The Department of Public Health has suspended the COVID-19 test on Origin 3N in a Boston laboratory, after a state investigation revealed that at least 383 samples found in the laboratory positive for the virus were actually negative. Were.
Since April, Origin3N has worked with about 60 nursing homes in Massachusetts for screening of coronaviruses. But a state investigation launched in August found that system requirements, including poor management, lack of proper test materials, and properly documenting “putting the detergent at immediate risk of harm”, according to a statement by a DPH spokesperson Failure to complete.
“In early August, the Massachusetts Department of Public Health came to know of an unusually high positivity rate tested by Origin 3, a COVID-19 testing laboratory,” the statement said. “Boston Lab is required to respond with a written plan of reform, and it may face sanctions if action is not taken.”
Orig3n stopped its Massachusetts COVID-19 testing on August 8, shortly after DPH began its investigation. The state gave an official suspension on Friday, September 4, and gave the company until September 14 to show that all deficiencies in its process had been addressed.
Massachusetts officials became concerned about Origin 3N’s practices in early August, when the high-percentage average of tests processed in that lab was positive. When DPH sent some of those positive samples to other laboratories for verification, 383 tested negative, meaning that the original results were incorrect.
The true scale of Orig3n’s test failures is unknown – as is its impact on Massachusetts’ overall COVID-19 tracking efforts. State officials did not process every sample Orig3n, meaning that the total number of false positives could be higher. Officials also did not specify how many tests the lab has conducted in Massachusetts, although a statement released Tuesday by chief executive Robin Smith claimed that Origin 3N had provided COVID- for customers around the country in the last 90 days. Has processed “thousands upon thousands” of 19 tests.
“[A false positive] That would certainly cause anxiety and stress for the person and friends and family members, said Dr. David Hammer, an infectious disease specialist at Boston University School of Public Health and physician at Boston Medical Center. Incorrect positives can also waste valuable hospital and public health resources, he said, with missteps asking patients to potentially quarantine, treat and retire, and track and self-isolate their contacts.
Hammer explained, “It is really hard to put a number on how common mistakes are for molecular COVID-19 tests, but they said they are rare.” “There were chances of some lab deficiencies [at Orig3n], ”Said Hammer.
state The investigation revealed inherent problems that could lead to inaccurate results on Origin 3N. Lab leadership failed to provide adequate management and oversight. A key control material used to double-check the test process was missing. Accurate reports and records documenting certification of laboratory and testing equipment were also inadequate.
“We understand the critical importance of speed and precision in COVID-19 testing, and we are committed to providing accurate, timely results for our customers,” Smith said in a statement provided to The Boston Globe. He stated that new test results were reported to customers receiving false positives and the lab immediately created a protocol to prevent further mistakes. “We are currently working with the MA position to finalize steps that will enable us to resume testing in our Boston lab,” Smith said.
This is not the first time the testing practices and integrity of Orig3n have been called into question.
Founded in 2014, Orig3n sells DNA testing kits that are pure to provide personal insight into the nutritional, fitness and beauty needs of customers. The company also produces customized multivitamins that it says are based on the results of DNA testing. But in September last year, Bloomberg Businessweek reported that 17 former employees accused the lab of selling the wrong test and tampering with the results – accusations the company denied and called it “gross flawed”.
According to company documents, Origin 3N performed more than 300,000 genomic tests in 2019. It is jointly certified by the Clinical Laboratory Improvement Amendment of Medicare & Medicaid Services of America. In April, it received an Emergency Use Authority from the Food and Drug Administration to distribute and process molecular COVID-19 tests. Orig3n tests, like most clinical COVID-19 tests, work by detecting the signs of SARS-CoV-2, which causes the disease.
In addition to working with Massachusetts nursing homes, the company markets its testing services to colleges and universities, schools and employers. It has partnered with the North Carolina Department of Health and Human Services, one of several laboratories supporting the state’s free testing program for high-risk communities. Since all Origin 3N tests are processed at its Boston lab, the DPH suspension will stop its COVID-19 testing nationwide.