ABSTRACT
Introduction -Currently, IgE blood testing requires phlebotomy that can be painful and leads to a delay in accurate diagnosis of allergies. An opportunity exists for in-office point-of-care (POC) testing to quantify patient IgE from a low-volume fingerstick blood sample. A system has been developed that performs up to 20 tests for whole protein and components in approximately 30 minutes by Kenota Health. Methods - Preliminary platform performance validation is required and Total IgE quantification (fingerstick) has been used to compare the system against a commonly used lab method (phlebotomy). 59 subjects & 10 contrived samples were tested for Total IgE on both systems. Whole blood, and plasma were analyzed using the POC and ImmunoCAP systems, respectively. The IgE measurements were compared using a Passing-Bablok regression analysis. Results - The 59 subjects were between 14-65 years old (a young population has been used successfully, but due to COVID lockdown, fewer younger subjects were available). The IgE ranged from 1 kU/L to 3500 kU/L. The Log of the IgE measurements were plotted against each other to evaluate the POC system accuracy, precision and fit. The systems aligned very well with the slope (1.015) and y-intercept (0.923) being within the Confidence interval of the data. The r2 value for the fit was 0.98. Conclusions - The data confirms that the Kenota POC system demonstrates substantially equivalent performance to ImmunoCAP. This conclusion sets the stage for a future with specific IgE quantification (whole allergen and component testing) in allergists’ offices used to guide rapid and convenient patient diagnosis. [Formula presented]