In particular, users in laboratories encountered problems with these tests when they did not apply the recommended positivity threshold — this can result in either false negative results if the threshold applied is lower or false positives if threshold is higher.
This EUA will remain in effect meaning this test can be used for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA after which the test may no longer be used.
Based on the results of a clinical study where the iHealth® COVID-19 Antigen Rapid Test was compared to an FDA authorized molecular SARS-CoV-2 test, iHealth® COVID-19 Antigen Rapid Test correctly identified 94.3% of positive specimens and 98.1% of negative specimens.
Invalid. You were recently tested for COVID-19. The test has been run at Children’s Hospital of Philadelphia's lab, and the results have come back INVALID. Please note that this is a PCR test or a lab-based test that performs similar to a PCR test. This means that we could not determine if your result is positive or negative for COVID-19.
You will get your test result by text message. You cannot use a HSE COVID-19 (coronavirus) test result for international travel from Ireland. If you need a letter for travel, you need to have a negative PCR test from a private company. They will give you the letter you need to travel. Read government advice on international travel
Prior to this update, the CoVerified app placed invalid results and non-performed tests under the same category of “inconclusive.” However, the Barnard Covid Testing Center wanted to provide more specific records, clarifying if a student’s test would come back TNP (“test not performed”), invalid, or inconclusive.
Based on the results of a clinical study where the BD Veritor™ At-Home COVID-19* Test was compared to an FDA emergency use authorized high-sensitivity molecular SARS-CoV-2 test, the BD Veritor™ At-Home COVID-19* Test identified 84.6% of positive specimens and 99.8% of negative specimens.
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