Basic study of ‘auto KL-6・BML’ of the reagent for Krebs von den Lungen (KL)-6 measurement: Reagent for sialylated carbohydrate antigen KL-6 measurement, which was the principle of latex agglutination turbidimetry

Abstract

We performed basic evaluation studies of the reagent ‘Auto KL-6・BML’ for Krebs von den Lungen-6 (KL-6) measurement based on the latex turbidimetric immunoassay. This reagent showed within-run and between-run coefficients of variation (CVs) of less than 3.7%, a detection limit of 25.2 U/mL, and also good dilution linearity. No effects from interfering substances were detected. In addition, the correlation with ‘Nanopia KL-6 Eisai’ as the comparison product whose principle of measurement is similar to that of this reagent was good (y = 0.917x − 9.5, r = 0.949, n = 194). Moreover, the correlation with the ‘HISCL KL-6 Reagent’ as the comparison product whose principle of measurement is chemiluminescent enzyme immunoassay was also good (y = 1.010x + 20.0, r = 0.914, n = 194). ‘Auto KL-6・BML’ showed sufficient reagent performance in routine tests.