On May 21, 2020, 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 demonstrated the ID NOW COVID-19 test performance was =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.

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).

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.

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.