LEXINGTON, Ky. (LEX 18) – UK HealthCare says 26 COVID-19 test results were incorrectly shown to be positive due to a software flaw in one of the test platforms.
Laboratory scientists at the University of Kentucky say they were inspecting and reviewing raw data from a test rig when they were concerned about discrepancies in the data. They believe that the test platform, Thermo Fisher, which was cleared for emergency use by the FDA, had a software flaw that could lead to false positives.
After re-analyzing the samples using another platform, the scientists confirmed that the tests initially reported as positive for COVID-19 were negative. The failure was only found on one of the four test platforms used by the UK clinical laboratory.
The test results affected by the defect were processed between June 27 and July 16. All patients who received incorrect results receive notification of the problem. Negative results were not changed. UK HealthCare has also notified Thermo Fisher Scientific and the FDA.
“Each system will have some false positives and negatives because there are also a variety of outcomes,” said Dr Mark Newman, UK Executive Vice President for Health Affairs. “When you look at, you know, the relative amount of viruses that you see, some of them are very high and they are obvious. Some of them are very low and they are obvious and there are some that we would probably call even certain. We are at a level where we can’t make a call and in those cases we generally ask someone to retest. “
UK HealthCare says they are working with local health departments and the Kentucky Department of Public Health to correct all the data.
“We identified this issue and it is fixed in the future because we will re-double or duplicate and retest all other positives in the future on other platforms,” Newman said. “But from that point of view, we wanted to make sure that people knew they were getting accurate results.” . We can evaluate people well and if they need proof, they should go ahead and get it. “
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