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Total haemoglobin - a reference measuring system for improvement of standardisation
Denis Grote-Koska1, Rainer Klauke1,2, Patricia Kaiser3
1Medizinische Hochschule Hannover, Institute of Clinical Chemistry, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.
Clinical Chemistry and Laboratory Medicine
|March 14, 2020
Summary
Standardizing total hemoglobin (Hb) measurements using the hemiglobincyanide (HiCN) method improves accuracy. A new reference system ensures consistent, high-precision Hb concentration results, benefiting quality control and diagnostics.
Area of Science:
- Clinical Chemistry
- Metrology
- Biomedical Engineering
Background:
- Total hemoglobin (Hb) concentration is a critical blood measurand.
- The hemiglobincyanide (HiCN) method is the established reference technique.
- Inconsistent measurement conditions affect Hb result accuracy.
Purpose of the Study:
- To improve the standardization of total Hb concentration measurements.
- To establish a reference measuring system for accurate Hb determination.
- To define critical measurement parameters for the HiCN method.
Main Methods:
- Method optimization and inter-laboratory comparisons between calibration laboratories (CLs).
- Comparison with the National Metrology Institute of Germany (PTB) and certified reference materials.
- Analysis of over 1500 routine laboratory results within the RELA scheme.
Main Results:
- Inter-CL deviations were ≤0.5% across a wide measurement range (20-300 g/L).
- Long-term imprecision showed a coefficient of variation (CV) of 0.4% with excellent recovery.
- Expanded measurement uncertainty was determined to be 1.1% (95% probability).
Conclusions:
- A validated reference measuring system for total Hb concentration has been developed.
- Defined measurement parameters ensure high accuracy and low uncertainty.
- The system is prepared to support external quality assurance (EQA) and the IVD industry.
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