State raises concern about city’s ambitious testing program, saying kits aren’t FDA-approved

Hundreds showed up for COVID-19 tests at Kakaako
Hundreds showed up for COVID-19 tests at Kakaako(Hawaii News Now)
Published: Apr. 23, 2020 at 12:37 PM HST|Updated: Apr. 23, 2020 at 12:39 PM HST
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HONOLULU, Hawaii (HawaiiNewsNow) - There’s growing criticism from state officials a day after Mayor Kirk Caldwell announced enhanced testing efforts.

Caldwell said the city is spending $2 million to ramp up COVID-19 testing on Oahu.

But state Health Director Dr. Bruce Anderson says the city launched their initiative without coordination with the state, and he’s concerned with the quality of the test kits.

The city says the kits are proven accurate and already being used around the country.

Kits are being purchased from Texas-based health company EverlyWell.

State officials say, however, the kits are not FDA approved. The kits and the labs are FDA authorized under the emergency use authorization.

“There are many tests available that have received its emergency use authorization and there are additional tests that are being administered today in our community that have not had their emergency use authorization but have been developed along guidelines published by the FDA in order to get more testing available in our communities,” said Guy Kaulukukui, director of the city Department of Enterprise Services.

The city’s testing efforts will utilize community health centers that will conduct the tests. UPS ships the samples overnight to the labs on the mainland and results are promised within 48 hours.

Company officials say their kits have a less than 3% false negative rate and that the city of Los Angeles is also participating in their program.

State Health Director Bruce Anderson says he only heard of Caldwell’s plans to expand testing Tuesday.

Some state lawmakers are baffled over the miscommunication between agencies.

“I think he was well meaning in this regard. I think he felt there was a need for testing capability, particularly in the community health centers. What he probably didn’t know at the time — cause I just got the information — is that we have the capacity through the local labs to do the testing,” Anderson said.

State Sen. Donna Mercado Kim responded at a COVID-19 committee hearing, “And that’s the point that I am trying to make is that the right hand doesn’t know what the left hand is doing. The city spent about $2 million on 10,000 kits.”

But Wednesday night, city officials chimed back, saying they did share their plans at a meeting last week with Health Department officials that Anderson did not attend.

“We spoke to Dr. Park seven days before the announcement,” Kaulukukui said. “I’m firm we had this conversation April 14. I don’t know how that right hand not taking to the left hand — that sounds like a handshake — not that we agreed, but shared all the points of our intention.”

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