In vitro diagnostics

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 means in glass in Latin.

Definition

A 'in vitro diagnostic medical device' is, according to the directive 98/79/EC:

‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

— concerning a physiological or pathological state,or — concerning a congenital abnormality, or — to determine the safety and compatibility withpotential recipients, or — to monitor therapeutic measures.

Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;

—Official Journal of the European Communities L331/1 de 7 december 1998.

Usage

Common tests include blood tests for glucose, liver enzymes, levels of electrolytes such as calcium, sodium, and potassium, and tests for drugs.

Purposes of testing include protecting the blood supply, monitoring the levels of drugs given and providing information to assist in the diagnosis and treatment of disease. These tests are generally run in hospital pathology laboratories and can in specific instances also be carried out in doctors’ surgeries, in high street pharmacies or by patients themselves.

References

[1]www.salda.org.za==External links==

• European Diagnostic Manufacturers Association (EDMA)

See also

Immunoassay