Rapid self-test for the qualitative detection of SARS-CoV-2 antigens present in human oral fluid specimens
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has been recognized as the virus responsible for the COVID-19 pandemic.
As with other respiratory diseases, SARS-CoV-2 can cause an asymptomatic infection, causing mild symptoms such as cold, sore throat, cough and fever, loss of taste and/or sense of smell, or more severe symptoms such as pneumonia and respiratory distress with a fatal outcome. The incubation period of SARS-CoV-2 varies from 1 to 14 days, with an average of 5 to 6 days.
WHO IS THIS TEST FOR?
COVID-19 SALIVA SELF-TEST is dedicated for anyone who wants to verify a possible SARS-CoV-2 ongoing infection.
Antigenic tests for COVID-19 allow to carry out a qualitative detection of SARS-CoV-2 in the salivary sample and are configured as rapid diagnostic devices to be carried out for home use. It is recommended to use COVID-19 SALIVA SELF-TEST during the time frame relating to possible exposure to the virus.
COVID-19 SALIVA SELF-TEST is an immunochromatographic assay for the qualitative detection of Nucleocapsid antigens in oral fluid specimens.
1 test cassette
1 extraction buffer
1 collection kit (plastic tube, dropper tip and funnel)
1 Biohazard specimen bag
instructions for use
Insert the funnel into the plastic tube and place the collection kit in the hole on the package. Pour the oral fluid inside the funnel;
Deposit the extraction buffer into the tube containing the fluid;
Add the dropper to the vial and press the sides of the tube in order to mix the solution;
Add 2 drops of the extracted sample and wait 15 minutes before reading the result.
SARS-CoV-2 antigens levels are not present in the sample or they are present in very low concentrations, which are not detectable by the device.
SARS-CoV-2 antigens have been detected by the diagnostic system. It is suggested to contact a specialist or the local health department for further information.
1. BACKINGER, C.L. and KINGSLEY, P.A., Recommendations for Developing User Instruction Manuals for Medical Devices Used in 9 /
57 Home Health Care, Rockville, MD, U.S. Food and Drug Administration, Center for Devices and Radiological Health, HHS Pub. FDA 93-4258.
2. WHO, Advice on the use of point-of-care immunodiagnostic tests for COVID-19 (https://www.who.int/newsroom/commentaries/detail/advice-on-the-use-of-point-of-careimmunodiagnostic-tests-for-covid-19)
3. European Centre for Disease Prevention and Control. Diagnostic testing and screening for SARS-CoV-2. 2020. https://www.ecdc.europa.eu/en/covid-19/latest-evidence/diagnostictesting. Accessed January 2022.
The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" section of the instructions for use.
The color intensity of the control and test bands may vary depending on the concentration of antigens present in the sample. Therefore, any color hue in the test region (T) should be considered as positive.
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