Validation of the Hemo_Control instrument for determination of B-haemoglobin concentration in primary health care

Abstract

Objective: The aim of this study was to evaluate the analytical performance of a new portable haemoglobinometer, Hemo_Control (EKF-diagnostic, GmbH, Germany), which measures haemoglobin concentration in venous and capillary samples. Method: The within series and between series imprecision of the Hemo_Control instrument were calculated after measuring the concentration of venous samples under standardized conditions; by experienced laboratory technicians in a hospital laboratory, and venous and capillary samples under conditions similar to where the instrument is intended for use; by personnel at two primary health care centres. The bias of the Hemo_Control instrument was calculated as the difference between its results and results obtained with a Coulter LH 750 instrument traceable to the ICSH reference method. Results: The uncertainty of the Hemo_Control instrument for venous samples was lower than the quality goal of ± 5% considered acceptable for patient care. High within series imprecision (5.5%) was observed for measurements of capillary blood samples in one of the primary care centres, whereas adequate analytical performance was obtained at the other centre. The Hemo_Control instrument showed negligible bias of +0.8 g/L for both venous and capillary samples in primary health care. Conclusion: The observed uncertainty indicates that Hemo_Control is appropriate for near patient testing using venous samples. Capillary samples may be used if sampling skills are adequate.

Key Words::

• Analytical performance
• capillary samples
• imprecision
• method comparison
• point of care

Acknowledgements

We want to thank SKUP and especially Grete Monsen and Arne Mårtensson for the opportunity to use the data from the evaluation of Hemo_Control for the training in writing a manuscript at the Course in Manuscript Writing and Publication at Finse, February 2008. Thanks to Sverre Sandberg, Elvar Theodorsson and Tor-Arne Hagve for encouragement and supervision during writing and revision of the manuscript.

Declaration of interest: The authors report no conflict of interest. The authors alone are responsible for the content and writing of this paper.

This article is the result of the manuscripts written by each of five groups as part of the ‘Course in Manuscript Writing and Publishing’ arranged by the Editorial Board of The Scandinavian Journal of Clinical and Laboratory Investigation at Finse, Norway in February 2008. Each of the authors has contributed equally to the manuscript and their names are presented in alphabetical order in the list of authors. The data are used with permission from SKUP (Scandinavian Evaluation of Laboratory Equipment for Primary Health Care), Norway [1]