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Massachusetts suspends Boston-based coronavirus testing lab Orig3n after nearly 400 false positives

Boston Herald

The state has suspended Boston-based COVID-19 testing lab Orig3n Laboratory after it produced nearly 400 false positive results. Public health officials became aware in early August of an "unusually high positivity rate" among the lab's test results and requested that Orig3n stop testing for the virus as of Aug. 8. Specimens were sent to an independent lab to be retested as part of a state Department of Public Health investigation, and the results showed at least 383 false positives. On Aug. 27, the state Department of Public Health notified Orig3n of "three significant certification deficiencies that put patients at immediate risk of harm," according to a DPH spokeswoman. They included the failure of the lab's director to provide overall management, issues with the extraction phase of testing, and a failure to meet analytic requirements such as documenting the daily sanitizing of equipment used for coronavirus testing. A statement of deficiency was issued on Sept. 4. The lab must now respond with a written plan of correction by Sept. 14, "and if action is not taken it can face sanctions," DPH said.