Abbott Response to April 23rd Kaiser Health News Story

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Diagnostics Testing | Apr. 23, 2020

Abbott's response to April 23rd Kaiser Health News story, "Abbott's Fast COVID Test Poses Safety Issues, Lab Workers Say":

There is no merit to assertions that the ID NOW testing process is unsafe or endangers operators. Clinicians and lab professionals have been using the same ID NOW sample receiver since 2014 to detect flu, strep, and RSV, and we've never had a complaint about operator contamination.

The sample receiver is not a contamination risk because the sample receiver is only about one-quarter full of liquid reagent. Based on the low volume within the sample receiver, you do not generate a "splash" when mixing a swab in the sample receiver. An operator using ID NOW would have to make a deliberate effort to generate a “splash” and under normal circumstances splashing and splattering does not occur. The virus does not survive because the solution in the sample receiver is acidic, it includes a detergent, and the solution is heated to 56°C (132.8°F). The combination of these three factors inactivates the virus by breaking down the virus membrane. The test then detects the RNA of the virus, which is freed when the membrane breaks down.

The practice of collecting a sample with a swab and placing the swab back into the wrapper is not unique to ID NOW and we have not received any complaints related to this process. Other point-of-care testing platforms used to detect infectious disease also use this method, including for COVID-19.

Collecting and processing samples should follow sterile techniques outlined by CDC guidelines. These techniques are not unique to ID NOW and are well established.

Abbott has been working with the FDA and CDC every step of the way as we've brought three COVID-19 tests to the front lines. When we need to clarify or update guidance on the use of our tests, we do so quickly and transparently.