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AbstractAbstract
[en] The aim of this work was to devise a quality check procedure for radioimmunological analyses, easily applicable in all laboratories. The parameters most commonly analysed during such a test are: non-specific activity; total binding capacity; reproducibility; sensitivity; accuracy; specificity; specific activity of the labelled substance; affinity constant of the antigen towards its specific antibody. In the method proposed the calibration curve of any series of measurements is established by Rodbard's method. For the reproducibility study the use of Ekins' method, modified by Grillet and Marchand, was preferred. From the results obtained it is possible to plot the error-response relationship (ERR) and to establish the accuracy profile which gives a good idea of the sensitivity of the analysis method. For the specificity study this method matches the usual operational conditions as closely as possible. The determination is made on the following mixture: a half-volume (with respect to the usual volume) of biological liquid studied and previously analysed for cold antigen Ag0; a half-volume of one of the dilutions prepared with the substance X liable to interfere during the Ag0 determination. Any interferences between the substance X and the antigen are then plotted on a graph representing: as abscisse, the concentration of substance X; as ordinates, the difference between the measured and theoretical Ag0 concentrations. This very simple representation shows the interference threshold of each substance X; accounting for its physiopathological concentration
[fr]
On a mis au point un protocole de controle de qualite des dosages radio-immunologiques facilement applicable dans tous les laboratoires. Les parametres les plus couramment analyses au cours d'un tel controle sont: l'activite non specifique; - la capacite totale de liaison; - la reproductibilite; - la sensibilite; - l'exactitude; - la specificite; - l'activite specifique de la substance marquee; - la constante d'affinite de l'antigene vis-a-vis de son anticorps specifique. Dans le protocole propose la courbe d'etalonnage de toute serie de dosages est etablie selon la methode de Rodbard. Lors de l'etude de la reproductibilite, on a prefere utiliser la methode D'Ekins, modifiee par Grillet et Marchand. Les resultats obtenus permettent de tracer la relation erreur-reponse (RER), puis d'etablir le profil de precision qui donne une bonne determination de la sensibilite de la methode de dosage. En ce qui concerne l'etude de la specificite, la methode proposee se situe dans des conditions operatoires aussi proches que possible des conditions habituelles. La technique consiste a effectuer le dosage sur un melange constitue par: - un demi-volume (par rapport au volume habituel) de liquide biologique etudie et prealabement dose en antigene froid Ag0; - un demi-volume d'une des dilutions preparees avec la substance X susceptible d'interferer au cours du dosage de Ag0. Les eventuelles interferences entre la substance X et l'antigene sont ensuite representees graphiquement en portant: - en abscisse: les concentrations de la substance X; - en ordonnee: la difference entre les concentrations mesurees et les concentrations theoriques d'Ag0. Ce mode de representation, tres simple, met en evidence le seuil d'interference de chaque substance X en tenant compte des concentrations physiopathologiques de cette derniereOriginal Title
Controle de qualite des dosages radioimmunologiques et validation methodologique du dosage de la beta-2-microglobuline
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Apr 1980; 143 p; These (D. Pharm.).
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Miscellaneous
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Thesis/Dissertation
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