View Limitations and Precautions

Warnings and precautions

  1. The test kit is recommended for professional use (which is obligatory for use in Switzerland). Do not use after expiration date.
  2. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results.
  3. Do not use if the pouch is damaged or broken.
  4. Test is for single use only. Do not re-use under any circumstances.
  5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.
  6. We suggest wearing protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
  7. Humidity and temperature can adversely affect results.
  8. Do not perform the test in a room with strong air flow, i.e. electric fan or strong air-conditioning.

Limitations

    1. Use fresh samples whenever possible. Frozen and thawed samples (especially repeatedly) contain particles that can block the membrane. This slows the flow of reagents and can lead to high background color, making the interpretation of results difficult.
    2. Optimal assay performance requires strict adherence to the assay procedure described in this insert sheet. Deviations may lead to aberrant results.
    3. A negative result for an individual subject indicates absence of detectable anti-COVID-19 antibodies. However, a negative test result does not preclude the possibility of exposure to or infection with COVID-19.
    4. A negative result can occur if the quantity of the anti-COVID-19 antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected.
    5. Some specimens containing unusually high levels of heterophile antibodies or rheumatoid factor may affect expected results.
    6. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test but should only be made by the physician after all clinical and laboratory findings have been evaluated.