On Oct. 7, 2020, in a continuing effort to provide the facts about ID NOW to support public health interests, Abbott shared new interim clinical data results on its ID NOW COVID-19 rapid test. The results confirm the data submitted to the U.S. Food and Drug Administration (FDA) in March for Emergency Use Authorization (EUA) and the interim results that Abbott shared in its May 21 press release. The data also speak to the important role played by reliable point-of-care testing that is available in convenient and accessible locations where people can get immediate results.

Abbott has completed an interim analysis of its ID NOW 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).

These findings are also consistent with a study published in the Annals of Internal Medicine, where researchers from Johns Hopkins found that even the most sensitive lab-based molecular tests can have false negatives when viral load levels are ramping down, near the end of the infection cycle, when viral load decreases and patients may no longer be infectious.