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Saturday, March 6th, 2021

CDC rushes to correct coronavirus test following performance issues

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An apparent bottleneck has emerged in U.S. capabilities to test for the novel coronavirus, with the much-awaited release of a Centers for Disease Control and Prevention (CDC) test kit scrapped this week after performance issues emerged.

While this has not hindered the CDC’s testing capabilities, it does mean that the U.S. capacity to rapidly test for COVID-19 at sites throughout the country has been limited. Total confirmed cases of COVID-19 in the United States stand at 59, according to the latest CDC estimates, though this includes 45 citizens repatriated from overseas. That said, the United States has only tested roughly 445 people so far, compared against the thousands being tested elsewhere in the world, as the outbreak shows no signs of slowing.

The fault was owed to a problem in the manufacturing of one of the reagents involved in the test kits, the CDC said. This led to labs being unable to verify test performances and has forced the CDC to remanufacture the reagents with different quality control measures. It plans to reissue tests through the International Reagent Resource once the problem has been solved.

The news broke a mere day after Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, warned of dangers to come for the country in a teleconference.

“It’s not so much of a question of if this will happen in this country anymore but a question of when this will happen,” Messonnier said of COVID-19.

The CDC moved quickly to allay concerns, though the Department of Health and Human Services has asked for an additional $2.5 billion from the Senate to further vaccine development, expand surveillance and bolster the nation’s support system and equipment. The request received much push-back from Democrats, who pointed to the Trump administration’s consistently promoted cuts to the CDC — cuts as recent as the upcoming budget.

“I am frustrated like I know many of you are that we have had issues with our test,” Messonnier said. “I want to assure you that we are working to modify the kit and hope to send out a new version to state and local jurisdictions soon.”

Currently, despite the faulty tests, there remain 12 states or localities that can test samples in addition to the United States.

“There is no current backlog or delay for testing at CDC,” Messonnier said. “Commercial labs will also be coming online soon with their own tests. This will allow the greatest number of tests to happen closer to where potential cases are. Last, I want to recognize that people are concerned about this situation. I would say rightfully so. I’m concerned about the situation. CDC is concerned about the situation. But we are putting our concerns to work preparing.”

Some concerns have been raised that the relatively small number of U.S. cases so far may not show the true picture of the coronavirus spread, but rather, a reflection of currently limited testing. Vice President Mike Pence had been appointed to lead ongoing COVID-19 efforts even as a troubling new case emerged this week in California, where infection was unlinked to any travel abroad or exposure to another patient — and after waiting days for testing.

Globally, the World Health Organization reported that, as of February 26, more than 81,000 cases of the disease had been confirmed in a total of 38 countries, including more than 2,700 deaths.