Abstract
Accurate determination of cell concentrations serves as a valuable tool to support medical diagnosis and therapy control, e.g., in haematology, immunology and transfusion medicine. Intra- and inter-laboratory comparability of measurement results is essential for patient safety. To derive the so-called “conventional quantity value” of a measurand as target value for intra- or inter-laboratory quality assurance and to establish a traceability chain to the international System of Units (SI), a primary reference measurement procedure is needed, defined as a procedure which includes a complete analysis of influence quantities and perturbing factors and a complete description of measurement uncertainties. We describe a primary reference measurement procedure for the determination of erythrocyte concentration, based on flow cytometric cell counting by impedance measurements. To correct for instrument- and sample-dependent counting loss due to random coincidences, dilution series are prepared. The reference quantity value of the cell concentration is derived by extrapolation to vanishing volume fraction of the sample in the measurement suspension. Typically, for erythrocyte and leucocyte concentrations respective uncertainties of approximately 0.75% and 2% are reached. Future developments concern the extension of the procedures validated for erythrocyte and leucocyte counting by including immunological staining and microscopic techniques.
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