Reference Measurements Procedure

The CIRME adopts test methods recommended by national and international organizations (http://www.bipm.org/en/committees/jc/jctlm/jctlm-db) or, when these are not available or in response to specific requests of the customer, draws up its own methods that are submitted to adequate validation. With regard to the procedures adopted in various stages of testing, where possible, methods supported by relevant scientific publications are used.

The reference methods currently used are indicated in the following table:

ANALYTE ANALYTICAL PROCEDURE REFERENCE METHOD REFERENCE Alanine aminotransferase (ALT) Kinetic spectrophotometry IFCC Reference Measurement Procedure (37°C) for ALT Schumann G et al. Clin Chem Lab Med 2002;40:718-24 Alkaline phosphatase (ALP) Kinetic spectrophotometry IFCC Reference Measurement Procedure (37°C) for ALP Schumann G et al. clin chem Lab Med 2011;49:1439-46 Aspartate aminotransferase (AST) Kinetic spectrophotometry IFCC Reference Measurement Procedure (37°C) for AST Schumann G et al., Clin Chem Lab Med 2002;40:725-33 Creatine kinase (CK) Kinetic spectrophotometry IFCC Reference Measurement Procedure (37°C) for CK Schumann G et al. Clin Chem Lab Med 2002;40:635-42 Gamma-glutamyltransferase (GGT) Kinetic spectrophotometry IFCC Reference Measurement Procedure (37°C) for GGT Schumann G et al. Clin Chem Lab Med 2002;40:734-8 Lactate dehydrogenase(LDH) Kinetic spectrophotometry IFCC Reference Measurement Procedure (37°C) for LDH Schumann G et al. Clin Chem Lab Med 2002;40:643-8 Glycated Haemoglobin(HbA1c) HPLC – capillary electrophoresis IFCC Reference Measurement Procedure for HbA1c Jeppsson JO et al. Clin Chem Lab Med 2002; 40:78-89. Glucose spectrophotometry CDC Hexokinase reference method for glucose Neese JW et al. HEW Publication No. (CDC) 1976;77-8330. Centre for Disease Control, Atlanta, USA

The reference measurement procedures are designed, described, and applied so that traceability of results to higher reference procedures or higher reference materials is achieved with the stated level of uncertainty of measurement.

ANALYTE	ANALYTICAL PROCEDURE	REFERENCE METHOD	REFERENCE
Alanine aminotransferase (ALT)	Kinetic spectrophotometry	IFCC Reference Measurement Procedure (37°C) for ALT	Schumann G et al. Clin Chem Lab Med 2002;40:718-24
Alkaline phosphatase (ALP)	Kinetic spectrophotometry	IFCC Reference Measurement Procedure (37°C) for ALP	Schumann G et al. clin chem Lab Med 2011;49:1439-46
Aspartate aminotransferase (AST)	Kinetic spectrophotometry	IFCC Reference Measurement Procedure (37°C) for AST	Schumann G et al., Clin Chem Lab Med 2002;40:725-33
Creatine kinase (CK)	Kinetic spectrophotometry	IFCC Reference Measurement Procedure (37°C) for CK	Schumann G et al. Clin Chem Lab Med 2002;40:635-42
Gamma-glutamyltransferase (GGT)	Kinetic spectrophotometry	IFCC Reference Measurement Procedure (37°C) for GGT	Schumann G et al. Clin Chem Lab Med 2002;40:734-8
Lactate dehydrogenase(LDH)	Kinetic spectrophotometry	IFCC Reference Measurement Procedure (37°C) for LDH	Schumann G et al. Clin Chem Lab Med 2002;40:643-8
Glycated Haemoglobin(HbA1c)	HPLC – capillary electrophoresis	IFCC Reference Measurement Procedure for HbA1c	Jeppsson JO et al. Clin Chem Lab Med 2002; 40:78-89.
Glucose	spectrophotometry	CDC Hexokinase reference method for glucose	Neese JW et al. HEW Publication No. (CDC) 1976;77-8330. Centre for Disease Control, Atlanta, USA