Work

Investigating the Factors Affecting the Commutability of Hemoglobin A 1C Frozen Pooled Blood Materials

Year: 2025

Type: article

Abstract: ABSTRACT Background Measurement of hemoglobin A 1C (HbA 1C ) is essential for the diagnosis and treatment of diabetes mellitus (DM). Processed blood materials (PBMs), such as frozen pooled blood (FPB), are commonly used for External Quality Assessment (EQA). However, their commutability may be affected by factors such as hemolysis and matrix modification. This study evaluated FPB commutability and identified the factors influencing its performance in HbA 1C measurements. Methods HbA 1C contents in 24 clinical blood samples (CBSs) and 10 PBMs, including FPBs, single‐donor blood (SDB), and in vitro glycated blood (IGB), were analyzed using enzymatic (EN), capillary electrophoresis (CE), cation‐exchange high‐performance liquid chromatography (CE‐HPLC), turbidimetric immunoassay (TI), and boronate affinity HPLC (BA‐HPLC). EN served as the reference measurement procedure. Commutability was assessed using Deming regression and a 95% prediction interval. The hematocrit (HCT), visual appearance, plasma absorbance (PA), hemolysis index (HI), pH, and debris cells (DC) were analyzed. Results FPB1 and SDB were commutable across all measurement procedures. FPB2 and FPB4 were commutable with CE, CE‐HPLC, and TI but non‐commutable with BA‐HPLC when HbA 1C was ≥ 6.23%, as data points fell outside the tolerance limits of the Deming regression lines. Non‐commutable PBMs showed higher PA and HI along with lower pH. DC affected HbA 1C quantification using CE‐HPLC. Conclusions Hemolysis, as assessed by PA and HI, affects FPB commutability. These factors should be considered in EQA programs, particularly for BA‐HPLC. HCT and DC did not directly affect commutability; however, maintaining appropriate HCT levels and monitoring DC‐related chromatographic interference are crucial for ensuring FPB reliability in HbA 1C comparisons.

Source: Journal of Clinical Laboratory Analysis

DOI: 10.1002/jcla.70125

Authors: Kanokwan Ngueanchanthong, Napaporn Apiratmateekul, Supaporn Suparak, Nam K. Tran, Wanvisa Treebuphachatsakul

Institutions: Ministry of Public Health, Department of Medical Sciences, Naresuan University, University of Pittsburgh

Language: English

Topic: Clinical Laboratory Practices and Quality Control

Subfield: Physiology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,120