Yuko Okuyama1, Yosuke Doi2, Naoto Matsuyama2, Michiyo Uchino3, Takayuki Yamamoto4. 1. Diagnostic R&D, Alfresa Pharma Corporation, Osaka, Japan. Electronic address: afp-ibaraki-rc@alfresa-pharma.co.jp. 2. Diagnostic R&D, Alfresa Pharma Corporation, Osaka, Japan. 3. Department of Clinical Laboratory, Yokkaichi Hazu Medical Center, Yokkaichi, Japan. 4. Inflammatory Bowel Disease Center, Yokkaichi Hazu Medical Center, Yokkaichi, Japan.
Abstract
BACKGROUND: We introduce a new assay method to measure the concentration of fecal calprotectin that can be applied in exclusive analyzers. The assay method uses gold colloidal reagents. In addition, we report performance evaluation results for the new method and the results of comparisons with enzyme-linked immunosorbent assay (ELISA) methods. METHODS: We evaluated the new method by linearity tests and within-run tests. In addition, we collected specimens from patients with a definitive diagnosis of inflammatory bowel disease (n=566) and examined them using the new method. The results were compared with those from 2 commercially available ELISA kits. RESULTS: In the linearity tests, the correlation coefficients between the measured values and the theoretical values were 0.9980-0.9990. In the within-run tests, the CVs were 3.4-4.3%. The correlation coefficients for our method and the 2 ELISA kits showed high correlations of 0.945 and 0.942. CONCLUSIONS: Our assay is capable of measuring calprotectin concentrations in feces, and has a similar performance to commercially available ELISA methods. Our method is an automated assay system, which is an easier, cheaper, and quicker measurement method than conventional ELISA kits. Therefore, our assay is suitable for daily clinical use.
BACKGROUND: We introduce a new assay method to measure the concentration of fecal calprotectin that can be applied in exclusive analyzers. The assay method uses gold colloidal reagents. In addition, we report performance evaluation results for the new method and the results of comparisons with enzyme-linked immunosorbent assay (ELISA) methods. METHODS: We evaluated the new method by linearity tests and within-run tests. In addition, we collected specimens from patients with a definitive diagnosis of inflammatory bowel disease (n=566) and examined them using the new method. The results were compared with those from 2 commercially available ELISA kits. RESULTS: In the linearity tests, the correlation coefficients between the measured values and the theoretical values were 0.9980-0.9990. In the within-run tests, the CVs were 3.4-4.3%. The correlation coefficients for our method and the 2 ELISA kits showed high correlations of 0.945 and 0.942. CONCLUSIONS: Our assay is capable of measuring calprotectin concentrations in feces, and has a similar performance to commercially available ELISA methods. Our method is an automated assay system, which is an easier, cheaper, and quicker measurement method than conventional ELISA kits. Therefore, our assay is suitable for daily clinical use.
Authors: Ferdinando D'Amico; David T Rubin; Paulo Gustavo Kotze; Fernando Magro; Britta Siegmund; Taku Kobayashi; Pablo A Olivera; Peter Bossuyt; Lieven Pouillon; Edouard Louis; Eugeni Domènech; Subrata Ghosh; Silvio Danese; Laurent Peyrin-Biroulet Journal: United European Gastroenterol J Date: 2021-05-07 Impact factor: 4.623