Quality criteria for the detection of analytes in test samples : with special reference tot anabolic agents and related compounds

W.G. de Ruig, R.W. Stephany, G. Dijkstra

Research output: Book/ReportReportProfessional

Abstract

Analytical results serve a purpose and this can always be defined in terms of a decision to be taken. Examples are classifying a material according to value, or safety decisions such as ''no action required, all is well", The nature of the decision determines the requirements put to the analysis such as the quantitative ones, e.g. limits of detection, or the qualitative ones, e.g. amount of certainty, that the identification of a compound is unambiguous. The classical approach to unambiguity is a detailed description of procedures. However, this approach has some drawbacks. A standard method by virtue of its immobility is apt to become old-fashioned. Modern highly sophisticated apparatus ask for dedicated analytical procedures, which are not generally applicable. Changes in custom-made reagents or equipment force adaptation of the procedure. For quantitative analysis the flexibility can be attained by a system of quality parameters. These are inadequate for qualitative analysis. In order to create a system in which well-defined limits of ambiguity can be set we have introduced the concept of "quality criteria" to be applied to the identification method(s) used. The quality criteria for each detection method have to be stated and adopted by a board of experts for that detection method. But, once an analysis fulfils the adopted criteria of a detection method, the presence of the investigated analyte in the sample can be taken as proved within the limits of ambiguity chosen for the decision process. In particular for spectrometric identification methods such quality criteria are of essential interest. Quality criteria are presented for low resolution MS, high resolution MS, IR, on line spectrometric detection with TLC and HPLC, furthermore for off line separation techniques (GC, TLC, HPLC), as well as general considerations for the whole analytical procedure. The criteria are incorporated in the EEC ''Commission Decision of 14 July 1987 laying down the methods to be used for detecting residues of substances having a hormonal action and substances having a thyrostatic action". Throughout this report, some differences with respect to the EEC text occur.
Original languageEnglish
Place of PublicationWageningen
PublisherRIKILT
Number of pages36
Publication statusPublished - 1987

Publication series

NameRapport / RIKILT
No.87.27
NameRIVM rapport
No.368301 001

Keywords

  • chemical analysis
  • analytical methods
  • samples
  • quality standards
  • food quality

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    de Ruig, W. G., Stephany, R. W., & Dijkstra, G. (1987). Quality criteria for the detection of analytes in test samples : with special reference tot anabolic agents and related compounds. (Rapport / RIKILT; No. 87.27), (RIVM rapport; No. 368301 001). Wageningen: RIKILT.