In vitro diagnostic (IVD) tests are a type of clinical test in which samples are taken from the human body for analysis. Patients often make decisions about medical care based on the results of these diagnostic tests and they are regulated by the Food and Drug Administration (FD) as medical devices. This means that manufacturers of such tests must conduct clinical trials to prove their accuracy and usefulness for diagnostic purposes before bringing them to market.
IVD material that is used for analysis consists of human samples such as blood and saliva. These are tested to determine the presence and concentration of specific substances (or analytes) such as sodium and cholesterol, for the presence of other markers (such as those that indicate genetic mutation) or evidence of an immune response to an infection. Clinicians regularly use IVD techniques to diagnose medical conditions, inform treatment decisions and sometimes even to mitigate or prevent future disease from occurring.