Post-authorisation study of ID NOW COVID-19 EUA Test confirms results submitted to FDA.- Abbott

Abbott has shared new interim clinical data results on its ID NOW COVID-19 rapid test. The results confirm the data submitted to the FDA in March for Emergency Use Authorization (EUA) and the interim results that Abbott shared in its May 21 press release. In the post-authorization study, a total of 1,003 people were evaluated across two care environments: urgent care clinics (acute care) and hospitals and nursing homes (in-patient care). In these two care environments, the ID NOW delivered the following agreement to lab-based molecular PCR tests: Overall performance of 93.3% positive agreement (sensitivity) and 98.4% negative agreement (specificity). Further, in the 161 patients with high viral titers (Ct <33), and therefore most likely to transmit virus, id now showed performance of 97.0% positive agreement (sensitivity). performance of 95.0% positive agreement (sensitivity) and 97.9% negative agreement (specificity) in subjects within seven days post symptom onset. further, in the 129 patients with high viral titers (ct><33), and therefore most likely to transmit virus, id now showed performance of 98.4% positive agreement (sensitivity). performance of 94.6% positive agreement (sensitivity) and 97.6% negative agreement (specificity) in symptomatic subjects. further, in the 136 patients with high viral titers (ct><33), and therefore most likely to transmit virus, id now showed performance of 97.8% positive agreement (sensitivity). in addition to the post-authorization data, abbott is providing an update to three studies that were covered in its may 21 interim study press release: multi-site urgent care. in a completed analysis from a multi-site urgent care clinical setting of 430 symptomatic patients with two or more symptoms, including 53 pcr positive subjects, id now demonstrated performance of 96.2% in positive agreement (sensitivity) and 99.5% negative agreement (specificity) compared to lab-based molecular pcr tests. everett clinic. in a completed study at the everett clinic in washington of 974 people, including 23 pcr positive subjects, in partnership with yuan-po tu, m.d., id now demonstrated 91.3% positive agreement (sensitivity) and 100% negative agreement (specificity) compared to lab-based molecular pcr tests. in-patient. in an in-patient care study (hospitals and nursing homes), a total of 518 symptomatic patients were evaluated, including 94 pcr positive subjects. id now demonstrated 79.8% positive agreement (sensitivity) and 94.3% negative agreement (specificity) compared to lab-based molecular pcr tests. in the 494 subjects who reported days from symptom onset, the median number of days from symptom onset was 10 days with 71.1% of people presenting>7 days post symptom onset. In 45 patients with high viral titers (Ct <33), and therefore more likely to transmit virus, id now showed performance of 100% positive agreement (sensitivity). in a further analysis of this data, the subset of 143 symptomatic patients within seven days of symptom onset were evaluated, of which 30 were pcr positive. id now demonstrated 86.7% positive agreement (sensitivity) and 96.5% negative agreement (specificity) compared to lab-based molecular pcr testing.>