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UK Healthcare finds 26 false-positive COVID-19 tests

Laboratory scientists at the University of Kentucky say the false-positive results were due to a software flaw.

LEXINGTON, Ky. — UK HealthCare has identified 26 COVID-19 test results that were incorrectly shown as positive.

They say the results were shown as positive due to a software flaw in one of the testing platforms. 

According to UK HealthCare, laboratory scientists at the university were inspecting and reviewing raw data from a Thermo Fisher testing platform.

The employees became concerned about discrepancies between the raw data and the software interpretation that might result in false positives.

The Thermo Fisher 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.

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.

“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.”

Currently, all positive results are being confirmed utilizing a different platform prior to release of results.

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