Authors: Gustavo Romero-Velez, MD, David M Pechman, MD, MBA
Abbott received FDA approval for ID NOW™ COVID-19 test on March 27, 2020.
The Abbott ID NOW COVID-19 test runs on the Abbott’s ID NOW™ platform and allows for rapid point of care molecular testing.
Currently, there is worldwide health emergency caused by the coronavirus disease (COVID-19). This is produced by the transmission of novel coronavirus (SARS-CoV-2) which is an enveloped single strand RNA virus from the Coronaviridae family1. The virus causes a mild disease in the majority of the cases, however those with severe disease will develop severe acute respiratory syndrome (SARS) which can lead to death.
Laboratory diagnosis of SARS-CoV-2 has relied on polymerase chain reaction (PCR), which is the gold standard for the diagnosis of an infectious agent2. The assay can take 4 to 6 hours to complete and the time required to deliver samples to a testing facility causes further delay. The ID NOW™ COVID-19 test utilizes isothermal nucleic acid amplification technology which is intended for qualitative detection of the SARS-CoV-2 RNA. This technology amplifies a unique region of the viral RNA. The amplified RNA targets are then identified with fluorescently labeled molecular beacons3. The test is accompanied by a positive and negative control swab and results can be obtained in 5 minutes for positive results and 13 minutes for negative results. The Abbott’s ID NOW™ platform is lightweight (6.6 pounds) and small (8.15” W x 5.71” H x 7.64” D), allowing for convenient placement for point of care testing.
The FDA has not determined this device to be substantially equivalent to predicate devices. The ID NOW™ COVID-19 test received FDA Emergency Use Authorization, pursuant to Section 564 of the Federal Food, Drug and Cosmetic Act given the current public health emergency that COVID-19 confers to the health and security of the United States citizens4.
The ID NOW™ COVID-19 test is approved for direct testing of nasal, nasopharyngeal, and throat swabs from individuals who are suspected to have COVID-19. The manufacture states that when not in use for COVID-19 testing, the device can be used for testing for Influenza A&B, Strep A and respiratory syncytial virus (RSV).
The use of this device is not currently indicated for other procedures not listed above. The device is approved for use under and Emergency Use Authorization only.
- Loeffelholz, MJ, Tang, YW. Laboratory diagnosis of emerging human coronavirus infections – the state of the art. Emerg Microbes Infect.2020 Dec;9(1):747-756. doi: 1080/22221751.2020.1745095
- Sheridan, C. Fast, portable tests come online to curb coronavirus pandemic. Nat Biotechnol.2020 Mar 23. doi: 1038/d41587-020-00010-2
- ID NOW COVID-19. (2020, March 27). Retrieved from https://www.fda.gov/media/136525/download
- Hinton, DM. (2020, March 27). Abbott ID NOW COVID-19. Retrieved from https://www.fda.gov/media/136522/download