What is an IVD?
‘In vitro’ is Latin for ‘in glass’, indicating that IVDs are tests performed on a sample outside their normal biological context. This means that in vitro diagnostics test a sample of tissue or bodily fluid in an effort to diagnose a disease or condition. Classically, these tests are carried out in a test tube or on a laboratory dish, hence the name ‘in vitro’.
This is in contrast to ‘in vivo’ diagnostics, which are carried out in or on the full body and include techniques such as imaging. In the past IVDs were mainly involved in the branch of medicine that deals with the lab examination of samples of body tissue for diagnostic purposes. Today, however, in vitro diagnostic tests do not necessarily have to be carried out in the lab. IVDs can now be performed at the point-of-care (POC) or by individuals themselves at home, e.g. self-monitoring of blood glucose for management of diabetes.