalid test result – Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test or contact our COVID-19 test centre.
Positive Result – One coloured line should be in the control region (C) and another coloured line should be in the Test region (T). *Note: The intensity of the colour in the test line region (T) will vary based on the amount of SARS-(CoV-2 antigen present in the sample. So any shade of colour in the test region (T) should be considered positive. A positive result means it is very likely you have COVID-19, but the positive samples should be confirmed to reflect this. Immediately go into self-isolation in accordance with the local guidelines and immediately contact your general practitioner/doctor or the local health department in accordance with the instructions of your local authorities. Your test result will be check by a PCR confirmation test and you will be explained the next steps.
Negative result – No apparent coloured line appears in the test line region (T) You are unlikely to have COVID-19. However, it is possible for this test to give a negative result that is incorrect (a false negative) in some people with COVID-19. This means you could possibly still have COVID-19 even though the test is negative. If you experience symptoms such as headaches, migraines, fever, loss of sense of smell or taste, contact the nearest medical facility according to the rules of our local authority. In addition, you can repeat the test with a new test kit. In case of suspicion repeat the test after 1-2 days, as the corona virus cannot be precisely detected in all phases of an infection. Even with a negative test result, distance yourself and hygiene rules must be observed, migration/traveling, attending events, etc, you should follow your local COVID guidelines/requirements.
Warnings
Always read the label. Use as directed, incorrect use could be harmful. If symptoms persist please consult your healthcare professional. Keep out of reach of children.
1. Failure to follow the testing steps may give inaccurate results. The COVID-19 Antigen Rapid Test (Oral Fluid) is for self-testing in vitro diagnostic use only. The results obtained with the test should be considered with other clinical findings from other laboratory tests and evaluations. If the test result is negative or non-reactive and clinical symptoms persist, it is because the very early infection virus may not be detected, It is recommended to test again with a new test 1-2 days later or go to the hospital to rule out infection. Positive results of COVID-19 may be due to infection with non-SARS-CoV-2 coronavirus strains or other interference factors. The COVID-19 Antigen Rapid Test (Oral Fluid) is less reliable in the later phase of infection, it is recommended to use the test within the first 7 days of symptom onset. Negative results may not mean that a person is not infectious and if symptoms are present you must seek immediate further testing Via the PCR Method. A negative result does not rule out infection with another type of respiratory virus. The test is for one time use only, do not reuse the test. Test for children and young people should be supervised with an adult.
