The results demonstrated that ID NOW test has 94.7% performance in sensitivity and 98.6% specificity compared to lab-based PCR reference methods
US President Donald Trump displays a COVID-19 testing kit from Abbott Laboratories. (Credit: The White House from Washington, DC/Wikipedia.)
Global healthcare company Abbott has unveiled interim results from an ongoing clinical study of its ID NOW Covid-19 rapid test in urgent care clinics.
In the study, the company’s Covid-19 test has showed agreement with most of the lab-based molecular polymerase chain reaction (PCR) instruments.
The results demonstrated that ID NOW test has 94.7% performance in sensitivity (positive agreement) and 98.6% specificity (negative agreement), compared to two different lab-based PCR reference methods.
Abbott rapid diagnostics senior medical director Philip Ginsburg said: “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. 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. This tells us that ID NOW is performing comparable to molecular laboratory tests in detecting the virus.”
ID NOW is a rapid, instrument-based, isothermal system that detects Covid-19
In addition to the ongoing clinical study in urgent care clinics, the two other Abbott-sponsored studies include The Everett Clinic in Washington and an ongoing study of hospitalised and nursing home patients.
The company said that its ID NOW was used in the clinical studies as intended with variations in patient populations based on the number of days a patient was tested after first experiencing symptoms.
ID NOW is a rapid, instrument-based, isothermal system intended for the qualitative detection of infectious diseases, and provides molecular results in minutes, by leveraging isothermal nucleic acid amplification technology.
The clinical study at Urgent Care Clinics enrolled 256 subjects, in which ID NOW has identified 100% positive agreement with 29 of 29 positive samples and 99.6% negative agreement with 226 of 227 negative samples, compared to a lab-based molecular PCR assay.
In addition, Abbott’s molecular test has showed 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.
Physicians Immediate Care senior medical director Warren Wollin said: “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.
“It is a powerful tool for near-patient testing and is essential to us in helping reduce the spread of this virus.”