Thousands of coronavirus test kits Honolulu plans to order from a Texas-based company haven’t been authorized by the federal agency that oversees test kits.
State health officials also say the test kits would need state Department of Health certification, which they haven’t received.
But city officials, who plan to spend about $1 million to purchase 10,000 test kits from EverlyWell, say they are still confident that those tests will be reliable enough to expand testing capacity on Oahu.
Those test kits and others like it in the state did not receive an Emergency Use Authorization from the U.S. Food and Drug Administration.
The EUA was set up by Congress as a way to fast-track development of test kits in the U.S and get what is basically a thumbs up from the FDA without going through the lengthy processes typically required for a formal approval.
Companies like EverlyWell, a company that links consumers to labs to get test results, would not likely receive an EUA from the federal government, which has reserved such authorizations for individual laboratories, Christina Song, a company spokeswoman, said in an interview.
Correction: An earlier version of this story misspelled Christina Song’s name.
EverlyWell’s partner labs, which the company declined to list, either do have an EUA or are in the process of applying for one, Song said. Those labs already perform similar tests elsewhere on the mainland.
The company relies on an undisclosed third party to actually put the test kits together.
The FDA criticized companies like EverlyWell in March for planning to roll out at-home test kits that weren’t vetted by the FDA. One of the concerns was that folks might not properly use the kit at home.
Those kits have been repurposed for use by hospitals and government agencies, like the City and County of Honolulu.
In addition to the $1 million being paid to EverlyWell for the kits, the city is spending $1 million more to cover the cost of testing at seven community health centers on Oahu. So, folks won’t be taking those test kits home to swab themselves.
EverlyWell has been working with the United Parcel Service to expedite deliveries to partner laboratories in the mainland to get test results in 48 hours. The company began distributing to Los Angeles in late March.
Guy Kaulukukui, the city’s Department of Enterprise Services director, said Wednesday that he vetted the EverlyWell tests with the Los Angeles mayor’s office.
He said the office found no concerns with the tests’ reliability or the 48-hour turnaround time for results. The tests have a false negative rate of about 3%, Song said.
Gov. David Ige’s COVID-19 emergency declaration on March 4, which suspended the public procurement code, allowed the city to purchase the test kits without using its usual process for a noncompetitive purchase, Kaulukukui said.
While researching other test kits, Kaulukukui found that the kits used by Diagnostic Laboratory Services also do not have an EUA.
Clarification: Kaulukukui now says that he was referencing a document from mid-March that said that those tests were under review for EUAs. Since then, the laboratories DLS works with all received EUAs.
State Department of Health Director Bruce Anderson told a panel of senators Wednesday afternoon that tests conducted in the state must be certified by both the FDA and the DOH.
State Epidemiologist Sarah Park shared similar concerns in a phone call last week with the city.
But the FDA does not certify or approve COVID-19 test kits, EverlyWell’s Song said.
Kaulukukui said that he, Roy Amemiya, Caldwell’s managing director, and Robert Hirokawa, CEO of the Hawaii Primary Care Association, briefed Park and the DOH on plans to purchase the kits in a call last week.
When asked by senators if he supports the city’s testing program, Anderson said he wasn’t aware of it until Caldwell made the announcement Tuesday afternoon.
“I think he’s well meaning in this regard. He felt there was a need for more testing at community health centers,” Anderson said. “What he probably didn’t know at the time was we have capacity at our local labs to do this testing.”
Anderson also said he is often contacted by companies offering their test kits.
“There’s lots of fly-by-night companies out there that want to make a quick buck,” he told the Senate special COVID-19 committee.
An EUA could be granted for a company’s test kits within a day, according to the FDA. The agency is aware of 110 labs that have started using their own tests.
As of Wednesday, it had approved an EUA for 43 labs.
The FDA declined to comment on the EverlyWell tests and did not answer Civil Beat’s questions about whether it has worked with EverlyWell and other companies on developing testing kits. The agency noted that any COVID-19 tests conducted at-home need an EUA.
“The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space,” the agency said in a written statement Wednesday.
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