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ALKALINE PHOSPHATASE

Objective



Alkaline phosphatase (AP) is an enzyme found in particular in the cells which are responsible for the bone formation (osteoblasts). This enzyme is involved in the process of calcification of the bone. The catalytic activity of the enzyme is measured in serum primarily for the diagnosis of bone disease. It is an adjunct for the detection of bone cancer.

The project involves the purification of alkaline phosphatase extracted from porcine kidney, its stabilization in an albumin matrix and the production of a batch of samples for certification. The catalytic activity concentration of AP in the partly purified preparation will be certified according to the method of the International Federation of Clinical Chemistry (IFCC).

RESULTS

The project was completed in 1988. A stable preparation of partly purified alkaline phosphatase was produced. The material is in lyophilized form. A strict procedure for reconstitution of the lyophilized enzyme preparation was specified to avoid time -and temperature -dependent increase of activity of the reconstituted AP preparation. The catalytic concentration activity of the reconstituted material was measured by 14 laboratories according to the IFCC method. The certified value and uncertainty were established as:
CRM 371 (254 +/- 6) U/l.
Details on the preparation of the partly purified enzyme and on the results of the certification campaign are presented in the report EUR 11774 (1988).

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

Boehringer Mannheim GmbH
Address

Penzberg
Germany

Participants (13)

Centre du Médicament
France
Address

Nancy
Fondazione Centro San Romanello del Monte Tabor
Italy
Address

201 Milano
HANNOVER MEDICAL SCHOOL
Germany
Address
Carl-neuberg-strasse 1
30625 Hannover
Hospices Civils de Lyon
France
Address

Lyon
Medizinische Universität Lübeck
Germany
Address
Ratzeburger Allee 160
23562 Lübeck
Metaxas Memorial Cancer Hospital
Greece
Address

Piraeus
National Institute for Biological Standards and Control (NIBSC)
United Kingdom
Address
Blanche Lane South Mimms
EN6 3QG Potters Bar
Odense University Hospital
Denmark
Royal Free Hospital
United Kingdom
Address

London
Royal Postgraduate Medical School
United Kingdom
Address
150,Ducane Road
W12 ONN London
St Radboud Ziekenhuis
Netherlands
Address

Nijmegen
UNIVERSIDAD AUTONOMA DE BARCELONA
Spain
Address
Campus De La Universidad Autonoma De Barcelona
UNIVERSITE DE LIEGE
Belgium
Address
Place Du 20 Aout, 7