FASPIT™ SARS-CoV-2 Antigen Saliva Test Kit is an immunochromatographic assay that uses the double-antibody sandwich method to detect the SARS -COV-2 nucleocapsid protein from saliva specimen from patients who are suspected of SARS-CoV-2 infection. For in vitro diagnostic use only.
Identifier (Product Code) : C2112
Lot Number : 20220309
MDA Conditional Approval Number : (15) MDA.600-1/6/35
Attention 1: Do not eat, drink, smoke or use oral hygiene products for at least 10 minutes before the collection process. 1.Rinse individual's mouth with clear water and discard before test. 2.Wait for 5 mins to naturally produce saliva and keep saliva in oral cavity. 3.Unpack the aluminum foil bag, take out the saliva stick and hold the handle and immerse stick in saliva below the tongue, hold for several seconds until burgundy color shows in test window.
Attention 2: Please do not suck and swallow while
COVID-19 Antigen Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens present in human oral fluid. When the control line(C) appears, it means the test unit is performing well.
You can read your results after 15 minutes as long as a coloured line has appeared next to the Control region(C), do not read result after 20 minutes.
Test can be done at any time of the day. However It is recommended to collect the first oral fluid in the morning.
The results will only give accurate results as far as the fresh human oral fluid is used and followed the instructions carefully. Nevertheless, the result can be incorrect. Non-SARS-CoV-2 coronavirus strains or other interference factors may cause a preliminary Positive Result.
The color and intensity of the lines have no importance for result interpretation. The test should be considered as Positive whatever the color intensity of the test line (T).
A positive result means the presence of SARS-CoV-2 antigens. A positive results means it is very likely you have COVID-19 and the result should be confirmed. 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 checked by a PCR confirmation test and you will be explained the next steps.
Alternatively, report to MOH via MySejahtera App. The steps to do this: Go to Helpdesk, press ‘Start’ and click ‘Section F’ which indicates I am Covid-19 positive and would like to report my result.
A negative result means that you are negative or that the viral load is too low to be recognized by the test. 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 and taste, contact the nearest medical facility using the rules of your 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 coronavirus cannot be precisely detected in all phases of an infection. Distance and hygiene rules must still be observed. Even with a negative test result, distance and hygiene rules must be observed, mitigation/traveling, attending events and etc should follow your local COVID guidelines/requirements.