The impact of analytical variation of hemoglobin measurement on blood donors' hemoglobin and deferral rates.

ABSTRACT

BACKGROUND: Donors' hemoglobin (Hb) level must be tested before blood donation. Low Hb is the leading reason for donor deferral. Many donor-related and external factors associated with low Hb are known, but no studies have been conducted concerning the effects of analytical variation on donor Hb measurements and deferrals. STUDY DESIGN AND METHODS: The effects of donors' age, the seasonal and daily distribution of donations, and batch-to-batch variation in HemoCue Hb 201+ cuvettes on donors' capillary Hb (cHb) measurements and deferrals were analyzed for more than 1.7 million donor visits in 2010 to 2016 at a national blood establishment. Furthermore, approximately 3.1 million cHb measurements from the years 2000 to 2009 were included in analyses to correlate measured cHb value and Hb deferral rate. RESULTS: A significant correlation between the mean annual cHb and Hb deferral rate was observed in both women and men. The season of the donation was the strongest explanatory factor for the monthly variation of predonation cHb (explaining 25 and 31% of the variation in women and men, respectively). Batch-to-batch variation in HemoCue cuvettes explained 6.8% of monthly variation in women and 7.4% in men. Monthly changes in donors' age distribution explained 2.5% of monthly variation in women and 2.4% in men. CONCLUSION: Small and, in most clinical settings, negligible analytical variation in Hb measurement methods can have significant consequences when used for Hb screening of blood donors. This should be minimized by using methods in which analytical variation is under control and kept as low as possible.