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Abbott ID Now testing update

27 Sep 2020

FDA releases study on test with lower sensitivity methods

By: Karl Kamper, Director, Laboratory Services

Last Friday, the FDA released a study that compares SARS-CoV-2 (COVID-19) diagnostic tests sensitivity levels. This study concluded the Abbott ID Now has a lower sensitivity than other methods performed by Salem Health Laboratories. Abbott Diagnostics updated the FDA authorized intended use of this test to be for symptomatic patients, within seven days of symptom onset. Our internal data demonstrated a 95% correlation between samples previously tested with another method and compared on the Abbott ID Now SARS-CoV-2 test. While a decreased sensitivity can lead to false negatives, the study does not change our understanding of the test’s utility.

The few changes to note based on this outcome:

  • The primary use of the Abbott ID Now is with symptomatic patients, within seven days of symptom onset
  • Providers may continue to use the Abbott ID Now outside of the intended use to test asymptomatic patients for pre-surgical or obstetric admission, as the incidence of asymptomatic COVID-19 infection has been demonstrated to be very low in this population.
  • Providers may also need to continue use of the Abbott ID Now to test asymptomatic patients in an outpatient setting for travel or clearance testing, until timely access to a more sensitive test is available (within 48 hours).