EDMA

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EDMA Annual Report 2009

 

EDMA General Assembly - 27/28 October 2010 - Brussels

 

EDMA/IFCC Workshop on Reimbursement of Innovative Technologies - 26 November 2010 - Brussels

 

 

 

 

 

IVD Industry in Europe
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About In Vitro Diagnostics

What are IVDs?

The name in vitro diagnostics (IVDs) refers to the fact that most of these tests were originally performed in a test tube (in Latin, in vitro means "in glass"). The IVD industry produces analytical instruments and the reagents that are used to perform in vitro tests. These reagents are solutions of highly specific biological or chemical substances that are able to react with target substances in the samples (blood, tissue or urine) to give a product 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 may include measuring the concentrations of chemical and biochemical components, counting cells, measuring physical properties, examining cells and other structures under the microscope or making biological cultures. Accessory products such as the software programs used to run the instrumentation, control solutions to check the performance of the systems, are also produced by the IVD industry. Together the reagents, the instruments, and the accessories are referred to as "in vitro diagnostic systems".

The majority of IVD tests is performed on highly automated equipment in hospital laboratories, but an increasing number of tests are also available for point of care testing (POCT) or patient self-testing (e.g. pregnancy tests). Laboratory tests can be developed in formats that are suitable for public use and give rapid results, even tests requiring blood sampling (e.g. blood glucose tests for diabetics) are being developed into user-friendly products. This trend has become of increasing importance as people are now more and more concerned about their health. However, many tests (e.g. for HIV) have not been accepted by health authorities and healthcare professionals for self-testing in order to avoid that the individual concerned would have to deal with the test result without medical counselling.

Apart from the obvious patient benefits, IVDs also provide for a number of economic benefits. Allowing earlier and more appropriate treatments shortens the length of hospital stays, rules out expensive treatments and reduces costs for the treatment of complications. Money spent on IVDs is a clear investment in health. Please visit the following links for disease-related information on IVD tests:

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