In vitro diagnostic (IVD) tests are medical devices intended to perform diagnoses from assays in a test tube, or more generally in a controlled environment outside a living organism. In vitro refers to the fact that the vast majority of these tests were originally performed in a test tube (in vitro in Latin means ‘in glass’). The modern IVD industry produces reagents and analytical instruments that are used to perform an array of in vitro tests to diagnose and monitor many different types of disease. The reagent used in an IVD test is a highly specialised chemical or biological substance that is able to react with target substances in the biological samples provided by the patient (blood, tissue or urine for example). This will give a result that can be measured or seen. The analytical instruments are the various machines and equipment that automate the process and are used to bring samples and reagents together.

IVD testing can include the measuring of concentrations of chemical and biochemical components, counting cells, measuring physical properties, examining cells and other structures under the microscope or making biological cultures. Common tests include blood tests for glucose, liver enzymes and levels of electrolytes such as calcium, sodium, and potassium.

Accessory products such as the software programs used to run the instrumentation, control solutions to check system performance are also produced by the IVD industry.

Together the reagents, instruments and accessories are referred to collectively as an in vitro diagnostic system.

Please click on the following link to learn more about the uses of IVDs.