Limitations and Precautions

Limitations for MEDsan’s SARS-CoV-2 Antigen Rapid Test:

  1. This test is suitable for testing human nasopharyngeal and/or oropharyngeal secretion. This test kit is not intended to be used for other body fluids and samples.
  2. The test results should be used in combination with the clinical examination, medical history, and other examination results.
  3. A negative result for an individual indicates the absence of detectable SARS-CoV-2 antigens. A negative test result does not preclude the possibility of exposure to or infection with SARS-CoV-2.
  4. A negative result may occur if the quantity of the SARS-CoV-2 antigens present in the specimen is below the detection limits of the assay.
  5. Positive test results do not rule out co-infection with other pathogens.
  6. Positive test results do not differentiate between SARS-CoV and SARS-CoV-2.
  7. Negative test results are not intended to rule out other non-SARS viral or bacterial infections.
  8. Optimal test performance requires strict compliance with the test procedure described in this instructions for use. Deviations may lead to aberrant results. Incorrect specimen volume may lead to invalid test results.
  9. Do not keep your prepared sample solution longer than for 60 minutes. This may lead to false test results.

Limitations for MEDsan’s Multiplex SARS-CoV-2 & Flu A/B Rapid Test:

  1. This test is suitable for testing human nasopharyngeal and/or oropharyngeal secretion. This test kit is not intended to be used for other body fluids and samples.
  2. The test results should be used in combination with the clinical examination, medical history, and other examination results.
  3. A negative result for an individual indicates the absence of detectable influenza A/influenza B/SARS-CoV-2 antigens. A negative test result does not preclude the possibility of exposure to or infection with influenza A/influenza B/SARS-CoV-2.
  4. A negative result may occur if the quantity of the influenza A/influenza B/SARS-CoV-2 antigens present in the specimen is below the detection limits of the assay.
  5. Positive test results do not rule out co-infection with other pathogens.
  6. Positive test results for SARS-CoV-2 do not differentiate between SARS-CoV and SARS-CoV-2.
  7. Negative test results are not intended to rule out other non-influenza A/influenza B/SARS viral or bacterial infections.
  8. Optimal test performance requires strict compliance with the test procedure described in this instructions for use. Deviations may lead to aberrant results. Incorrect specimen volume may lead to invalid test results.
  9. Do not keep your prepared sample solution longer than for 60 minutes. This may lead to false test results.

Limitations for MEDsan’s COVID-19 IgG/IgM Rapid Test:

  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.

Warnings and Precautions

  • The test kits are for business use only.
  • MEDsan’s SARS-CoV-2 Antigen Rapid Test and Multiplex SARS-CoV-2 & Flu A/B Tests must be administered by trained healthcare professionals.
  • Do not use after expiration date.
  • The package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results.
  • Do not use if the pouch is damaged or broken.
  • Tests are for single use only. Do not re-use under any circumstances.
  • 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.
  • We suggest wearing protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
  • Humidity and temperature can adversely affect results.
  • Do not perform the test in a room with strong air flow, i.e. electric fan or strong air-conditioning.