Fundamental evaluation of “Nanopia^®KL-6 EISAI” kit for measurement of KL-6 using LABOSPECT 008

Abstract

The basic performance of the KL-6 measurement kit “Nanopia^® KL-6 EISAI” was evaluated using LABOSPECT 008, a general-purpose automatic analyzer. The coefficients of variation (CVs) for the within-run and between-run reproducibilities ranged from 0.88% to 1.75%. The dilution linearity was maintained at about 5,000 U/mL, and the detection limit was 16.0 U/mL. No effect of interfering substances was detected. The KL-6 concentrations determined by the current and conventional methods showed a good correlation in 52 samples (r = 0.995, y = 1.03x − 40.0). Therefore, this kit, which has good basic performance using the LABOSPECT 008, is useful for testing before consultation and as an emergency test.