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National

The U.S. Government Is Sharing Its Test For The New Coronavirus

MARY LOUISE KELLY, HOST:

Until now, the only place in the United States that was allowed to test whether people were infected with the new coronavirus was the Centers for Disease Control and Prevention. That is in Atlanta. But last night, the Food and Drug Administration granted emergency authorization for CDC to share its test with public health labs around the country. NPR's Joe Palca has more.

JOE PALCA, BYLINE: Once Chinese scientists published the genetic makeup of the new virus, as they did last month, it was possible to make a reliable test for the virus. The CDC was the first in this country to develop one, but other labs are capable of carrying it out. Kelly Wroblewski is director of infectious diseases with the Association of Public Health Laboratories. She says the CDC has already begun sharing the details of how to run the test with her members.

KELLY WROBLEWSKI: They have been briefed on what sort of equipment and what sort of supplies they'll need. So they've been stocking up on those supplies over the last week.

PALCA: Wroblewski says the public health labs could start running the test as early as next week. Wroblewski says each lab should have the capacity to run hundreds of tests per week, but if it turns out there's a greater need - say, thousands or tens of thousands of tests per week - that could be a problem. At a news conference last week, CDC Director Robert Redfield said something that made people wonder if there might be a problem with the test.

(SOUNDBITE OF PRESS CONFERENCE)

ROBERT REDFIELD: We've seen people who had detectable virus, then they didn't have detectable virus, and then three days later they had detectable virus.

PALCA: So is the test reliable? Kelly Wroblewski says, almost certainly, yes.

WROBLEWSKI: There's a couple of things that could happen.

PALCA: She says a sample with no detectable virus might have come from a place in the nose or throat that might not happen to have virus present.

WROBLEWSKI: The other thing that can happen is there are differences in the level at which a virus is being excreted on any given day.

PALCA: So no detection on one day doesn't mean no infection. The tests the CDC developed requires expensive equipment. Charles Chiu is trying something different.

CHARLES CHIU: We're developing a test that is going to be fast, portable, cheap and suitable for point-of-care settings.

PALCA: Chiu is at the University of California, San Francisco. His test uses a new technology called CRISPR. It could be ready in months.

CHIU: We do need clinical samples from infected patients to be able to validate, essentially verify the accuracy of the test.

PALCA: And those are not easy to come by at the moment, so proving the test works will be tricky. Several labs are trying to make faster, cheaper diagnostic tests using a variety of new technologies. But Gene Olinger says it's best to exercise a healthy skepticism about these new approaches. Olinger is a science adviser for MRI Global, a not-for-profit research institute in Kansas City.

GENE OLINGER: There is a great divide between the excitement of a new technology and actually making it robust and repeatable and meeting regulatory standards.

PALCA: Olinger works with companies that make and market diagnostic tests. He says it's expensive to develop, validate and distribute a new test. When I spoke with him last week, he said companies were trying to decide whether this coronavirus outbreak was going to be like the outbreaks caused by MERS and SARS - in other words, would they just pop up and then disappear?

OLINGER: Or is this something that's going to be in the circulation for a long period of time? And, you know, clinicians will need this. And I think, in the last 24 to 48 hours, I've seen companies starting to realize that this is going to be something they have to face and start working with. So I think the idea that we can contain this and it would just disappear is going away.

PALCA: A reality we all may have to live with.

Joe Palca, NPR News. Transcript provided by NPR, Copyright NPR.