A in-vitro diagnostic rapid self-test using nasal swab for the qualitative detection of SARS-CoV-2 antigens (Ag)
An in-vitro diagnostic rapid self-test using nasal swab for the qualitative detection of SARS-CoV-2 antigens (Ag). Suitable for people with COVID-19 symptoms to assist the early diagnosis of SARS-CoV-2 infection.Can also be used by people without COVID-19 symptoms to regularly monitor theirCOVID-status.
Contact a healthcare provider in case of a positive result. Additional testing may be required to confirm viral infection or to initiate infection tracing. Always follow local and governmental recommendations.
BEFORE PERFORMING THE TEST: Read and follow the instructions. Perform the test at room temperature.Blow nose to clear nasal cavities. Wash your hands before and after.
TAKING THESAMPLE: 1 Open the package containing the sampling swab. Do not touch the swabtip. Gently insert the tip of the swab into one nostril, 2-3 cm. Press itagainst the nasal wall and rotate for 20 seconds to collect nasal secretion.Repeat in the other nostril. 2 Remove the sample extraction tube seal andinsert the swab. Press it against the sides and rotate for 10 seconds. 3Squeeze the sides of the tube to expel sample solution from the swab. Place thetube cap firmly onto the tube. Avoid touching the top of the tube cap. Shakethe tube, or gently press the tube, to mix the sample solution. Let it rest forone minute to release viral antigens.
TESTPROCEDURE: 4 Peel to open the foil pouch and remove the test cartridge fromits package. Place it on a flat surface. Avoid touching the well and window ofthe test cartridge. 5 Turn and tap the test tube to mix the liquid again. Avoidtouching the top of the tube cap. Hold the tube upside down and squeeze toexpel 3 drops of sample solution into the loading well. Testresult is displayedafter 15-30 minutes.
RESULTS: POSITIVE:Red line at C and T, regardless of how faint. White line at T is considerednegative. NEGATIVE: Red line at C only, see Limitations. INVALID: Without lineat C, retest with another test cartridge.
AFTER TESTING: Contact a healthcare provider in case of a positive result. Additionaltesting, such as PCR test, may be required to confirm viral infection or toinitiate infection tracing. Always follow local and governmentalrecommendations. Disinfect used products and samples, or place in a sealedwaste bag, before discarding in household waste.
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