John Libbey Eurotext

Annales de Biologie Clinique


Quality specifications and allowable limits for validation of methods used in clinical biochemistry Volume 57, issue 6, Novembre - Décembre 1999


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Hôpital Necker-Enfants malades, 149, rue de Sèvres, 75743 Paris cedex 15
  • Key words: Allowable limits - Quality specifications - Method validation - Acceptability.
  • Page(s) : 685-95
  • Published in: 1999

The purpose of this work is to provide, for a large number of analysis in the field of clinical biochemistry, appropriate criteria for the evaluation of the performance of in vitro diagnostic methods. Based on a first set of data established in 1986 and the experience cumulated by organisers in charge of internal and external quality assessment surveys, an expert group has proposed acceptable limits for a large list of analysis (n = 116). Data are reported and presented in tables divided into 7 chapters including: general biochemistry, enzymes, proteins, tumour markers, hormones, drugs (and toxic), and urinary analysis. For each analysis are given: analytical and reference ranges, three concentration levels for control specimens to be used during evaluations and the range of values within which they can be chosen, reproducibility and repeatability limits expressed as CV%. Maximal tolerable systematic error and inaccuracy are given for control and biological specimens and compared to those obtained using a reference or validated method. These data are essential for evaluations using the protocol designed by the SFBC and can serve as quality criteria for the choice and validation of in vitro diagnostic systems.