As we all are aware, the FDA declared a healthcare emergency that calls for Emergency Use Authorization of medical devices and inVitro diagnostics that could be helpful in managing COVID – 19.
FDA issued EUA to this device based on the following criteria:
- No adequate, similar approved alternative for the test available
- SARS CoV-2 virus can cause serious life-threatening conditions or diseases to humans
- Reasonable scientific evidence which may be effective in diagnosing COVID – 19
Abbott stated that the company stands with humanity to fight against the SARS CoV-2 by claiming Emergency Use Authorisation (EUA) for its device – Abbott RealTime SARS-CoV-2 assay, which is now authorized by the FDA. Even though the test can be completed within 3 hours, due to an increase in volume, the test results are disclosed within 1-2 days of collecting samples and running the test on them
This device is used to perform tests on the nucleic acids received from nasopharyngeal (NP) and oropharyngeal (OP) swabs from patients suspected of COVID – 19 by their healthcare provider. All these tests are conducted by laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform highly complex tests.