U.S. Food and Drug Administration expands usage of coronavirus diagnostic kits

The U.S. Food and Drug Administration (FDA) has granted emergency use approval to state public health laboratories to start testing for China’s coronavirus using kits developed by the Centers for Disease Control and Prevention (CDC).

The approval will help speed up testing for the coronavirus, which has infected 11 people in the country as of February 3, in the United States.

The World Health Organization has declared China’s coronavirus as a global health emergency. Experts say, much of the virus remains unknown including its transmission pathways and how deadly it is.

While earlier, states had to send samples to the CDC for testing, with this approval, state public health labs can order test kits and start the work of validating the tests within their own labs to make sure their scientists are using it correctly, said Scott Becker, executive director of the Association of Public Health Laboratories (APHL).

“It’s not plug and play. They have to make sure a number of lab scientists in their labs are able to make the test work. This has to be right,” said Becker.

Once the labs have the kits, they could commence testing with 5 or 6 days, said Becker. Initially, the labs will also have to send samples to the CDC to confirm their results.

According to Dr Joe Bresee, a CDC epidemiologist who is working on the outbreak response, the kits contain a collection of enzymes that will give labs all of the necessary tools they need to test samples for the virus.

“We hope to send at least one to every state health department and maybe more than one,” said Bresee.

“The agency also hopes to share the kits with countries that may not currently have the ability to do their own testing”, said Bresee while adding, each kit will cover the testing for at least 400 patients.

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