The Texas Cardiac Arrhythmia at St. David's Healthcare wants to ensure that our testing and treatment of patients is of the highest quality, and the health and safety of our employees and those who come to us for care is our primary concern.
When we observed recent media reports about a non-peer reviewed article that received significant media attention and questioned the effectiveness of Abbott's ID NOW rapid COVID-19 test, we thought it important to communicate with our communities about our experience with this test, which we continue to use as one tool to diagnose COVID-19 in our hospitals.
Prior to using Abbott's ID NOW test in our hospitals in April, we conducted internal validations, which exceeded those recommended by the manufacturer. In order to make sure this new tool was of the highest quality before its use, we compared ID NOW to other PCR laboratory platforms. Our validation included the use of nasopharyngeal swab specimens, which we use to test all patients at our hospitals. Our results showed that of the 46 patient specimens that were positive on other platforms, 45 were positive on ID NOW which means a positive correlation of 97.8%. Similarly, of the 58 patient specimens that were negative on other platforms, all 58 were negative on ID NOW, which means a negative correlation of 100%.
"The health and safety of our patients, caregivers and our employees are our highest priority," said Andrea Natale, MD, Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David's Medical Center. "We want our community to know that we take great care in evaluating the tools we use to diagnose and treat our patients and have confidence in the continued use of the ID NOW rapid test in our hospitals."
TCAI will continue to monitor FDA and Abbott guidance and will retest patients if the results don't match clinical symptoms as we would do in any situation.
We remain diligent in our fight against coronavirus (COVID-19). The precautions we've taken and the new protections we've put in place make our clinical care facilities one of the safest places possible to receive healthcare at this time. Urgent healthcare needs, including those unrelated to COVID-19, should not be ignored during this time. We are here for you, and we are well-equipped to handle any health concern you may have.
Texas Cardiac Arrhythmia Institute
Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center is one of the world's preeminent centers dedicated to the latest treatment advances for correcting abnormal heart rhythms such as Atrial Fibrillation (A Fib). The center is led by Executive Medical Director Andrea Natale, MD, a world-renowned expert in the field. Natale is at the forefront of advancing treatment for A Fib, leading numerous clinical trials and participating in the development of new technologies and procedures.