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Update, Feb. 29, 2020: On Saturday, the FDA announced an “accelerated policy … to achieve more rapid testing capacity in the United States,” allowing academic hospital labs capable of performing high-quality testing to develop and begin using their own tests to detect COVID-19. Before now, hospital labs weren’t sent test kits by the CDC and the FDA required an extensive review process even if the hospitals had internally validated their tests. Under the new policy, the FDA review will still be required, but labs will be able to start using their diagnostics once they are internally validated. On Saturday, officials in Oregon and Washington state said they had found new cases of COVID-19 that appeared to be instances of “community spread,” where the source of infection is unknown.
As the highly infectious coronavirus jumped from China to country after country in January and February, the U.S. Centers for Disease Control and Prevention lost valuable weeks that could have been used to track its possible spread in the United States because it insisted upon devising its own test.
The federal agency shunned the World Health Organization test guidelines used by other countries and set out to create a more complicated test of its own that could identify a range of similar viruses. But when it was sent to labs across the country in the first week of February, it didn’t work as expected. The CDC test correctly identified COVID-19, the disease caused by the virus. But in all but a handful of state labs, it falsely flagged the presence of the other viruses in harmless samples.
As a result, until Wednesday the CDC and the Food and Drug Administration only allowed those state labs to use the test — a decision with potentially significant consequences. The lack of a reliable test prevented local officials from taking a crucial first step in coping with a possible outbreak — “surveillance testing” of hundreds of people in possible hotspots. Epidemiologists in other countries have used this sort of testing to track the spread of the disease before large numbers of people turn up at hospitals.
Read more here. (Pro Publica)
As the highly infectious coronavirus jumped from China to country after country in January and February, the U.S. Centers for Disease Control and Prevention lost valuable weeks that could have been used to track its possible spread in the United States because it insisted upon devising its own test.
The federal agency shunned the World Health Organization test guidelines used by other countries and set out to create a more complicated test of its own that could identify a range of similar viruses. But when it was sent to labs across the country in the first week of February, it didn’t work as expected. The CDC test correctly identified COVID-19, the disease caused by the virus. But in all but a handful of state labs, it falsely flagged the presence of the other viruses in harmless samples.
As a result, until Wednesday the CDC and the Food and Drug Administration only allowed those state labs to use the test — a decision with potentially significant consequences. The lack of a reliable test prevented local officials from taking a crucial first step in coping with a possible outbreak — “surveillance testing” of hundreds of people in possible hotspots. Epidemiologists in other countries have used this sort of testing to track the spread of the disease before large numbers of people turn up at hospitals.
Read more here. (Pro Publica)
