Clinical enzymology reference measurements

Kurzfassung

A Clinical Enzymology Reference Laboratory from the Catalonia region (Spain) has wide experience on clinical enzymology reference measurements. They are looking for in vitro diagnostic manufacturers interested to ensure a traceability of the values assigned to their calibrators and materials and thus, certify reference materials.

Details

The in vitro diagnostic manufacturers are enterprises that manufacture reagents, laboratory equipment and instrumentation. To ensure their best manufacturing, they need certifying their results. Only the clinical enzymology reference laboratories can ensure a high-level quality through their certificated and innovative trials.

A Clinical Enzymology Reference Laboratory from the Catalonia region (Spain) has wide experience on clinical enzymology reference measurements. Laboratory is accredited according to ISO 17025 and is a member of a reference laboratories network of the Joint Committee for Traceability in Laboratory Medicine (JCTLM).

They have developed an own know-how relating the field of enzyme measurement standardization (catalytic activity). Thus they are able to perform reference measurements of enzymes helpful for diagnostic and prognostic in clinical chemistry laboratories. Enzyme reference measurements performed in the laboratory are based on the primary reference measurement procedures recommended by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) at 37 °C.

The enzymes included in the scope are: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alfa-amylase (AMY), creatine kinase (CK), gamma-glutamyltransferase (GGT) and lactate dehydrogenase (LD) measured in biological samples from human and animal origin.
This know-how offered allows to the in vitro diagnostic (IVD) manufacturers, clinical laboratories and so on, working ensuring traceability of the values assigned to their calibrators and materials to certify reference materials and to reference measurement procedures included in a reference system. They are looking for IVD manufacturers who following the European Directive 98/79/CE are interested to ensure traceability of their calibrators to a reference system.

Innovative Aspects:
- LREC services permits to IVD manufacturers to meet the requirements of the European Directive 98/79/CE on in vitro diagnostic medical devices.
- Directive requires the traceability of results obtained in clinical laboratories to internationally recognized and accepted reference materials and reference measurement procedures in assuring accuracy and comparability of results.
- High expertise of the laboratory in reference measurements.
- Laboratory seeks to attain the highest standards of professionalism, efficiency and reliability at all times. Only laboratory in Spain with an accreditation as a reference laboratory in clinical chemistry and the second in Europe.