Some coronavirus testing kits are defective, CDC says
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Some of the coronavirus testing kits shipped to states from the Centers for Disease Control and Prevention (CDC) in an effort to speed diagnoses are defective, a top official with the federal agency said on Wednesday.
The CDC sent the kits to state laboratories across the country last week. Previously, states with suspected cases of the virus would send respiratory secretions, namely nasal or oral swabs, to the agency’s headquarters in Atlanta for testing, forcing state officials to await the results before confirming a case.
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During trial runs in some states, the kits resulted in “inconclusive” results, Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases, said at a news conference on Wednesday. The inconclusive results were not related to real patient samples but rather were a part of “quality-control procedures” at the labs before real samples can be tested.
“Obviously, a state wouldn’t want to be doing this test and using it to make clinical decisions if it isn’t working as well, as perfectly, at the state as it is at [the] CDC,” she said, adding the problem was linked to a certain ingredient in the test, as per The New York Times.
All states received testing kits — which can test between 700 and 800 patient samples, officials have previously said — but it’s not currently clear which states have reported faulty ones.
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The CDC is now sending all states a new supply of the ingredient linked to the flawed kits, regardless if health officials have reported issues with them or not.
The news comes after a labeling issue was to blame for the accidental release of a coronavirus patient who was on her way back to Marine Corps Air Station Miramar in San Diego to join other quarantined evacuees when officials found out her test was positive. The woman, who was not identified, arrived last week on a State Department-chartered flight from Wuhan, the epicenter of the deadly outbreak.
The woman was one of four individuals who was transported from the base to UC San Diego Medical Center for observation after developing possible symptoms of coronavirus. Initially, officials said that all four individuals tested negative for the illness, however, the woman’s sample wasn’t included in the initial test batch. The labeling mix-up was not related to a faulty test kit.
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“At the time, they were relying on phone conversations to relay test results and the CDC in Atlanta told officials in San Diego that all tests were negative,” a CDC representative said on Tuesday. “The problem was because of differences between San Diego labeling and what the CDC lab accepts, the sample from the woman didn’t even reach testing stage so it was true that all samples that were tested were negative, and it was also true that the woman had COVID-19 [coronavirus] because her sample was not tested.”
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The official said the hospital and CDC have since discussed protocol in “excruciating detail” to ensure that the same mishap doesn’t happen again.
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The U.S. now has 15 confirmed cases of coronavirus. Overall, more than 60,000 people have been sickened globally while 1,370 have died.
Fox News' Alexandria Hein contributed to this report.