[Apropos of the evaluation and validation of in vitro tests for measurement of specific IgE].

Allerg Immunol (Paris)

Laboratoire d'lmmuno-Allergologie, C.H.U., Angers.

Published: April 1999

The performances of the reagents for IN VITRO TESTS in Allergy, are very variable, in spite of the existence of registration procedures as well as those of national quality control. Most of the discrepancies have their origin in the choice of technologies used by the manufacturers (reaction support, raw materials, calibration, vigour of the process of execution). It follows from this that the characteristics must be understood and the limitations appreciated of the tests that are used, as well as their interpretation. Of such information that is accessible in the records of the National Control of Quality of the Medicines Agency, as well as in the studies that are done with the aim of evaluating analytical and/or clinical performance of available tests (this work is a review of the performances of most of the tests sold in France today). It stands out that the best borders on very mediocre and that it is indispensable, like the planned nomenclature of the medical biological consultations, to take into consideration the technique used to obtain a result for interpretation of the latter.

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