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According to foreign media reports,A new report recently stated that the first batch of COVID-19 tests from the Centers for Disease Control and Prevention (CDC) had a high failure rate. Research results leaked by the agency showed that up to a third of the tests may have failed.At the time of disclosure, there were more than 106,000 new cases of newly diagnosed crowns in the United States in a single day, and the total number of deaths currently exceeds 233,000.
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Although the test kits are available internationally, the US CDC is still working hard to develop its own version in the early stages of the epidemic. However, this did not go as planned. Public testing agencies don’t just have to wait for the CDC kits, when they finally arrived in early February, a problem soon appeared. After verification, the kit reagents did not play their part at all. The chemical reagents did not verify the analyzed samples, but gave uncertain results.
The US Centers for Disease Control and Prevention were forced to return to the lab to redevelop the COVID-19 test kits. However, during this time, the number of new crown boxes in the country has increased. Now, in the internal CDC review that NPR has seen, it has been revealed exactly what went wrong and how many failures in those initial diagnostic tests.
These diagnostic methods were developed according to specific protocols created by the US Food and Drug Administration (FDA), but the respiratory disease laboratories responsible for these kits did not adhere to them. “The absence or failure of document control to ensure that the use of a single verification of the correct test quality control program that matches the program (emergency use authorization) resulted in defects,” the review emphasized.
In fact, according to the report, only at the end, when the kit is actually packaged and ready to be shipped to the test site, is the proper EMA verification completed. They show that the system is far behind. “The first round (quality control) of the final release of the kit used an ‘incorrect’ testing procedure,” the report says. “At the end of the timeline, 33% of failed kits were detected,” use of the correct quality control protocol “did not result in kit recalls or performance alarms.”
However, CDC Labs did not cancel the rollout, instead continuing to distribute. Only when the first batch of third-party verification tests started to run into problems did the agency admit there were problems with its kits.
The FDA insisted in late March 2020 that it should not be responsible for the detection bottleneck. At the same time, the US Department of Health and Human Services (HHS) is currently investigating the failure of the first batch of tests. It is unclear when it will be announced.
Going forward, the US Centers for Disease Control and Prevention will ensure that new measures are in place to ensure that COVID-19 testing situations like this do not reoccur. This includes new standards, test suites to be evaluated, etc. to ensure that they can be implemented in any public laboratory.
