Laboratory medicine and in vitro diagnostics

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Details : C18 RM32 - Creatine kinase isoenzyme MM (CK-MM) in buffer

Type (acronym)	rm2
Type	reference material
Unique Nomination Number	C18 RM32
Analyte Name	Creatine kinase isoenzyme MM (CK-MM)
IUPAC IFCC Number	EC 2.7.3.2.
List I, II or III	List I
Basis for Traceability Claim	Procedurally-defined: IFCC primary reference measurement procedure for the measurement of catalytic activity concentration of creatine kinase at 37 °C. Schumann et al., Clin. Chem. Lab. Med., 2002, 40, 635-642
Applicable Matrices	recombinant form of human CK-MM in a buffer (pH 7.5) containing among others bovine serum albumin and polysaccharides
Identifier Number	ERM-AD455k/IFCC
Name	Creatine kinase isoenzyme MM (CK-MM) in buffer
Certifying Organization	JRC
Quantity	Catalytic activity concentration
Level of Confidence (%)	95 %
Reference to Commutability Study Publication	Intended use statement: The main purpose of the material is to control the performance of the IFCC primary reference measurement procedure for the measurement of catalytic activity concentration of CK at 37 °C. It is not recommended to use this material as calibrant for routine measurement procedures. (see certification report Chapter 9.5) Commutability statement: If ERM-AD455k/IFCC would be used to calibrate routine measurement procedures, extended commutability studies should be performed with these procedures (See the certification report chapter 8.2 ).
Recommended for Publication in the JCTLM List	YES after the mistake in column R is amended Amendment made on 10/03/2022
Organization Acronym	EU - JRC
Organization Name	European Commission - Joint Research Centre
Organization Website	https://crm.jrc.ec.europa.eu/
Organization Country ISO Code	BE
Organization Country Name	Belgium
Analyte Category Name	Enzymes