Coronavirus Testing Suspended at Boston Lab After Many False Positive Results
The Massachusetts Department of Public Health (MDPH) has suspended testing for the SARS-CoV-2 virus at Boston based laboratory on Aug. 8, 2020 after the laboratory reported almost 400 false positive tests.1
Orig3n Laboratory Currently Under State Investigation
Orig3n Laboratory, a genetics and biotechnology company was suspended after state health officials became aware of an unusually high number of positive SARS-CoV-2 tests reported by the laboratory. An investigation found that there were at least 383 inaccurate positive results that were retested and came back as negative.2 Orig3n Laboratory has approximately sixty nursing homes as their customers.3
On Aug. 27, 2020, the MDPH said it notified Orig3n Laboratory that they had been cited with “three significant certification deficiencies that put patients at immediate risk of harm.”4 MDPH found that the laboratory director failed to provide appropriate management of the required processes. The laboratory did not include a control material in the extraction phase of testing and did not adhere to requirements
like documenting sanitization of its equipment.5A MDPH spokesperson said, “The Boston lab is required to respond with a written plan of correction, and if action is not taken it can face sanctions,”6
Nursing Home Negatively Impacted By False Positive Test Results
One of the nursing homes, Pines Edge Health Center at the North Hill Retirement Community in Needham, Massachusetts, was negatively impacted by the false positive tests. Ted Owens, CEO of the retirement community said that their retirement community was notified that eighteen employees and one resident were tested positive for SARS-CoV-2.7
Since the retirement community was unaware that the tests were inaccurate, the resident was quarantined in isolation and the employees were told to stay home with paid sick leave.8
Owens said, “We notified our community of residents, family members and employees about the situation, which understandably caused significant concern. The costs to the facility were also significant.” He added, “The false positive results created tremendous fear and anxiety among employees, residents and the family members of both.”9
Laboratory Blames Human Error For Inaccuracies
Orig3n Laboratory has said that the inaccuracy in testing was caused by “human error” that resulted in the contamination of tests.10
According to Robin Smith, chief executive at laboratory, the laboratory has processed “tens of thousands” of SARS-CoV-2 tests in the last three months; however, the extent of inaccurate testing at the laboratory is not known since public health officials did not re-test every sample collected at the laboratory.11
77 False Positive Tests Among NFL Players
A similar situation occurred amongst players in the National Football League (NFL). Seventy-seven individuals in the NFL who were tested for SARS-CoV-2 received test results that were false positives. As a result, eleven teams had to make adjustments to their training camp schedules due to the fear caused by the inaccurate testing.12
BioReference Laboratories, based in New Jersey, is the laboratory that the NFL hired to conduct SARS-CoV-2 tests for all of their players. According to Jon R. Cohen, MD, the Executive Chairman of BioReference Laboratories, the false positives were a result of contamination.
Dr. Cohen said…
On August 22, BioReference Laboratories reported an elevated number of positive [SARS-CoV-2] PCR test results for NFL players and personnel at multiple clubs. The NFL immediately took necessary actions to ensure the safety of the players and personnel. Our investigation indicated that these were most likely false positive results, caused by an isolated contamination during test preparation in the New Jersey laboratory. Reagents, analyzers and staff were all ruled out as possible causes and subsequent testing has indicated that the issue has been resolved. All individuals impacted have been confirmed negative and informed.13
The NFL has a protocol whereby all positive test results are followed by two additional tests over a 24-hour period. If both of those tests are negative, the original test is classified as a false positive.14
The NFL Player’s Association said they have initiated an investigation into the testing process at the lab.15
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