NEW YORK, July 2 (Reuters) - COVID-19 testing supplies distributed by the federal government have failed quality checks and are arriving late, Washington state's top health official said in a letter to a senior administration official, warning of problems as cases spike.
Several state lab directors and the director of the Association of Public Health Laboratories also told Reuters that supplies were short.
Widespread testing is one of the core requirements necessary for controlling the spread of the novel coronavirus, and delays in tests raise the likelihood of transmission.
"The nascent federal supply effort for COVID-19 testing has been beset by logistical problems that impede our pandemic response and undermine our shared goals," Washington state Secretary of Health John Wiesman said in his June 30 letter to U.S. Assistant Secretary for Health Admiral Brett Giroir.
The supply chain problem "threatens to limit our overall testing capacity at a critical time in the pandemic response," he said. (For a copy of the letter, see: tmsnrt.rs/38uOkyg)
Two months ago, seeking to address problems in the national supply chain, the federal government started sending states weekly shipments of swabs and chemicals used to gather and preserve specimens for testing. Wiesman thanked Giroir for the help.
But he said that system is beset with problems, including swabs that have had to be re-sterilized and shipments delayed without temperature control.
Addressing the state's concerns about poorly packaged swabs and chemicals specifically, the Department of Health and Human Services said that beginning in July it will provide states with individually wrapped sterile swabs.
"We are in constant contact with states to overcome any issues with testing supplies and reagents and are working with states to ensure they have testing materials," said agency spokeswoman Mia Heck in a statement.
Corporate test makers also are not meeting demand.
Scott Shone, the director of North Carolina's public health laboratory, said he had been told by the federal government and clinical labs in his state that Roche would not be able to ramp up production of reagents, chemicals used in tests, until later this year, and that Danaher's Cepheid would not be able to ramp up supplies until early 2021.
"The supply chain is just not there to support the growing demand for testing," he said.
The concerns about strains in the testing supply chain have emerged in the last two weeks as COVID-19 cases have surged in Texas, Florida, Arizona and California.
Roche, Cepheid, and every other supplier reached by Reuters acknowledged that demand for tests exceeds supply. All are working to boost production, but none said when they expect to be able to meet demand.
Joe Saad, chairman of pathology with the Methodist Health System in Dallas, said Texas, a hot spot, does not appear to be receiving priority supplies. "How they're allocated is a complete mystery to us," he said.
Methodist relies more heavily on outside labs when it is short on supply, and tests it can do in six hours in house are taking four to six days from the outside lab, he said.
Quest Diagnostics, a national independent lab, said on Monday that for all but its highest priority patients, results were taking three to five days because of "surging demand." Customers had previously told Reuters that their turnaround was usually two to three days.
Scott Becker, chief executive of the Association of Public Health Laboratories, says he has heard from a handful of state health laboratories in the last two weeks that they are short on reagents or other supplies they need to do COVID testing.
He is worried that testing may have to be limited to people showing symptoms, as it was early in the pandemic. "I'm concerned that we are going to be forced to go a little bit backwards." (Reporting by Ned Parker in New York and Allison Martell in Toronto; Editing by Peter Henderson and Daniel Wallis)