Abbott Statement on Study in Pima County, Arizona

Diagnostics Testing|Jan.19, 2021

BinaxNOW is great at finding infectious people – and this Pima County study demonstrates that BinaxNOW is 92.6% effective at identifying infectious people who are symptomatic and 78.6% when they are asymptomatic. Equally as important, these data show that if a patient has no symptoms and they have a negative result, BinaxNOW will give the right answer 96.9% of the time.

Additionally, the study authors conclude that BinaxNOW facilitates earlier isolation of infectious people and that rapid antigen tests are an important tool to reduce community transmission.

These results are in line with our performance data, which shows performance of 95.6% sensitivity in people seven days or less post-symptom onset, which is the approved indication for use of BinaxNOW.

In our latest clinical data shared with the FDA, which included analyses of people by days post-symptom onset and Ct counts, results showed that BinaxNOW delivered the following performance as compared to lab-based molecular PCR tests:

  • Overall performance of 84.6% positive agreement (sensitivity) and 98.5% negative agreement (specificity) in people seven days or less post-symptom onset at all Ct counts.
  • Performance of 95.6% positive agreement (sensitivity) in people seven days or less post-symptom onset with Ct counts of 33 or below. These are people who are most likely to be infectious and spread the virus to others due to their lower Ct values.
  • Abbott also conducted multiple culture studies that consistently showed that Ct counts less than or equal to 30 are required to grow the virus in a lab.

Other independent third-party studies have identified that higher Ct counts are correlated with a lack of infectiousness, and a rapid antigen test with high performance at a Ct count of 33 or below is able to detect the virus in people who are infectious. Various third-party studies that segment by Ct counts reliably show BinaxNOW with performance in the 90s.

During a pandemic, having a rapid antigen test like BinaxNOW gives the patient critical information at a point in the infection cycle when they’re at the highest risk of spreading disease – making it a powerful tool in preventing transmission compared to a 24-hour turnaround PCR test.