Our ID NOW test for COVID-19 is the fastest molecular point-of-care rapid test available today and has been delivering reliable results when and where they're needed.
The availability and ease-of-access of ID NOW, which delivers results in minutes rather than a day or more, is helping to reduce the spread and risk of infection by diagnosing COVID-19 in society by detecting more positive results than would otherwise be found.
We're seeing studies being conducted to understand the role of ID NOW in ways that it was not designed to be used. In particular, the NYU study results are not consistent with other studies.
An interim analysis of a study examining ID NOW’s performance in urgent care clinics shows ≥94.7% in positive agreement (sensitivity) and ≥98.6% negative agreement (specificity) when compared to two different lab-based PCR reference tests. Those early results, part of two ongoing multi-site clinical studies, are happening in the real-world situations found in urgent care clinics and strongly suggest ID NOW — which delivers results in minutes, not days — performs best when people are tested earlier after they first experience symptoms.
While we understand no test is perfect, test outcomes depend on a number of factors including patient selection, specimen type, collection, handling, storage, transport and conformity to the way the test was designed to be run. ID NOW is intended to be used near the patient with a direct swab test method.
It is our responsibility to provide healthcare professionals and the public with accurate information, and that's why we're doing the following:
- Further clarifying our product information to provide better guidance to healthcare providers that negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. Negative results should be presumed negative, but if inconsistent with clinical signs and symptoms or necessary for patient management, should be tested with an alternative molecular assay. We are also reinforcing proper sample collection and handling instructions. We are communicating this to our customers.
- Continuing to optimize this test as the world learns more about this virus. We're working to incorporate those learnings into the test as we do with all of our diagnostics tests. Abbott has been working in collaboration with FDA throughout the emergency use authorization (EUA) process.
The world needs a variety of tests in labs and at the point of care if we are to help reduce the spread and risk of infection by diagnosing COVID-19. ID NOW is an important tool in that equation. Helping people is the goal, which is why we're developing and continually optimizing as many tests as we can across all of our diagnostics platforms.
What Others Are Saying
From those using ID NOW for real-world testing as well as the view from those who understand diagnostic testing best:
"Our experience has been that the Abbott tests are catching the sick people and that they are not having any significant false-negative rates," Detroit Mayor Mike Duggan told the Detroit News. "We're entirely confident."
In a segment on some of the latest coronavirus developments and in response to the FDA statement concerning ID NOW, CBS News medical contributor Dr. David Agus stated (timestamp 1:21) "The company has said that NYU did it wrong and there's some methodology issues. What I do know is that every test has false negatives. It's not because necessarily the technology is bad. But it's because there may not be virus in the nose and the mouth when you put a swab in. We do it there because that's where droplets come out. But they may be elsewhere in the body at a very low level. So it’s in a sense not the technology’s fault but the biology. And so we’re never going to get a test that will tell us 100% if there's virus if we’re only looking in those two areas at the present time."
Physicians Immediate Care Senior Medical Director Dr. Warren Wollin told Fox Business's Stuart Varney that he has confidence in ID NOW and its COVID-19 testing for use at his 43 clinics in the Midwest. "We've been using the Abbott COVID-19 test now for almost seven weeks and I feel very confident in its accuracy," Wollin said. "I saw the NYU study that came out. I believe that it’s an anomaly. ... The NYU study did not do point-of-care testing, it was a very small sample size and it wasn’t peer quality reviewed."
And on CNN, John R. Hackett Jr., PhD, from Abbott’s Diagnostics business, said the NYU study is an "outlier."
"The New York study — and this is not a peer reviewed publication — at this point they've posted their study so there hasn’t been a quality review on the study itself," Hackett told Wolf Blitzer (timestamp 1:20). “It is really an outlier relative to other studies that have been published as well as the feedback we're getting from the real world. And when I talk about real world, this is the hundreds of testing sites that are in hospitals, mobile units, municipalities, urgent care clinics, a variety of different settings that are utilizing this test on a regular basis. Their feedback — as long as the test is run properly — is that the results are very effective and they see tremendous value in this."
Hackett, an expert in infectious disease and diagnostic testing, pointed to other studies that have shown much different results when compared the NYU numbers.
"And, in the same week, Dr. Po Tu from the Everett Clinic in Washington, he presented data on a study that he has going there he had 91% sensitivity and 100% specificity," Hackett said. "Now, this is far more in line with the other published studies. And so again, it indicates that there is something going on with this NYU study. It is clearly an outlier from data that’s been seen in general."
This story was originally published on May 19, 2020. It was updated to include reference to our announcement on interim clinical study data on ID NOW COVID-19 rapid test.
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.