Preparation of enzyme calibration materials

Area of Science:

• Clinical enzymology
• Biochemistry
• Reference materials

Background:

• Standardization in clinical enzymology requires both reference methods and reference materials.
• While single-enzyme materials exist, a high-amount multienzyme certified reference material (MECRM) is needed.
• Validated enzyme calibrators (ECs) are essential for transferring accuracy from reference systems to patient results.

Purpose of the Study:

• To develop a multienzyme certified reference material (MECRM) for improved intermethod calibration in clinical enzymology.
• To ensure MECRM and ECs possess catalytic properties similar to human plasma enzymes.
• To experimentally validate the commutability of the reference materials with patient samples across defined analytical specificities.

Main Methods:

• Collaborative program involving IFCC, IRMM, and IFCC corporate members.
• Development of a MECRM containing amylase, ALT, AST, ALP, CK, GGT, LDH, and lipase.
• Experimental testing of material commutability, considering enzyme source, purification, matrix composition, and processing.

Main Results:

• A collaborative effort is underway to produce a MECRM and associated ECs.
• The commutability of enzyme materials is influenced by enzyme source, purification, matrix, and processing.
• The goal is to achieve a MECRM with wide and defined commutability for key clinical enzymes.

Conclusions:

• The development of a high-amount MECRM is crucial for advancing clinical enzymology standardization.
• Ensuring commutability is key to accurate and reliable patient results across different laboratory methods.
• This initiative aims to provide a vital resource for intermethod calibration, enhancing diagnostic accuracy.