Six years of INSTAND e. V. sIgE proficiency testing: An evaluation of in vitro allergy diagnostics.

BACKGROUND: Even though allergies are an important health issue, wide manufacturer-dependent differences in the detected amounts of allergen-specific IgE (sIgE) have repeatedly been found. These discrepancies hinder diagnostics and research into clinically significant cutoff points for life-threatening symptoms.

METHODS: To evaluate whether the reported differences have led to changes in diagnostic testing, we analyzed data from six years of round robin testing (RRT, also known as proficiency testing) at the Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e.V.  (Society for Promoting Quality Assurance in medical Laboratories) for the important allergen sources bee venom, wasp venom, and birch pollen. The results of the four main suppliers of in vitro diagnostic sIgE testing were compared in a pseudo-anonymized form using overlay images of box plot graphs for the semiquantitative data and allergen class results. Coefficients of variation (CV) were obtained to study the development of interlaboratory comparability.

RESULTS: We found that the large differences between the manufacturer collectives remained constant between January 2010 and April 2015 without any real improvement. The CVs were good for two of the four analyzed suppliers, one was marginal and one above the quality level of 20%.

CONCLUSION: The numerous publications that have found discrepancies in the sIgE results of the different suppliers did not change the status quo within the last six years. Unfortunately, this is unlikely to change until there is a characterized standard material with known values of sIgE.