High temperatures in Montgomery County didn’t adversely affect saliva specimens collected for COVID-19 testing by the Rockville-based AdvaGenix, according to a study completed by the company.
“Our preanalytical temperature stability study demonstrates that no saliva sample was compromised by excessive heat,” said Dr. William G. Kearns — AdvaGenix’s CEO, chief scientific officer and director — in a statement.
The in-house assessment was conducted after the county last week terminated its contract with the lab, which provided and processed tests for free sites, following concerns over AdvaGenix’s procedures.
All free COVID-19 testing was halted in the county so the company’s testing and lab processes could be reviewed. In the meantime, Montgomery County is directing its residents to other locations that are offering tests.
About 8% of the more than 251,000 COVID-19 exams administered in the county over the last two months came from AdvaGenix, according to a statement from the county government earlier this month.
In its study, the lab determined that previously tested positive and negative saliva specimens were stable in simulated outdoor and shipping conditions.
A review of Montgomery County temperature data between June 1 and Aug. 16 found that the temperature never rose above a level that would affect the stability of the specimens, according to a document from Kearns.
On Saturday, AdvaGenix submitted its findings to the state and the Centers for Medicare & Medicaid Services’ Clinical Laboratory Improvement Amendments.
“We look forward to prompt review by CMS and the State,” Kearns wrote, “so that we can resume the important work of testing during this public health crisis.”
