Total haemoglobin – a reference measuring system for improvement of standardisation

Grote-Koska, Denis; Klauke, Rainer; Kaiser, Patricia; Kramer, Udo; Macdonald, Rainer; Lerche, D.; Staaden, Antje; Brand, Korbinian; Schumann, G.

doi:10.1515/cclm-2019-1177

Cited by 6 publications

(3 citation statements)

References 15 publications

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“…10 The JCTLM lists certified reference procedures (CRPs) in their database for total HGB measurement (since 2021). 11 The ICSH and other professional organizations have previously recommended testing methods that represent the best laboratory practice for cell counting and measurement of HGB concentration at the time. 12,13 IQC materials for the blood count (FBC/CBC) were traditionally prepared within the laboratory 2 ; however, the challenges associated with these procedures mean that commercially prepared controls are now the control materials of choice.…”

Section: Historical Perspectivementioning

confidence: 99%

“…The haemoglobincyanide (HiCN) standard introduced in 1967 9 markedly improved the accuracy of haemoglobin (HGB) measurement and at the time of writing, remains the only certified reference material (CRM) applicable to the blood count (full blood count, FBC, or complete blood count, CBC) and being evaluated by the Joint Committee for Traceability in Laboratory Medicine (JCTLM) 10 . The JCTLM lists certified reference procedures (CRPs) in their database for total HGB measurement (since 2021) 11 . The ICSH and other professional organizations have previously recommended testing methods that represent the best laboratory practice for cell counting and measurement of HGB concentration at the time 12,13…”

Section: Introductionmentioning

confidence: 99%

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ICSH review of internal quality control policy for blood cell counters

McCafferty,

Cembrowski,

de la Salle

et al. 2024

Int J Lab Hematology

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IntroductionThis paper is a report of an ICSH review of policies and practices for internal quality control (IQC) policy for haematology cell counters among regulatory bodies, cell counter manufacturers and diagnostic laboratories. It includes a discussion of the study findings and links to separate ICSH guidance for such policies and practices. The application of internal quality control (IQC) methods is an essential pre‐requisite for all clinical laboratory testing including the blood count (Full Blood Count, FBC, or Complete Blood Count, CBC).MethodsThe ICSH has gathered information regarding the current state of practice through review of published guidance from regulatory bodies, a questionnaire to six major cell counter manufacturers (Abbott Diagnostics, Beckman Coulter, Horiba Medical Diagnostic Instruments & Systems, Mindray Medical International, Siemens Healthcare Diagnostics and Sysmex Corporation) and a survey issued to 191 diagnostic laboratories in four countries (China, Republic of Ireland, Spain and the United Kingdom) on their IQC practice and approach to use of commercial IQC materials.ResultsThis has revealed diversity both in guidance and in practice around the world. There is diversity in guidance from regulatory organizations in regard to IQC methods each recommends, clinical levels to use and frequency to run commercial controls, and finally recommended sources of commercial controls. The diversity in practice among clinical laboratories spans the areas of IQC methods used, derivation of target values and action limits used with control materials, and frequency of running commercial controls materials.ConclusionsThese findings and their implications for IQC Practice are discussed in this paper. They are used to inform a separate guidance document, which proposes a harmonized approach to address the issues faced by diagnostic laboratories.

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Section: Historical Perspectivementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

ICSH review of internal quality control policy for blood cell counters

McCafferty,

Cembrowski,

de la Salle

et al. 2024

Int J Lab Hematology

View full text Add to dashboard Cite

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“…The resulting filtrate can then be collected and the pH measured using a pH meter (SevenDirect SD20 LowVol Kit, METTLER TOLEDO, USA) and the concentrations of hemoglobin and its methemoglobin have been determined using the HiCN method. 20,21 Animal Experiment…”

Section: Characterization Of Polyhbmentioning

confidence: 99%

Solid-Phase Polymerization Using Anion-Exchange Resin Can Almost Completely Crosslink Hemoglobin to Prepare Hemoglobin-Based Oxygen Carriers

Wang¹,

Mu²,

Zhao³

et al. 2023

IJN

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Introduction:A limitation of hemoglobin-based oxygen carriers (HBOCs) as oxygen therapeutics is unpolymerized hemoglobin, which induces vasoconstriction leading to hypertension. The removal of unpolymerized hemoglobin from polymerized hemoglobin (PolyHb) is complex, expensive, and time-consuming. Methods: Herein, we developed a method to completely polymerize hemoglobin almost without unpolymerized hemoglobin. Hemoglobin was adsorbed on the anion-exchange resin Q Sepharose Fast Flow or DEAE Sepharose Fast Flow, and acetal, a crosslinker prepared from glutaraldehyde and ethylene glycol, was employed to polymerize the hemoglobin. The polymerization conditions, including reaction time, pH, resin type, and molar ratios of glutaraldehyde to ethylene glycol and hemoglobin to acetal, were optimized. The blood pressure and blood gas of mice injected with PolyHb were monitored as well. Results:The optimal polymerization condition of PolyHb was when the molar ratio of glutaraldehyde to ethylene glycol was 1:20, and the molar ratio of 10 mg/mL hemoglobin adsorbed on anion-exchange resin to glutaraldehyde was 1:300 for 60 min. Under optimized reactive conditions, hemoglobin was almost completely polymerized, with <1% hemoglobin remaining unpolymerized, and the molecular weight of PolyHb was more centrally distributed. Furthermore, hypertension was not induced in mice by PolyHb, and there were also no pathological changes observed in arterial oxygen, blood gas, electrolytes, and some metabolic indicators. Conclusion:The findings of this study indicate that the use of solid-phase polymerization and acetal is a highly effective and innovative approach to HBOCs, resulting in the almost completely polymerized hemoglobin. These results offer promising implications for the development of new methods for preparing HBOCs.

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