AUSTIN -- The state has resumed working with a California lab that found questionable results during COVID-19 testing at Texas nursing homes, officials said.
The lab returned an unusual number of positive results among asymptomatic people in early June, but officials have not said how many. They included dozens of people at nursing homes in Scurry and Eastland counties, who when retested at local hospitals showed no signs of the virus, local officials said.
The Texas Department of State Health Services said the problem involved tubes used to send samples to the lab, NovaDX.
“There was something with how those particular tubes were interacting with their equipment,” said spokesman Chris Van Deusen, who said the issue was linked to samples tested on May 29 and 30. “We looked at their data before those days and after those days and there wasn’t anything else that seemed to suggest an issue.”
False positives are rare for this kind of test, which picks up the virus’s genetic material, two experts said. None of the other labs running state tests have had similar problems.
Generally, experts said that false positives - where a person tests positive for having the virus but actually doesn’t - are caused by mishandling samples or contamination in the lab.
“The type of viral transport would be unlikely to be the result of the false positive results, but it may be possible,” said Dr. Bobbi Pritt, a professor of laboratory medicine and pathology at the Mayo Clinic in Minnesota.
State officials said it is standard practice to tell the federal regulators about any testing anomalies. But neither California nor federal officials would say whether NovaDX is currently being investigated.
The company did not respond to requests for comment.
Speedy and accurate test results are critical in stemming the spread of the coronavirus, public health experts say. The faster a sick person is identified and isolated, the fewer people they are likely to expose.
Nursing homes, where many frail and elderly residents live in close quarters, have become hotspots for the disease. To date more than 800 residents of Texas nursing homes have died from COVID-19.
Last month, Gov. Greg Abbott ordered that all 230,000 residents and employees of Texas nursing homes be tested for COVID-19. Some facilities had already begun testing on their own.
Around the country, nursing homes have been hotspots for the disease. Residents tend to be elderly and frail, and they live in close quarters, so the virus can spread more easily. Many residents also have underlying health conditions that make them more susceptible to severe cases of COVID-19.
While false positives are not as dangerous as false negatives, residents believed to be infected are isolated away from their peers, after already being not allowed to meet with their families. Nursing homes have been closed to outside visitors since March to prevent the spread of coronavirus.
NovaDX is one of 11 labs the state is using to process samples taken during widespread COVID-19 testing at nursing homes, meat packing plants and in rural areas across Texas. The company has processed at least 14,000 samples and is paid $97 for each test, officials said.
The state’s list also includes big names such LabCorp, UT Southwestern Medical Center, and Baylor Scott and White. State officials have not said how they picked the labs.
NovaDX was formed in California in 2016 as Nova Labs LLC. The current CEO, Blake Anderson of El Paso, bought the company with his father in 2018, according to public records. It’s located in a medical complex in Templeton, near San Luis Obispo. A section of NovaDX’s website about COVID-19 says, “With our testing methods, we are teaming up with companies to help get America Back to Work.”
The state began working with NovaDX on May 20, but suspended the work on June 3 after noticing an abnormally high number of positive results from five nursing homes, said Seth Christensen, a spokesman for the Texas Division of Emergency Management.
After reviewing the company’s analysis of how the problem occurred, the state said it determined the issue was an “isolated incident” involving a specific batch of tubes and solution used to transport swabs from nursing homes to the lab.
The state resumed sending samples to NovaDX on June 12, “starting at a lower number of tests to ensure they were able to keep a close eye on their data to detect any higher than normal positive results,” Christensen said. No anomalies have been identified since, he said.
Experts said after an error is found, the lab should be able to show it can test samples and get the right results. The state should also start by sending samples to both the lab in question and another one to make sure the results match, said Joe Petrosino, chair of the Department of Molecular Virology and Microbiology at Baylor College of Medicine.
The state did not detail the steps it took to clear the lab for use again.
The state also has not said how many people were affected by the testing anomalies, though officials said they notified 104 nursing facilities with samples sent to NovaDX and offered retesting.
Snyder Oaks Care Facility in West Texas said it is one of them. State-run testing turned up 39 positives at the nursing home in Scurry County, which prompted the facility to immediately isolate the people identified as sick, said spokeswoman Taylor Pittman.
“When we received information from the Texas Health and Human Services agency about the lab anomaly, we quickly set out to retest everyone that initially tested positive,” Pittman said in a written statement. “Fortunately, all of those results returned negative.”
In Eastland County, 19 people tested positive across two nursing homes.
“Nobody had a symptom, that’s what clued us to it,” said Dr. Robert DeLuca, a family physician and the Eastland County Health Officer. “We retested everybody and they were negative.”
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