Abbott is providing additional information and direction for clinicians, laboratory professionals, and our customers on our ID NOW COVID-19 rapid test.
Some of our hospital and academic laboratory users have been validating our ID NOW COVID-19 rapid test (part of a lab's normal process) with the use of viral transport media (VTM) samples. VTM is a liquid solution used to store, preserve, and transport a virus sample. This method can reduce the sensitivity of the test through dilution, which can potentially lead to false negative results.
ID NOW is designed for – and typically used within – urgent care clinics, physicians' office labs, emergency departments, and retail settings. This means that patient samples (swabs) are collected and tested directly on the ID NOW instrument, near the patient and without the use of VTM.
In consultation with the FDA, we have instructed our customers not to use VTM for the ID NOW COVID-19 rapid test. The sample (swab) should be placed directly in the instrument for testing and not placed in any other media. We have updated our product information and are directly communicating with our customers.
When a direct swab is used, the test is performing as expected and we have confidence in the performance of the test.
This story was originally published on April 15, 2020 and updated on June 03, 2022.
IMPORTANT SAFETY INFORMATION
The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless theauthorization is terminated or revoked sooner.
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