A software flaw is being blamed for showing a positive COVID-19 test result incorrectly for more than two dozen tests.
University of Kentucky laboratory scientists say they were inspecting and reviewing raw data from a testing platform when they became concerned about discrepancies in the data. They believe the testing platform, Thermo Fisher, which was authorized for emergency use by the FDA, had a software flaw that might result in false positives.
After re-testing the samples using another platform, scientists confirmed that the tests initially reported as positive for COVID-19 were negative. The flaw was only found in one of the four testing platforms that UK's clinical laboratory uses.
Every patient who received incorrect results is being notified about the issue. No negative results changed. UK HealthCare also has notified Thermo Fisher Scientific and the FDA.
"For anyone tested at UK HealthCare, it is important to know that the vast majority of results have not changed," said UK Executive Vice President for Health Affairs Dr. Mark Newman. "Since these very astute employees discovered this issue, we have taken extensive measures to validate each test in question and worked diligently to contact all parties – the vendor, the FDA -- and most importantly, our patients and providers."
UK HealthCare says they are working with local health departments and the Kentucky Department of Public Health to correct all data.
"UK's clinical laboratory has performed more than 30,000 COVID-19 tests since March and only a very small percentage of tests have been affected by this software defect," Newman said. "Anyone who has received test results and has not been contacted this week about re-testing, should be assured their result is correct."
This story originally reported by Jordan Mickle on LEX18.com.