Advances in research have led to the development of medical tests that can detect thousands of conditions. Tests that would take days, if not weeks, to get results just a few decades ago can now give health care providers answers in mere hours or even minutes. From glucose testing to HIV tests, doctors and hospitals rely heavily on these tests in order to diagnose patients. Some tests, like pregnancy indicators, can be done in the doctor’s office. Others are sent to labs which have their own rapid tests that can provide information quickly. Yet for several years now these tests, and the laboratories and technicians that administer them, have come under greater scrutiny due to errors that have led to misdiagnosis and even death.
Diagnostic tests are regulated differently depending on how they are manufactured and distributed. Currently, the FDA has to review and approve tests that are manufactured and sold commercially to multiple labs. It is the manufacturers’ responsibility to inform the government if there has been a death or serious injury as a result of the tests, as well as if there is a recall. However, tests that are manufactured by and for use in a single lab do not fall under FDA review. Often these “waived tests” are based off commercially approved ones, though their accuracy may vary.