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loginDiagnostic tests are an important part of medical care.1For purposes of this paper, we define “diagnostic tests” as those tests performed on samples taken on and from the body, and used in a broad range of applications. These tests are also referred to as “in vitro diagnostics” or “IVDs.” Test results can be used to aid the patient, physician, and caregiver in reaching decisions. Depending on the test and the methods used, testing can be performed at a centralized laboratory, the hospital bedside, the physician’s office, the clinic, the workplace, and even the home. Diagnostic tests are often the least expensive component of the health care pathway, yet they influence more than 70 percent of health care decisions.