UK HealthCare Finds Just Over Two Dozen False-Positive COVID-19 Tests
A software flaw leads to a little over two-dozen false positive test results of COVID-19 for UK HealthCare patients. UK says lab scientists were inspecting and reviewing raw Coronavirus testing data last Thursday when they found a possible flaw. The employees became concerned about discrepancies between the raw data and the software interpretation that might result in false positives. It turned out they were right. 26 cases that were processed between June 27th and July 16th and reported as positive were in fact negative. Dr. Mark Newman, UK Executive Vice President for Health Affairs said the patients affected have been notified so if you do not hear from UK HealthCare this week, your results were accurate.
Newman said the number of false positives is a very tiny fraction of the number of tests run, which was just over 30,000 in the time frame the incorrect results were found. (000867%)
Here is a timeline of events released by UK HealthCare Thursday morning.
- On July 16, University of Kentucky laboratory scientists were inspecting and reviewing raw data from the Massachusetts-based Thermo Fisher testing platform which has FDA Emergency Use Authorization.
- The employees became concerned about discrepancies between the raw data and the software interpretation that might result in false positives.
- The laboratory retested the suspect samples using another testing platform and confirmed that the tests initially reported as positive for COVID-19, were in fact negative. UK’s clinical laboratory uses four different testing platforms. The flaw has only been found in one testing platform.
- Since then, UK has reviewed all COVID-19 positive patient specimens tested on the Thermo Fisher testing platform and assessed the accuracy of the results.
- Results with a discrepancy between the raw data and the software interpretation were then retested on a different testing platform. No negative test results changed. However, 26 tests previously identified as positive were confirmed as negative.
- Every patient who received incorrect results is being notified about the issue. UK HealthCare also has notified Thermo Fisher Scientific and the FDA.
- The Thermo Fisher Scientific TaqPath testing platform has been used by UK since June 27. The test results impacted by the defect were processed between June 27 and July 16. Currently, all positive results are being confirmed utilizing a different platform prior to release of results. In total, UK’s clinical laboratory uses four different testing platforms.
Dr. Newman called the mistake an anomoly and gives UK's testing process and results an "overall A." He went on to say that while there are always ways to improve and new discoveries made, he is confident with the system.