BACKGROUND: Different laboratory assays are used to detect and measure specific IgE antibodies. No standard exists to assess their analytic performance. OBJECTIVE: We sought to analyze reported specific IgE results from different laboratories on the same serum samples for their accuracy and precision. METHODS: Blinded serum samples (26) containing variable levels of specific IgE to 17 common aeroallergens were sent on 3 different occasions through normal channels to 6 laboratories that used 5 different test procedures. Six samples were presented as a dilution series. Laboratory-assay performance was assessed by analyzing the reported results (n = 12, 708) by using ordinary least squares regression with slope coefficients, the t statistic, SEs, confidence intervals, and R (2) values. These were compared with a theoretic ideal assay as the reference. RESULTS: Analysis revealed that one system used in two different laboratories performed nearly as well as the ideal standard, with an overall average slope (0.97; range, 0.91-1.01), SE (0.05; range, 0.02-0.16), R (2) value (93%; range, 0.64-0.99), and coefficient of variation (10.3%; range, 6%-14%). Extensive variability was observed in the other 4 laboratory-assay systems with respect to overall average slope (0.76; range, 0.11-1.24), SE (0.19; range, 0.03-0.95), R (2) value (53%; range, 0.00-0.98), and coefficient of variation (19%; range, 5%-49%). For some specific allergens, some laboratories-assays were not able to detect serial dilutions of the same sample. CONCLUSIONS: One commercial system used in two different laboratories performed nearly as well as the ideal standard. Four of the laboratories-assays for specific IgE antibodies demonstrated substandard overall performance with multiple instances of poor precision and accuracy, particularly for certain allergens, such as weeds and molds.
BACKGROUND: Different laboratory assays are used to detect and measure specific IgE antibodies. No standard exists to assess their analytic performance. OBJECTIVE: We sought to analyze reported specific IgE results from different laboratories on the same serum samples for their accuracy and precision. METHODS: Blinded serum samples (26) containing variable levels of specific IgE to 17 common aeroallergens were sent on 3 different occasions through normal channels to 6 laboratories that used 5 different test procedures. Six samples were presented as a dilution series. Laboratory-assay performance was assessed by analyzing the reported results (n = 12, 708) by using ordinary least squares regression with slope coefficients, the t statistic, SEs, confidence intervals, and R (2) values. These were compared with a theoretic ideal assay as the reference. RESULTS: Analysis revealed that one system used in two different laboratories performed nearly as well as the ideal standard, with an overall average slope (0.97; range, 0.91-1.01), SE (0.05; range, 0.02-0.16), R (2) value (93%; range, 0.64-0.99), and coefficient of variation (10.3%; range, 6%-14%). Extensive variability was observed in the other 4 laboratory-assay systems with respect to overall average slope (0.76; range, 0.11-1.24), SE (0.19; range, 0.03-0.95), R (2) value (53%; range, 0.00-0.98), and coefficient of variation (19%; range, 5%-49%). For some specific allergens, some laboratories-assays were not able to detect serial dilutions of the same sample. CONCLUSIONS: One commercial system used in two different laboratories performed nearly as well as the ideal standard. Four of the laboratories-assays for specific IgE antibodies demonstrated substandard overall performance with multiple instances of poor precision and accuracy, particularly for certain allergens, such as weeds and molds.
Authors: Adnan Custovic; Lars Soderstrom; Staffan Ahlstedt; Peter D Sly; Angela Simpson; Patrick G Holt Journal: J Allergy Clin Immunol Date: 2011-04-13 Impact factor: 10.793
Authors: Rocio L Espinosa; María Fe Laguna; Fátima Fernández; Beatriz Santamaria; Francisco Javier Sanza; Maria Victoria Maigler; Juan J Álvarez-Millán; Víctor Canalejas-Tejero; Miguel Holgado Journal: Sensors (Basel) Date: 2018-08-15 Impact factor: 3.576
Authors: Martin Raithel; Markus Hahn; Konrad Donhuijsen; Alexander F Hagel; Andreas Nägel; Ralf J Rieker; Markus F Neurath; Max Reinshagen Journal: Nutr J Date: 2014-09-17 Impact factor: 3.271