The known limitations of the Covid-19 Antigen Rapid Test are:

  • The Covid-19 Antigen Rapid Test is for in vitro diagnostic use only. The test should be used for the detection of Covid-19 antigens in nasal swab specimens only. The intensity of the test line does not necessarily correlate to Covid-19 viral titer in the specimen.
  • Specimens should be tested as quickly as possible after specimen collection and at most within the hour following collection.
  • Use of viral transport media may result in decreased test sensitivity.
  • A false-negative test may result if the level of antigen in a sample is below the detection limit of the test or if the sample was collected incorrectly.
  • Test results should be correlated with other clinical data available to the physician.
  • A positive test result does not rule out co-infections with other pathogens.
  • A positive test result does not differentiate between SARS-CoV and Covid-19.
  • A negative test result is not intended to rule out other viral or bacterial infections.
  • A negative result, from a patient with symptom onset beyond seven days, should be treated as presumptive and confirmed with a molecular assay, if necessary, for clinical management.
  • If the differentiation of specific SARS viruses and strains is needed, additional testing is required.

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