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UK Healthcare says software flaw led to several false-positive COVID-19 tests

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Posted at 9:29 AM, Jul 23, 2020
and last updated 2020-07-23 20:29:50-04

LEXINGTON, Ky. (LEX 18) — UK HealthCare says 26 COVID-19 test results were incorrectly shown as positive due to a software flaw in one of the testing platforms.

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.

The test results impacted by the defect were processed between June 27 and July 16. 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.

"Every system is going to have some false positive and negative because also, there is a range of results," said UK Executive Vice President for Health Affairs Dr. Mark Newman. "When you look at, you know, the relative amount of virus that you see some of them are very high and are obvious. Some of them are very low and are obvious and there's some that we would probably even call in-determined, they're at a level where we can't make a call and in those cases, we would usually ask somebody to retest."

UK HealthCare says they are working with local health departments and the Kentucky Department of Public Health to correct all data.

"We identified this problem and it's fixed going forward because we will redouble again or duplicate and retest on other platforms all positives going forward, Newman said. "But from that standpoint, we wanted to make sure that people knew that they are getting accurate results. We are able to test people well and if they need testing they need to go ahead and get it."