At Abbott, we test, research and validate our products with high rigor. We applied that same approach and expertise when we answered the call to help in the fight against the COVID-19 pandemic.
We knew the need was great and we quickly recognized that testing was going to play a critical role. And while no diagnostic test is perfect, our scientists set out to develop reliable tests by bringing together our top experts and all the expertise we've built over the past 50 years that we've been developing diagnostic tests.
With lives at stake, every moment counted as our scientists set out to develop molecular and antibody tests for the coronavirus. At the onset, Abbott mobilized multiple teams of infectious disease and diagnostic experts – some of the same scientists who worked on our HIV, Zika and flu tests and who have years of experience.
Their challenge: Condense a process that usually takes years down to a matter of weeks.
Their objective: Ensure we produce reliable tests in very compressed timeframes.
Their result? Reliable tests that could be quickly deployed into the hands of healthcare workers. Tests that would make an immediate impact in this unprecedented crisis.
Utilizing Time-Tested Platforms, Adhering to Regulatory Requirements
We strategically developed our COVID-19 tests for Abbott's established, high-quality instruments that healthcare workers were already using in a variety of settings – from high-volume core and molecular laboratories in hospitals to our point-of-care ID NOW platform used in urgent care centers and doctors' offices across the U.S.
Abbott has worked closely with government officials to ensure we met all testing criteria under the FDA's emergency use authorization (EUA) for our five COVID-19 tests (three molecular and two antibody tests).
"We have worked with the ID NOW instrument and tests for that for over three years. We've done hundreds of thousands of tests for flu, strep, RSV so we know that molecular testing, which is what it utilizes, is the gold standard for testing in point of care settings. So we have a high level of confidence around that," notes Stan Blaylock, CEO at Physicians Immediate Care.
Real-World Research to Validate Our Testing
Once you develop a test, the work does not stop there. We collaborate with the medical and research community to help ensure the tests are being used in an appropriate way. This allows us to work together to learn about customers’ experiences in the field – something that is proving critical in this crisis that is like no other. We will also use that real-world experience to improve the next generation of tests we intend to develop.
Abbott has developed tests during a health crisis before. We provided the first FDA-approved HIV test. With HIV, we also knew it was critical to get much-needed tests to healthcare workers – it was another situation with significant health implications. Over time, we improved our tests with each generation based on what we learned from use in the field.
For ID NOW and our other COVID-19 tests, it’s no different. Our scientists have been working with the research community to study and validate our tests in real-world settings.
Our work has continued with studies of ID NOW’s real-world performance to detect COVID-19 in urgent care clinics and among hospitalized and nursing home patients. The interim analysis of the study among urgent care clinics found ID NOW has ≥94.7% positive agreement (sensitivity) and ≥98.6% negative agreement (specificity) when compared to two different lab-based PCR reference tests. These results, while early, strongly suggest ID NOW performs best when patients are tested soon after experiencing symptoms.
"We're using the best COVID-19 tests we have available to us, including ones from Abbott,” said Robert DeCresce, Director Medical Labs, Rush University Medical Center. "These tests have been critical in helping our center work through this health crisis and as we continue to learn more about the disease and testing, I expect the tests will only get better from here."
The Detroit Health Department in collaboration with the Michigan Department of Health and Human Services recently conducted a study to validate the results of ID NOW compared to molecular lab testing. The study showed 98% agreement when running the patient sample on both the ID NOW rapid device and the lab-based molecular instrument. These results confirm that ID NOW is an important tool in its authorized use during this COVID-19 public health emergency.
"Conducting research during a pandemic requires flexibility and being able to adapt to the unknowns of this virus and where patients are showing up for care," said Philip Ginsburg, M.D., senior medical director, Rapid Diagnostics, Abbott. "As hotspots change, we need to expand our research to other locations so we can collect enough patient samples to support robust study findings."
One of the important next steps the medical community will need to understand is how coronavirus presents in both asymptomatic and symptomatic patients and across different patient populations to help doctors provide more specific patient care. Testing will provide the insights and information needed so we can advance healthcare for patients.
We're still in early days of this pandemic. We’re learning more every day and we’re working on developing the next iteration of the COVID-19 test for the ID NOW platform as we focus on ending the pandemic.
This story was originally published on May 4, 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.