Total haemoglobin – a reference measuring system for improvement of standardisation
| Autor: | Gerhard Schumann, Antje Staaden, Udo Kramer, Rainer Macdonald, Dietmar Lerche, Rainer Klauke, Korbinian Brand, Patricia Kaiser, Denis Grote-Koska |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
030213 general clinical medicine
Biochemistry (medical) Clinical Biochemistry General Medicine 030204 cardiovascular system & hematology Metrology Hemoglobins 03 medical and health sciences % total haemoglobin 0302 clinical medicine CLs upper limits Certified reference materials Reference measurement Reference Values Statistics Measuring instrument Calibration Humans Measurement uncertainty Laboratories |
| Zdroj: | Clinical Chemistry and Laboratory Medicine (CCLM). 58:1314-1321 |
| ISSN: | 1437-4331 1434-6621 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|