CHARLOTTE, N.C. — Before North Carolina even confirmed its first COVID-19 case, internal emails show the state considered creating its own test, but decided against it.
"Development, validation, and implementation of an LDT (laboratory developed test) will be expensive, resource intensive (human and otherwise), and take weeks (if not longer) to complete..." North Carolina State Laboratory of Public Health Director Scott Shone wrote in an email On February 25. "...If every state has their own (even subtly different) version of an LDT, assay performance metrics could vary, which could impact our detection and surveillance statistic comparisons."
In follow-up emails, the assistant health secretary, state epidemiologist, and state health director all agreed with his reasoning. Shone also said Kentucky indicated an interest in collaborating "if we want to jointly pursue an LDT (could save some time and costs)."
Today, testing sites now cover North Carolina as the state has doubled its testing capabilities to roughly 6,000 people a day. However, during the first two weeks of March, Mecklenburg County Health Director Gibbie Harris expressed frustration in the lack of testing kits.
"Everybody is a bit limited at this point," she said at the time. "We were sent just three tests."
In an email to WCNC Charlotte, the North Carolina Department of Health and Human Services defended its decision to not create its own test.
"Limited testing capacity experienced by every state was related to several significant supply chain issues. These challenges have been well documented in a variety of press outlets across the country and included availability of collection devices (swabs and viral media), testing supplies (extraction and test reagents), and scientific instruments," NCDHHS Communications Manager Kelly Haight Connor said. "A laboratory developed test (LDT) would not have resolved those widespread challenges as it would have required the same resources and also resulted in a significant regulatory burden for the State to obtain an EUA (Emergency Use Authorization) from FDA."
Charter Oak Development CEO Brett Portaro is the state and federal distributor for BGI, a major testing company. He knows the challenges the industry has faced in recent months and thinks testing is better left to private companies that specialize in it.
"I think asking the state to create a PCR test is pretty unfair to the state," he said. "I'm not sure that they could've necessarily created their own tests, but what they could have done is prepare themselves on the lab piece and the lab piece is the log jam right now,
On March 3, the same day North Carolina announced its first COVID-19 case, emails show the state lab could run tests for just 150 to 200 patients.
A talking point that day shows the state leaned heavily on the federal government early on:
"We have an initial supply (of testing kits)," the senior director of external affairs wrote. "We are encouraging the federal government to expand the number of manufacturers able to produce these kits. Fortunately, we are close to Atlanta and can rely on the CDC for tests if needed."
In an interview with WCNC Charlotte earlier this month, Gov. Roy Cooper said North Carolina could no longer rely on the federal government.
"I realized a month-and-a-half or so we weren’t going to be able to be dependent on the federal government..." he told us. "...They’ve helped, we’ve appreciated it, but we know it’s going to be up to us as a state."
MORE ON WCNC CHARLOTTE: