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Laboratory developed tests (LDTs) are non-commercial tests that labs create and use internally. These tests play a vital role in getting patients accurate diagnoses and effective care, and at no time has their importance been more evident than during the current pandemic. When the coronavirus first reached the U.S., the only widely available test for the virus was flawed. As a result, healthcare providers had to rely instead on LDTs created by commercial laboratories and academic medical centers to diagnose and triage patients.
As the pandemic goes on, LDTs continue to play a critical role in efforts to combat the coronavirus. In this video, AACC laboratory experts discuss this in detail, as well as the regulatory barriers that nearly prevented laboratories from developing and introducing these tests for the coronavirus.