Inconclusive COVID-19 test results and delays in reporting results continue to plague the state of California’s brand new clinical laboratory, located in Valencia. That’s according to reports by several news outlets in the Golden State.
On Nov. 20, CBS13 reported that the “state’s new billion-dollar PerkinElmer lab is returning a high number of inconclusive test results which may be skewing the testing turnaround times provided by the state.” CBS13 also said that, as of late November, the Valencia lab had returned only 35% of results in two days or less, which is the turnaround-time target for the lab.
Disruptive to Other Labs?
There are legitimate questions as to why the state government would decide to build its own clinical laboratory to perform high volumes of COVID-19 tests, and thus be a direct competitor to existing clinical labs in California. The Valencia lab immediately puts the state in competition with existing labs for test kits, supplies, and the limited number of qualified genetic PhDs and clinical laboratory scientists. This potential of the state’s lab to disrupt the operation of other labs has not yet been addressed by journalists in California. (See TDR, Nov. 16, 2020.)
The State of California signed a no-bid contract with PerkinElmer to build and operate the laboratory. The contract will be worth as much as $1.7 billion to PerkinElmer. The initial cost for the state to get the lab in operation was $25 million.
The clinical lab opened around Oct. 30. By the end of the first month, California reported that the lab had processed 100,000 COVID-19 tests, while disclosing that one out of every 29 were inconclusive (a rate of 3.5%).
Issues with Validation Step
California’s health secretary, Mark Ghaly, MD, told CBS13 that one source of the inconclusive results had been identified. He said, “One of the validation steps that confirms the necessary chemical reaction to run the test didn’t occur for some of those inconclusive tests. We’ve identified some of the issues with why they didn’t occur and have since corrected them.”
CBS13 asked Sacramento County for statistics on COVID-19 tests within its boundaries. It said, “While the state did not provide us [CBS13] with the number of inconclusive tests coming from all other labs for a comparison, Sacramento County did. They received 95 times more inconclusive [COVID-19 test] results from the PerkinElmer lab than all other labs combined during the first two weeks of November.”
The State of California plans for the clinical lab in Valencia to perform 150,000 COVID-19 tests per day. PerkinElmer’s agreement with the state government calls for the lab to be fully operational and achieve a 48-hour turnaround on those test results by March.