Rapid testing could transform how health care professionals respond to the coronavirus pandemic.
Silicon Valley-based company Cepheid has produced a test that promises to return results in about 45 minutes — significantly faster than other available options. On March 21, it became one of the first rapid tests given emergency authorization by the Food and Drug Administration.
But many California labs can’t get their hands on Cepheid’s tests.
Their technology uses cartridges that are compatible with a popular piece of testing equipment in California, called the GeneXpert, which the company also produces. Many labs and hospitals already have a GeneXpert and use it to test for diseases including tuberculosis.
In Madera County, its lab currently has no way to test for coronavirus, but it does have a GeneXpert. The county public health department put in an order for cartridges last week, according to department director Sara Bosse.
“We were notified that we were going to get a week’s worth of cartridges,” she said. “And then we got an email that said they were changing their delivery algorithm.”
She says a Cepheid sales representative said the tests would not be available to the county until the end of April — at the earliest.
Bosse says Madera, which had 21 cases and one death as of Tuesday, is still focusing on containing the outbreak. She adds that rapid testing would substantially improve their ability to identify positive cases and test potential contacts.
Madera currently sends its tests to outside labs, which takes up to three days for results from a public lab and up to eight from a commercial one.
In Monterey County, Cepheid also told director of public health Donna Ferguson the tests wouldn’t be available for at least four weeks.
She participates in weekly conference calls with public health officials from around the state and says other laboratories in California are having trouble accessing Cepheid’s rapid testing, as well.
“The state laboratory is not receiving any test kits from Cepheid, and the state laboratory is the backup laboratory for the 29 local laboratories,” she said. “They’re actually affecting testing throughout the state.”
The California Department of Public Health declined an interview request. In an email, a spokesperson said the department is working to get rapid tests to labs and hospitals and “may have more information on this … in the coming week.”
Ferguson and Bosse said they have been in contact with nearby hospitals in recent days that have also been unable to purchase the tests.
But it’s unclear how many hospitals are impacted. Jan Emerson-Shea with the California Hospital Association says the organization does not track which health systems have obtained rapid testing kits.
Darwa Peterson, a spokesperson for Cepheid, said the company has provided test cartridges to hospitals and labs in California, but did not respond to questions about which ones, and how many tests have been delivered. Cepheid also declined an interview request.
“All of our resources continue to be focused on ramping production and shipping tests,” she said in an email.
Rapid testing could be extremely valuable for hospitals and public health labs to identify and isolate people who test positive, according to Dr. Rick Greenwood, an adjunct professor of epidemiology at UCLA.
“You can jump on them very quickly, so they don’t continue to have contacts,” he said.
Cepheid is one of several companies that have gotten approval for rapid testing in recent weeks. Abbott Laboratories has produced a test that will return results in as little as five minutes. The question of where to distribute those tests in the U.S. has also stirred debate.
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