Current Status of Measurement Accuracy for Total Hemoglobin Concentration in the Clinical Context

Abstract

Objective: The main objective of this investigation is to provide data about the accuracy of total hemoglobin concentration measurements with respect to clinical settings, and to devices within the categories of point-of-care and reference systems. In particular, tolerance of hemoglobin concentrations below 9 g/dL that have become common in clinical practice today determines the need to demonstrate the limits of measurement accuracy in patient care. Methods: Samples extracted from six units of heparinized human blood with total hemoglobin concentrations ranging from 3 to 18 g/dL were assigned to the test devices in a random order. The pool of test devices comprised blood gas analyzers, an automatic hematology analyzer, a laboratory reference method, and the point-of-care system HemoCue. To reduce the pre-analytic error, each sample was measured three times. Due to the characteristics of the tested devices and methods, we selected the mean values of the data from all these devices, measured at the corresponding total hemoglobin concentrations, as the reference. Main results: The measurement results of the test devices overlap within strict limits (R2 = 0.999). Only the detailed analysis provides information about minor but systematic deviations. In the group of clinically relevant devices, which are involved in patient blood management decisions, the relative differences were within the limit of +/− 5 % for values down to 3 g/dL. Conclusions: A clinically relevant change of +/− 0.5 g/dL of total hemoglobin concentration can be detected with all selected devices and methods. Compliance with more stringent definitions—these are the relative differences of 5 % in relation to the corresponding reference values and the clinically adapted thresholds in the format of a tolerance level analysis—was achieved by the clinical devices assessed here.