PHOENIX (3TV/CBS 5) -- As the largest lab processing COVID-19 test kits is busting through backlog, there are new questions about whether Arizonans can trust the results. State Representative Kelli Butler has now sent two letters to the Arizona Department of Health Services asking the agency to attest labs are properly storing the test kits until they are processed.
“This data, it’s so important that it be accurate, and that we have the confidence that we can rely on it,” says Butler.
Butler is concerned test samples may degrade over time and produce false negatives. She’s calling for transparency from state leaders as they push to open schools and businesses.
“These are life and death decisions, and we have to be confident that our department of health is giving us the right information and that they're willing to share with us the information they have,” says Butler.
Organizers had hoped to test 60,000 Arizonans but only around 13,000 got tested.
Butler says she has yet to receive a response from ADHS. Arizona’s Family also requested information about the storage of test samples and did not receive a response.
Without answers from state health officials, Arizona’s Family turned to University of Arizona Professor of Immunology Dr. David Harris. Harris and his team have produced more than 25,000 COVID-19 test kits for rural Arizona and tribal communities.
Harris says Arizonans can trust COVID-19 test results reported by labs because they are certified and audited by state health officials. Harris also says there is a built-in process to determine a given sample is good and everything used for testing is working.
“There's an internal control to make sure that the test is actually working whether it’s a one-day old kit or a ten-day old kit,” says Harris.
Sonora Quest reported a backlog of more than 17,000 test kits Friday, and the lab is expected to complete the tests this weekend. The lab says it’s using eight special freezers to store test kits at ultra-cold temperatures.
There’s no end in sight to the coronavirus pandemic, according to health experts.
During a press conference Thursday, the director of the Arizona Department of Health Services expressed confidence in the lab’s ability to store samples and produce accurate results.
“[The results] will be accurate. It depends on how long you’re storing it and where you’re storing it,” said Dr. Christ. “Sonora Quest has been storing them appropriately in a deep freeze at about negative 70 and they have enough freezer space.”
Because labs are trying to detect genetic material, Dr. Harris says, freezing is not always necessary.
“That material is fairly resistant to harsh environmental conditions,” says Harris.
FDA guidelines dictating the handling of COVID-19 test kits say “inadequate or inappropriate specimen collection, storage, and transport are likely to yield false test results.”
The FDA instructions say specimens can be refrigerated for up to three days after they’re collected, but if the tests must be stored longer than that, they must be frozen at -70 degrees Celsius.
Sonora Quest says its freezers are holding test kits at -70 degrees Celsius. So far, ADHS and Sonora Quest have not answered questions about how many kits each freezer can hold.
The ADHS also released this following statement:
Commercial laboratories have been a critical partner during the COVID-19 response. ADHS has confidence in diagnostic lab results reported by our commercial laboratory partners and has been providing support to labs, such as SonoraQuest, to decrease turn-around times.