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Haemoglobin A₁c measurement in patients with chronic kidney disease
Insights
Carbamylated hemoglobin (cHb) may not significantly interfere with hemoglobin A1c (HbA1c) measurements in chronic kidney disease (CKD) patients using common chromatography methods. However, results require caution in patients with high cHb levels.
Area of Science:
- Clinical Chemistry
- Nephrology
- Analytical Biochemistry
Background:
- Hemoglobin A1c (HbA1c) is a key biomarker for glycemic control.
- Chronic kidney disease (CKD) patients exhibit elevated urea levels, potentially leading to hemoglobin carbamylation (cHb).
- Carbamylated hemoglobin (cHb) may interfere with HbA1c assays, impacting diabetes management in CKD patients.
Purpose of the Study:
- To investigate the interference of carbamylated hemoglobin (cHb) on HbA1c measurements.
- To evaluate three ion-exchange chromatography methods for HbA1c testing in CKD patients.
- To assess the impact of varying urea concentrations on HbA1c results in CKD.
Main Methods:
- Analyzed HbA1c in 152 CKD patients using three ion-exchange (Bio-Rad Variant II, G7, HA-8160) and one affinity chromatography (Primus Ultra2) method.
- Performed in vitro hemoglobin carbamylation to assess interference.
- Utilized repeated measures ANOVA to compare HbA1c values across methods.
Main Results:
- No statistically significant differences in HbA1c values were observed between the four methods for non-diabetic and diabetic CKD patients (P=0.421 and P=0.336, respectively).
- Increasing blood urea concentrations from stage 3 to stage 5 CKD did not correlate with increased HbA1c values.
- In vitro carbamylation demonstrated that carbamylated hemoglobin peaks were identifiable by the ion-exchange methods.
Conclusions:
- Ion-exchange chromatography methods for HbA1c measurement appear robust against carbamylated hemoglobin interference in CKD patients.
- Clinical interpretation of HbA1c results in CKD patients with potentially high cHb levels warrants careful consideration.
- Further studies may be needed to fully elucidate the clinical significance of cHb in HbA1c assays for CKD populations.
Objectives:
The aim of this study is to investigate the interference of carbamylated haemoglobin (cHb) to haemoglobin A1c (HbA₁c) measurements in patients with chronic kidney disease (CKD) by three ion-exchange chromatography methods.
Design And Methods:
We included three ion-exchange chromatography methods (Bio-Rad Variant II, G7 and HA-8160) and one affinity chromatography method (Primus Ultra2) to test HbA₁c. In vitro carbamylation of haemoglobin was also performed to test interference of carbamylation.
Results:
152 CKD patients were diagnosed. The average HbA₁c and urea levels of nondiabetic and diabetic patients were 5.24% (33.8 mmol/mol) and 7.36% (56.9 mmol/mol) and 16.2 mmol/L and 11.2 mmol/L, respectively. Repeated measures ANOVA showed that the difference of HbA₁c values between four methods is not statistically significant (P=0.421 for non-DM and P=0.336 for DM). With the increase in blood urea concentration from stage 3 to stage 5, there was no corresponding increase in HbA1c values for both groups. In vitro carbamylation results showed that carbamylated Hb peaks could be clearly identified by the three ion-exchange methods.
Conclusion:
HbA1c measurement by these methods may not be impacted by carbamylated Hb. The results should be interpreted with caution in high carbamylated Hb patients.
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