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Licensed Unlicensed Requires Authentication Published by De Gruyter March 13, 2020

Total haemoglobin – a reference measuring system for improvement of standardisation

Denis Grote-Koska, Rainer Klauke, Patricia Kaiser, Udo Kramer, Rainer Macdonald, Dietmar Lerche, Antje Staaden, Korbinian Brand and Gerhard Schumann

Abstract

Background

Total haemoglobin (Hb) concentration in blood belongs to the most requested measurands, and the HiCN method (hemiglobincyanide) is accepted as a reference. Although the reaction principle is clearly characterised, measurement conditions and settings are not consistently defined, some of them influencing the results. An improvement of standardisation is the object.

Methods

After method optimization, measurement results between different calibration laboratories (CL) were compared with each other and also with results of the National Metrology Institute of Germany (PTB), with target values of certified reference material, within the RELA scheme, and to >1500 results from routine laboratories.

Results

Overall deviations between three CLs were ≤0.5% (n = 24 samples) in a measurement range of 20 g/L to 300 g/L. A CV of 0.4% was determined in pooled blood (1 year long-term imprecision, 99.0%–101.1% recovery of the mean). For selected measurements (n = 4 samples) the PTB participated without significant differences to three CLs, and no significant differences were observed comparing CLs to certified values of reference materials. The expanded measurement uncertainty (probability 95%) was estimated as 1.1%.

Conclusions

A reference measuring system, comprising measuring instruments and other devices, including reagents and supply, to generate reference measurement values for total Hb concentration of high accuracy and low measurement uncertainty is presented. Measurement parameters are investigated and defined. The reference measuring system is ready to offer service to EQA providers and to the IVD industry for certifying control materials or calibrators.


Corresponding author: Dr. Denis Grote-Koska, Medizinische Hochschule Hannover, Institute of Clinical Chemistry, Carl-Neuberg-Str. 1, 30625 Hannover, Germany

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: Laboratory A: Reference Institute for Bioanalytics, Foundation for Pathobiochemistry and Molecular Diagnostics, Bonn, Germany.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2019-1177).


Received: 2019-11-14
Accepted: 2020-02-11
Published Online: 2020-03-13
Published in Print: 2020-07-28

©2020 Walter de Gruyter GmbH, Berlin/Boston

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