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FDA Revises Emergency Use Authorization for Abbott Point-of-Care SARS-CoV-2 Test

NEW YORK – The US Food and Drug Administration last week released revisions to Abbott Laboratories' Emergency Use Authorization for its point-of-care ID Now test. 

Those revisions include an update to the intended use to clarify that the test is for specimens collected within a week of symptom onset and is authorized for CLIA-certified labs that can perform high, moderate, or waived complexity tests. The intended use was also amended to clarify results reporting requirements for testing facilities.

In addition, the test's labeling was revised with updated specimen transport and storage recommendations and to include the results of FDA's SARS-CoV-2 reference panel testing. The conditions of authorization and fact sheets were also updated to reflect the language of more recent authorizations.

Abbott's automated assay qualitatively detects nucleic acid from viral RNA in nasal, nasopharyngeal, or throat swabs and runs on the company's ID Now instrument, which uses isothermal nucleic acid amplification. The rapid test can return results in less than 15 minutes, according to the Abbott Park, Illinois-based company. 

The test originally received EUA in March and has been updated twice – once in April to remove nasal, nasopharyngeal, or throat swabs eluted in viral transport media swabs as a specimen type, and once in June to indicate negative results should be presumptive and to clarify the test can be used at the point of care.