RESUMEN
A new point-of-care test for the determination of NT-proBNP in whole blood was developed based on the existing gold-label rapid immunoassay technology of the Roche Cardiac reader system. The novel gold-labelled monoclonal antibody recognizes NT-proBNP at amino acid sequence 27 to 31, the biotinylated polyclonal antibody recognizes sequence 39 to 50. In a model assay based upon the reference method Elecsys proBNP and with an R & D lot of the point-of-care test, this newly selected and developed combination of antibodies showed a very good correlation with the standard Elecsys proBNP assay with correlations of 0.96 or 0.94, respectively. The test was calibrated according to the existing masterlot concept of the Roche CARDIAC tests with Elecsys proBNP as a reference. In a preliminary method comparison with Elecsys proBNP the accuracy of the calibration was confirmed; the bias was between 1 and 6%. Possible reasons of approximately 1% outliers (> +/- 100%) were discussed.
Asunto(s)
Insuficiencia Cardíaca/sangre , Insuficiencia Cardíaca/diagnóstico , Péptido Natriurético Encefálico/sangre , Fragmentos de Péptidos/sangre , Sistemas de Atención de Punto/normas , Juego de Reactivos para Diagnóstico , Anticuerpos , Especificidad de Anticuerpos , Calibración , Humanos , Control de Calidad , Juego de Reactivos para Diagnóstico/normas , Reproducibilidad de los ResultadosRESUMEN
Analyzers for in-vitro diagnostic (IVD) testing facilitate the determination of medical information from biological samples. To reach a high quality, the detection reagents have to be dispensed with a high degree of precision and accuracy. A technology change from conventional pipetting systems to contact-free dispensers provides the opportunity to reduce carry-over and handle reagents in the microliter range. A great challenge for the development and validation of new systems is the huge variety of the IVD reagents. This work presents the fluidic properties of 646 different aqueous IVD reagents and how they can be represented by a set of easy-to-prepare model fluids, covering the rheological range of the reagents. In addition, based on the model fluids, a standardized approach is presented for the evaluation of dispensers for IVD applications.