LOUISVILLE, Ky. (WDRB) -- UK Healthcare says a software flaw led to 26 people receiving false positive results on their COVID-19 tests.
According to a Thursday morning news release from UK Healthcare, University of Kentucky lab scientists became concerned last Thursday while they were inspecting raw data from a Thermo Fisher testing platform.
"The sample is run, and it gives you raw information — or raw data — and then that raw data is interpreted as either a positive or negative," said Dr. Mark Newman, executive vice president of health affairs at UK. "We noticed what looked like some very low sample results being interpreted by the software as positive."
Thermo Fisher is one of four testing platforms used by UK Healthcare. Newman said all positive tests run through the "flawed" software were reexamined on a different platform exposed the 26 inaccurate results.
"We have communicated with the FDA to let them know — in this case, with this software — we are seeing some false positives," Newman said. "So other people using this technology can look and make sure there aren't issues for them as well."
Thermo Fisher is a $25 billion science company based in Massachusetts. Company officials contend that the issue with false positives were on UK's end likely caused by an error mixing the sample with the extraction agent and not deficiency in the software.
"The test kit includes detailed, FDA-approved instructions for use which must be followed in order to obtain the most accurate results," Rob O'Brien, senior director of public relations for Thermo Fisher, said in an emailed statement to WDRB. "We provide 24-hour support for labs that are processing COVID-19 test kits and strongly encourage lab personnel to participate in training to ensure that tests are being properly processed."
A spokesperson from Gov. Andy Beshear's office said he was not aware of false positive results at any other labs in Kentucky.
The platform in question is Thermo Fisher's TaqPath COVID-19 Combo Kit with Applied Biosytems COVID-19 Interpretative software version 2.2.
Representatives from Baptist Health, University of Louisville Hospital and Norton Healthcare all said their respective organizations did not use it for COVID-19 testing, but it's unclear how many state approved labs do. According to the Kentucky Cabinet for Health and Family Services website, there are 12 labs in the commonwealth used for COVID-19 testing. Only two responded to emails Thursday: BIOTAP Medical based in Louisville and Ethos Laboratories from Newport.
"Our procedure requires scientist review of raw data and does not use the Thermo Fisher interpretive software which appears to have resulted in false positive calls identified at UK Healthcare," BIOTAP Chief Operating Officer Kristen Reynolds said. " The manual review process ensures that BIOTAP Medical results are not subject to the false positive software error."
Representatives for Ethos Laboratories said the company did not use the Thermo Fisher platform at all.
A video posted to the company's website says Thermo Fisher produces more than 5 million of its COVID-19 diagnostic test per week. They're approved in 50 countries, including an FDA Emergency Use Authorization in the United States.
Earlier this week, state officials in Connecticut blamed 90 false positive coronavirus tests on a Thermo Fisher product. Again, company officials rebuffed the claims as lab error. But these inconsistent results come as almost every state in the nation is reporting a surge in positive COVID-19 testing, which has prompted local and state officials to add more restrictions.
Governors of Kentucky and Indiana both signed executive orders making masks mandatory in recent days. Beshear went further in the commonwealth, asking residents to quarantine for 14 days after returning from a state that has a 15% or high positivity rate for COVID-19 tests.
Kentucky reported 611 new infections on Thursday, the state’s fourth-highest daily total since the pandemic began in March.
“This week, we have seen some of our highest number of cases of the coronavirus going all the way back to the start of dealing with this pandemic in Kentucky on March 6,” Beshear said. “These results ought not to make us panic but it also ought to make us get back into the habits that we know help defeat this virus.”
UK Healthcare said its false positive tests were administered between June 27 and July 16, and patients impacted by the mistake are being notified.
Despite the current confusion, Newman said he still has faith in the data as while there are 26 false positives UK has done 30,000 tests.
"If you've gotten a test from us, we're confident in the result," he said.
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