Abbott announced an interim analysis of an ongoing multi-site clinical study in urgent care clinics that indicates its ID NOW COVID-19 rapid test is showing strong agreement to lab-based molecular polymerase chain reaction (PCR) instruments. The interim results are demonstrating ID NOW COVID-19 test performance is ≥94.7% in positive agreement (sensitivity) and ≥98.6% negative agreement (specificity) when compared to two different lab-based PCR reference methods.
Data from this, as well as two other Abbott-sponsored studies – The Everett Clinic in Washington and an ongoing study of hospitalized and nursing home patients – suggest ID NOW performs best in patients tested earlier post symptom onset, when they are most likely to go for care. In these studies, ID NOW was used as intended with variations in patient populations based on the number of days a patient was tested after first experiencing symptoms.
"We're pleased that ID NOW is delivering on what it was designed to do – quickly detect the virus in people who need to know now if they're infected," said Philip Ginsburg, M.D., senior medical director, infectious disease, Rapid Diagnostics, Abbott. "This is great news for people who are experiencing symptoms and want to take action before they infect others, reducing the spread of infection in society."
"These new interim results reflect what we're hearing from hundreds of our customers, which is that they're seeing results with positive rates from ID NOW that are at, or above, their local COVID-19 infection rates," continued Dr. Ginsburg. "This tells us that ID NOW is performing comparable to molecular laboratory tests in detecting the virus."
In 256 subjects enrolled to date, ID NOW has identified 29 of 29 positive samples (100% positive agreement) and 226 of 227 negative samples (99.6% negative agreement) when compared to a commonly-used lab-based molecular PCR assay (the Roche cobas® SARS-CoV-2 assay).
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In parallel, ID NOW has demonstrated 94.7% positive agreement and 98.6% negative agreement compared to the Centers for Disease Control (CDC) 2019-Novel Coronavirus (COVID-19) Real-Time RT-PCR Diagnostic Panel. In comparison, Roche has demonstrated 95.0% positive agreement and 98.7% negative agreement when compared to the CDC assay.
In these subjects, the mean number of days from symptom onset is 4.1 days with 90% of subjects tested within 7 days post symptom onset, when patients typically show up for care.
"This corresponds to what my colleagues and I are seeing every day when using ID NOW, which is that it combines strong sensitivity and specificity with rapid results so that we can provide immediate information and care," said Warren Wollin, D.O., senior medical director, Physicians Immediate Care, who is not affiliated with this study. "It is a powerful tool for near-patient testing and is essential to us in helping reduce the spread of this virus."
The ongoing study is examining ID NOW COVID-19 test performance at five urgent care clinics (New Jersey, Tennessee, Louisiana, Texas and South Carolina). This is one of the first studies conducted on the ID NOW COVID-19 test in a real-world setting as it is intended to be used, compared with other studies that have used banked or retained samples.