Basic performance analysis of β-Glucan Single M30 Test Wako, (1→3)-β-D-glucan measuring reagent

Abstract

The (1→3)-β-D-glucan assay used as a diagnostic aid for deep-seated mycosis has been measured by the turbidimetric time analysis method. Recently, Limsave MT-7500, which can measure the β-D-glucan using a chromogenic substrate method, has been released. Here, we report the basic performance of “β-glucan single M30 test Wako” using the chromogenic synthetic substrate method measured by Limsave MT-7500 for use in clinical examination. The chromogenic synthetic substrate method showed better results in terms of repeatability, intermediate precision, linearity, limit of determination, and influence of co-existing substances. The measurement time and non-specific reactions of this method were reduced compared to those of the turbidimetric time analysis method. The correlation between the turbidimetric time analysis method and the chromogenic synthetic substrate method in the full measuring range was determined by the passing Bablok method (y = 0.917x − 0.054 and r = 0.9562). Additionally, their positive agreement rate was 84%, negative agreement rate was 100%, the concordance rate was 87%, and there were 7 cases of discordance. Based on the case histories, we considered the possibility of BDG contamination, false-positive results of the turbidimetric time analysis method due to nonspecific reactions, and false-negative results of the chromogenic synthetic substrate method. These analysis results indicated that β-glucan single M30 test Wako using the chromogenic substrate method presented useful basic performance, which should contribute to more accurate and rapid diagnosis of deep-seated mycosis than the turbidimetric time method in clinical.