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CDC fixes coronavirus testing kit error, lifts restrictions on patient testing


CDC this week informed state officials that it has fixed a problem with the coronavirus test kits it is sending to state health labs and expanded the agency's criteria for testing patients for the virus.

Our analysis: The 'recurring themes' of disease outbreaks

Background: US coronavirus cases on the rise

Reports of the new coronavirus, known as SARS-COV2, first surfaced in early December 2019 in Wuhan, China. According to the World Health Organization (WHO), the main symptoms of the virus are fever and lesions in both lungs. Some patients also have reported difficulty breathing, WHO said.

As of Friday, officials reported more than 83,700 cases of the virus globally, with most of those cases occurring in mainland China, the New York Times reports. Officials said as of Friday there had been at least 2,858 deaths linked to the virus, and all but 70 of the deaths occurred in mainland China.

In the United States, the Times reports a total of 60 confirmed cases of the virus. However, some states are reporting increases in their case counts. For instance, California Gov. Gavin Newsom (D) on Thursday said 33 people in California have tested positive for coronavirus, including the first suspected case of community spread in the United States. That figure is up from 31 cases the state had confirmed earlier this week, The Hill reports.

Newsom said state officials are now monitoring more than 8,400 people for the virus, adding that the state is working with federal officials to increase the number of testing kits available in the state.

CDC fixes faulty coronavirus tests—updates testing guidelines

In light of the growing number of suspected and confirmed cases in California and around the world, CDC this week took steps to expand access to coronavirus testing kits in the United States.

Currently, only about a dozen state and local laboratories are properly equipped to confirm coronavirus diagnoses in the United States, in part because the testing kits CDC sent to local governments earlier this month included a faulty component.

The problem, which NPR's "Shots" reports involved an ingredient in the test kit, had slowed the United States' ability to test and confirm coronavirus diagnoses, requiring most of the testing to be conducted at CDC's headquarters in Atlanta.

However, CDC on Wednesday informed state officials that the error has been fixed and the agency is sending the new testing kits to state labs.

HHS Secretary Alex Azar said 40 local, state, and Department of Defense labs have already been approved to use the updated testing kits. Azar added that all 93 labs in the United States will have clearance to use the test kit by next week.

CDC on Thursday also updated its guidelines for coronavirus testing in light of the country's first suspected case of community spread identified in California on Wednesday.

Officials at the University of California's Davis Medical Center, where that case is being treated, in an email sent to employees late Wednesday wrote that the staff informed CDC of a possible coronavirus case immediately after the patient had been admitted to the hospital on Feb. 19. However, they noted that CDC did not immediately test the patient for coronavirus because the patient at the time did not fit the agency's criteria for testing patients for the virus—a claim CDC pushed back on this week.

CDC previously restricted testing to individuals who have traveled to China or who have had contact with an individual who had a confirmed case of the virus. But on Thursday, CDC Director Robert Redfield said the agency will allow testing "[w]hen a clinician or public health individual suspects coronavirus" (Stein, "Shots," NPR, 2/27; Wigglesworth/Luna, Los Angeles Times, 2/27; Sullivan, The Hill, 2/27; Feuer/Stankiewicz, CNBC, 2/27).


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