Introduction

Until recently, molecular genetic testing was confined to specialist laboratories with substantial expertise in this area, but such tests are now increasingly being carried out in routine clinical laboratories. The development of systems to ensure the quality of testing procedures and methods has lagged behind the extremely rapid growth in the application of DNA-based testing in medicine. Concerns over the accuracy of genetic test results are given added importance because individuals are usually only tested once in their lifetime, and the consequences of an incorrect result may be far-reaching. Public perception currently holds that genetic tests are highly accurate and represent ''state of the art'' technology. These factors combine to make total quality in molecular genetic testing a matter of primary importance, if a loss of public confidence is not to result.

A broad range of products and services benefit from the development of technical standards aimed at raising levels, of safety, reliability, interchangeability efficiency and other aspects of quality. National standards institutes work together under the International Standards Organisation (www.iso.ch) to develop International Standards and within Europe these are developed as European Norms (ENs). These standards refer to the use of appropriate Reference Materials (RMs) to validate test equipment or testing methods as an important part of any analytical testing system. Currently, no CRMs are available for molecular genetic testing. The IVD Directive of the EC (98/79/EC) requires, amongst other things, in vitro diagnostic medical device (IVD) manufacturers to assure the traceability of values assigned to their calibrators and control materials through available reference measurement procedures and/or available reference materials of a higher order (e.g., established International Standards.)

Thus, the demand for reference materials for genetic testing is driven by a combination of regulatory requirements and the desire of testing laboratories to be assured that their results are correct. This entry explores some of the issues which must be considered when designing RMs for molecular genetic testing and describes current research and development efforts in this area.

Getting Started With Dumbbells

Getting Started With Dumbbells

The use of dumbbells gives you a much more comprehensive strengthening effect because the workout engages your stabilizer muscles, in addition to the muscle you may be pin-pointing. Without all of the belts and artificial stabilizers of a machine, you also engage your core muscles, which are your body's natural stabilizers.

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