As the first major outbreak of COVID-19 appeared in the United States, scientists at the Centers for Disease Control and Prevention (CDC) in Atlanta quickly developed a diagnostic test that could detect infection. COVID-19.
When the test launches in national laboratories on February 6, it is meant to provide a key step in detecting and preventing new coronaviruses in a standard epidemiological effort to contain block widespread outbreaks. If infection can be found, they can be treated in isolation and exposure tracking would be possible.
NPR report that this effort was hampered when the CDC released the test suite because trials had high failure rates; The first diagnostic tests for COVID-19 are likely to be false 33% of the time. Despite this bleak assessment, the public health agency decided to release the test kit.
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In addition to the early warning of problems with tests, a CDC internal reviewer found problems in the Respiratory Virus Diagnostic Laboratory, including a “bug process, lack of appropriate recognized laboratory quality standards, and problems associated with assisting and managing an outbreak response laboratory. “
The first reports of faulty tests come from New York City Public Health Laboratory officials as the city is shaping up to be a viral hotspot. In the standard procedure to verify the accuracy of the assays, laboratory technicians reported unidentifiable results from the reagents submitted from the CDC, making it impossible to know whether the sample was positive or negative. charged with viruses.
Jennifer Rakeman, director of the New York City Laboratory of Public Health told reporters: “It was really a ‘oh, crap’ moment.” These reagents are not working; people are waiting for us across the city to have this test online. We think we have more cases than we can detect and testing doesn’t work. “
Without functional and accurate tests, people will have a hard time knowing if they are infected with COVID-19 – and leading to the spread of the virus.
Finally, the CDC took note of its faulty tests and public health officials argued that contamination could be the culprit behind inaccurate tests, NPR reports.
After further investigation, poor laboratory procedures, such as researchers dressed the same way in and out of the laboratory and disorganized test components, were observed. These may lead to contamination of the test reagents and chemicals.
More complex problems emerged from the report, including the head of the Respiratory Virus Diagnostic Laboratory, Stephen Lindstrom, constructing a diagnostic test similar to the one he previously created. for other respiratory coronaviruses such as SARS and MERS.
This is inherently not a problem, but mistakes have occurred in laboratory protocols, such as document control to verify test quality. This is very important to secure an Emergency Use Permit from the US Food and Drug Administration for COVID-19 tests. When the quality control tests in the lab showed 33% failures, Lindstrom decided not to recall them, but instead gave them to other laboratories.
An official at the Ministry of Health and Human Services told NPR reporters that the potential failure rate is 33%, so it must be recalled immediately.
“The [quality control] The records showed that the test had problems, “the official said.” Lindstrom signed a clear flawed quality check. He shouldn’t have released that kit. “
Notably, the CDC also did not set any success or failure rates for the first COVID-19 diagnostic test, which made it difficult to estimate an acceptable percentage of failure. .
The NPR reported that Lindstrom did not comment, and the CDC said the agency had “acknowledged and corrected mistakes in the process.”
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