Évaluation analytique de la trousse ST AIA-PACK 27.29 (équivalent CA 15-3) de Tosoh bioscience sur l'automate AIA 21 et comparaison avec la trousse AIA-PACK 27.29 VIDAS CA 15-3 bioMérieux, AXSYM CA-15-3 Abbott

Abstract

We report here evaluation results from analytical features related to ST-AIA PACK 27.29 (10 minutes incubation time format) which measures MUC-1 protein, a breast tumour marker; and results' comparison versus a pool of 113 patients with, in one hand, 2 others methods used (VIDAS CA15.3 and AXSYM CA 15.3) and on the other hand, a third method (AIA PACK 27.29, a 40 minutes incubation time format, used in our daily routine lab. Systems used are AIA 21 and VIDAS, both installed within our Hospital lab and AXSYM, installed in the city commercial lab. The “SFBC VALTEC protocol – version 1997 – 2000” has been followed with all those tests. The Results of the evaluation tests, repeatability, reproducibility, dilution, correlation for ST-AIA PACK 27.29, are fully compliant with VALTEC criteria. Assay range for this kit is from 1 to 400 U/ml. Results from different correlations between ST AIA-PACK 27.29 and AIA PACK 27.28 are Y = 0.84X – 0.18 (r = 0.98), and Axsym are Y = 0.76X + 0.34 (r = 0.97) and Vidas are Y = 0.92 X + 0.24 (r = 0.92). As conclusion, the performed method gives results with acceptable analytical criteria, compliant with the current state of the art, and correlated with the 2 others methods used. The analytical system allowing performing this kit highlights the main advantages of the AIA machines line as far as quality insurance is concerned: Pipetting thanks to individual tips directly onto the primary tube, use of unitary tests cups which guarantee excellent reagents stability and flexibility are the main points of interest and to be taken into account.