An ongoing clinical study of the Abbott ID NOW™ COVID-19 rapid test shows strong agreement to lab-based molecular polymerase chain reaction (PCR) instruments.

The Abbott ID NOW COVID-19 test is an automated, molecular point-of-care test that is used to diagnose coronavirus disease 2019 (COVID-19) within minutes, allowing healthcare professionals to make clinical decisions during a patient visit.

The real-world study is evaluating the efficacy of the ID NOW COVID-19 test at 5 urgent care clinics in New Jersey, Tennessee, Louisiana, Texas and South Carolina. Among the 256 patients enrolled; the mean number of days from symptom onset was 4.1 days with 90% of patients tested within 7 days post symptom onset.

Interim results demonstrated ID NOW identified 29 of 29 positive samples (100% positive agreement) and 226 of 227 negative samples (99.6% negative agreement) compared with the commonly-used lab-based molecular PCR assay (the Roche cobas® SARS-CoV-2 assay). 

The urgent care study comes on the heels of a recent FDA announcement suggesting ID NOW produces false negative results. Data from this study are consistent with findings from the Everett Clinic study of 955 patients, which demonstrated ID NOW had 91.3% positive agreement and 100% negative agreement compared with lab-based PCR assays.

Additionally, in comparison with the Centers for Disease Control (CDC) COVID-19 Real-Time RT-PCR Diagnostic Panel, ID NOW showed 94.7% positive agreement (sensitivity) and 98.6% negative agreement (specificity), while the Roche PCR assay had 95.0% positive agreement and 98.7% negative agreement. 

Moreover, interim analysis showed that ID NOW performs best in patients tested earlier post symptom onset.

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“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, DO, 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.”

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