A false positive is defined as when someone is actually negative for a target, but the diagnostic test measures this person as positive for the target. All tests have a false positive rate, and it’s expected that this rate should be as low as possible.
This report from Connecticut is very curious, indeed (links below). Out of 144 tests that were deemed positive, only 54 (38%) of those were real positives and 90 (62%) were actually negative (false positive).
Scientists at Connecticut’s public health laboratory identified that a test produced by Thermo Fisher Scientific was connected to these false positive results. This test is being used in many labs around the US. It has been reported to the FDA and to Thermo Fisher Scientific, with no explanation for the cause as of yet.
It’s curious because there is always a negative control included in these tests. The negative control serves to rule out positive results stemming from contamination. To reach this high false positive rate, some type of contamination must have been introduced into the sample tubes, but not the negative control tube. Or, this is an error in processing or coding, and the test is fine.
Either way, this puts a lot of tests into question if they can’t identify the root cause and show that this root cause isn’t indicative of a more systemic problem with the test, processing, or reporting. Is this issue with false positives a localized, limited problem, or is it more systemic in nature? This current report certainly raises some flags to take a more in depth look.
Dr. Albert Ko, a Yale University epidemiologist, said the Thermo Fisher test is widely used by commercial labs throughout the nation.
“I think this situation requires a special call out or shout out to the people at the state health laboratory, (to) Dr. Razeq and his group, because what they found is actually a systemic problem with Thermo Fisher,” Ko said. “So Connecticut here picking it up not only helps the issues of people in the nursing homes, but it also helps people all over the country who are using that test.”
This latest story comes on the heels of a report that discovered that the earliest kits produced to diagnose SARS-CoV-2 were most likely contaminated by the CDC by improper lab practices:
“The test kits for detecting the nation’s earliest cases of the novel coronavirus failed because of “likely” contamination at the Centers for Disease Control and Prevention, whose scientists did not thoroughly check the kits despite “anomalies” during manufacturing, according to a new federal review.” – Washington Post (Linked below)
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