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Aberer, W; Ebner, H; Horak, F; Jarisch, R; Klein, G; Kraft, D; Kremser, M; Loidolt, D; Ludvan, M; Pohla-Gubo, G.
Quality control in the allergy laboratory--4 years Allergy Ring Trial in Austria
WIEN KLIN WOCHENSCHR. 1992; 104(7): 195-199.
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Authors Med Uni Graz:
Aberer Werner
Lang-Loidolt Doris
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Abstract:
In 1988 the Austrian Society for Allergology and Immunology initiated an external quality control program for the in vitro allergy diagnosis. In 12 mailings, 62 sera from allergic patients were sent to selected laboratories in order to determine total and antigen specific IgE according to the laboratory-specific methods. The values for total IgE varied considerably (73.9% were within +/- 1 SD, 94.3% within +/- 2 SD and 99.1% within +/- 2 SD, but only 0.9% beyond that). Sources of error were mainly attributable to inappropriate equipment and low quality reagents, but also bad test performance, with respect to personnel and the routines. In contrast, antigen specific IgE against pollen, mites, moulds, insect venoms, animal danders, drugs, parasites, environmental and food antigens revealed quite homogeneous results. Out of 1492 data, only 46 (3.1%) had to be declared as "wrong", and the variability of the RAST-classes was low. Whereas the quality of the reagents from all the different suppliers was not absolutely reliable at the beginning of the study, it improved considerably with time, as consequence of our complaints. The comparability of the methods for detecting total-IgE were non-satisfactory, whereas those for antigen specific IgE were generally good. The variety of methods employed (radio- and enzyme immunologic, fluoro- and nephelometric methods, etc.) should entail appropriate consequences, especially critical comparisons within one and the same laboratory; in addition, international standardization of the "normal" values should replace company-standards, and quality control programs for each test system before it is marketed should be mandatory. Our results confirm, that external control should be obligatory for any laboratory.(ABSTRACT TRUNCATED AT 250 WORDS)
Find related publications in this database (using NLM MeSH Indexing)
Allergens - immunology
Antibody Specificity - immunology
Austria - immunology
Epitopes - immunology
Humans - immunology
Hypersensitivity - diagnosis
Immunoglobulin E - analysis
Quality Control - analysis

Find related publications in this database (Keywords)
Invitro Allergy Diagnosis
Quality Control
RAST
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