Standardization and harmonization in hematology: Instrument alignment, quality control materials, and commutability...

Area of Science:

• Clinical Laboratory Science
• Hematology
• Analytical Chemistry

Background:

• Hub and spoke laboratory networks require robust hematology analyzer (HA) alignment for consistent analytical quality.
• Increased numbers of HAs necessitate reliable methods for ensuring instrument comparability.

Purpose of the Study:

• To evaluate a protocol for aligning hematology analyzers (HAs) using quality control (QC) material instead of fresh whole blood.
• To assess the commutability of QC materials for various hematology parameters.

Main Methods:

• Five HAs were aligned using a SIBioC protocol, comparing human samples (HS) and QC materials.
• Commutability was verified per the IFCC protocol, with maximum bias derived from biological variation data.
• Evaluated parameters included red blood cell (RBC), white blood cell (WBC), and platelet (PLT) series.

Main Results:

• Complete alignment was observed for most parameters using both HS and QC materials.
• Partial misalignments or inconclusive results occurred for specific parameters like MCV, MO, EO, BA, and IG.
• Quality control (QC) material showed non-commutability for LY, MO, and BA parameters.

Conclusions:

• Hematology analyzer (HA) alignment for main cell populations can be effectively verified using both QC and HS materials.
• Critical evaluation is needed for certain white blood cell parameters (EO, BA, IG) due to material limitations.
• Careful selection and validation of QC materials are essential for accurate HA alignment.