The medical community's understanding of coronavirus grows each day, from our knowledge of the SARS-CoV-2 virus to how healthcare providers are helping patients who have been infected.
The same is true for testing.
From development to manufacturing to researchers validating our tests in the field, we continue to learn how best to tackle this virus.
The ID NOW molecular platform is typically found in urgent care settings, emergency departments, physicians' office labs and retail pharmacy settings. Here, healthcare workers are able to take swabs directly to the instrument in real time, yielding results in 13 minutes or less.
With the development of our COVID-19 test for ID NOW, the need for rapid testing is bringing our instrument into new areas of use.
We have learned that some hospital and academic laboratories were using a lab method called viral transport media (VTM) while they validated the new test. A viral transport media is a liquid solution used to store, preserve, and transport a virus sample. Others may have been storing samples for a period of time if they were not near the patient when testing. We encourage lab directors to use ID NOW as it is intended and was designed, which is near the patient. It is possible to deliver quality results and control in a point-of-care setting.
"What we've learned is that this method can reduce the sensitivity of the test through dilution, which could potentially lead to false negative results," said Norman Moore, Ph.D., director of Scientific Affairs for Infectious Diseases, Rapid Diagnostics, Abbott. "While we have only been made aware of a very small number of false negatives, we quickly updated our product information, in consultation with the FDA, and informed our customers to ensure ID NOW is used with a direct swab method to produce the best results."
In response, we issued new guidance on testing directly from the patient using the direct swab method. We were able to make this update quickly thanks to the ongoing dialogue we have with our customers.
Imagine a bowl of water and salt
An elementary school science experiment may help this make better sense. Imagine sticking your finger in a bowl of salt and licking your finger. The salt crystals are fresh on your finger and the taste is strong. This is similar to a "direct swab" method that a healthcare professional would typically use for the ID NOW platform, such as a flu test.
Now imagine taking that same finger and adding it to a cup of water, swirling it around and then placing the cup in the refrigerator. When you come back to drink it, you may detect a slight salty taste but it’s become diluted.
To optimize results, we've asked clinicians and lab professionals to not use VTM. We are confident that the direct swab method will ensure the test performs as expected.
"We understand how important it is to healthcare workers and to the people receiving the test that they have reliable test results," Moore said. "By only using the direct swab testing method, healthcare workers can have continued confidence to make decisions for their patients’ health."
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 the authorization is terminated or revoked sooner.