Multiple Studies Raise Questions About Reliability of Clinical Laboratory COVID-19 Diagnostic Tests

In the absence of a “gold standard,” researchers are finding a high frequency of false negatives among SARS-CoV-2 RT-PCR tests Serology tests designed to detect antibodies to the SARS-CoV-2 coronavirus that causes the COVID-19 illness have been dogged by well-publicized questions about accuracy. However, researchers also are raising concerns about the accuracy of molecular diagnostics which claim to detect the actual presence of the coronavirus itself. “Diagnostic tests, typically involving a...

In New Hampshire, Cooperation Was Key to Handling Clinical Laboratory Testing Challenges Posed by the COVID-19 Outbreak

Facing a backlog, the state’s public health laboratory turned to the medical laboratory at Dartmouth Hitchcock Medical Center Much of the attention surrounding the COVID-19 outbreak—the illness caused by the SARS-CoV-2 coronavirus—has focused on large urban areas such as New York City and Los Angeles. However, the virus is impacting many rural areas as well. This is true in New Hampshire, where the diagnostic response required close cooperation between the state’s public health laboratory and...

Diagnostic Errors Get the Attention of the Institute of Medicine, Reinforcing Efforts by Nation’s Clinical Pathology Laboratory Scientists to Improve Patient Safety

Along with its assessment of the rate of errors in diagnosis, the IOM has a plan to improve, but will doctors accept the IOM’s advice, or continue business as usual? Diagnostic errors in the American healthcare system is a problem that is now on the radar screen of policymakers at the Institute of Medicine (IOM). Pathologists and clinical laboratory professionals will welcome this development, because recommendations from the IOM carry weight with Congress. Thus, should the IOM develop...
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