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

“Molecular extracts” for allergy diagnostics and therapy

“…However, the exact qualitative and quantitative composition of this type of extract is poorly determined. Products with a similar label from different manufacturers produce different results in the same patient . This implies that the clinical decision taken by the doctor is strongly dependent on the composition of the allergen extract used for diagnosis.…”

“…It is not surprising that the wheal reaction elicited by allergen extracts of the same pollen or mite species in the individual patient is highly influenced by the manufacturer . Similarly, part of the variability in the outcome of in vitro IgE tests to the extracts of the same allergen source is probably dependent on the extract composition . In conclusion, the standardization of allergen extracts for diagnosis and therapy is still an open issue in Allergology …”

“…Products with a similar label from different manufacturers produce different results in the same patient. [5][6][7][8][9] This implies that the clinical decision taken by the doctor is strongly dependent on the composition of the allergen extract used for diagnosis. B, Molecular Extract-like Preparation-So-called "molecular extracts" are pre-defined mixes of all the relevant allergen molecules of a given allergen source (eg, Phleum pratense) so far identified and cloned.…”

“…[6][7][8] Similarly, part of the variability in the outcome of in vitro IgE tests to the extracts of the same allergen source is probably dependent on the extract composition. 9 In conclusion, the standardization of allergen extracts for diagnosis and therapy is still an open issue in Allergology. 5 Recently, new European regulations established that allergen extracts for in vivo diagnostics (eg, SPT) must undergo the same registration procedures as those used for the equivalent therapeutic products.…”

Quality management in IgE-based allergy diagnostics

“…These findings illustrate the urgent need of general harmonization (between IgE assays) and further improvement in laboratory performance for those assaying IgE samples. In contrast, INSTAND provides their proficiency survey results only to its customers; comparative long-term data have been prepared for publication [33].…”