Development and Evaluation of Hemoglobin Control Materials for Point-of-Care Hemoglobinometer

Abstract

A point-of-care (POC) hemoglobinometer has been widely used in blood donor selection because of its convenience, quantitative measurement of hemoglobin, and availability of quality control. HemoCue, with its own quality control materials provided, was one of the most common devices used worldwide. However, commercial control materials were expensive and required overseas purchase and distribution. The aim of this study was to produce internal quality control materials from expired donated blood samples and further evaluation by using a POC hemoglobinometer, HemoCue Hb 301. Expired donated blood samples were mixed with preservative materials, aliquoted and adjusted the hemoglobin concentrations to 3 levels (low, medium and high). The two productions of control materials were prepared with different hemoglobin concentrations. Subsequently, all control materials were assessed for homogeneity in accordance with ISO Guide 80:2014, prior to packaging and distributed to 4 certified blood banks complied with the Laboratory Accreditation of the Medical Technology Council. Stability and Levey-Jennings chart (L-J Chart) of internal quality control were examined in 4 certified blood banks for 30 days. The results showed that the homogeneity of all control materials was acceptable, as evidenced by one-way ANOVA with a 95% confident level. In addition, degree of stability determined for a period of at least 1 month at 4 °C were acceptable, with the linear regression slope of stability. We observed the L-J Chart out of control 1_3s at two sites and out of control 1_2s for all four sites. Trends were detected at Site B (Lot. 1) and Site C (Lot. 2) on the 12^th to 30^th consecutive days, demonstrating interference of the analysis. These results might be caused by random errors. In conclusion, the produced control materials were valid for the internal quality control of a point-of-care hemoglobinometer for a month. However, further study on the stability and performance assessment of various commercial point-of-care hemoglobinometers is needed.