Alkaline phosphatase (ALP) raw material

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<b><i>Please note that this is not a call for tenders but a publication announcing the Contracting authority’s <a href="https://ec.europa.eu/docsroom/documents/40287" target="_blank">intention to publish a future negotiated low or middle valueprocedure. </a> </i></b><br></br>A new CRM for ALP will be produced and the processing will be done by an external company specialized in the production of control material for human enzyme measurements. This human alkaline phosphatase (ALP) material will be used to develop a reference material certified for its catalytic activity concentration. The catalytic activity of ALP in serum is frequently measured in medical laboratories for the detection and diagnosis of liver diseases (such as cirrhosis, hepatitis and cancer) and bone disorders. In order to contribute to a clinical decision, the obtained results should be accurate and equivalent, independent of reagents kits, instruments or the location and time of testing. Standardisation of enzyme measurements can be achieved by using reference systems, in which certified reference materials together with the reference measurement procedures developed by the International Federation of Clinical chemistry (IFCC) are the key components.