2019 Volume 68 Issue 3 Pages 486-493
[Introduction] We evaluated the analytical performance of Lumipulse L2400 (Fujirebio Co., Ltd.) in the detection of HBsAg-HQ, KL-6, and 8 tumor markers (CEA, CA19-9, AFP, CA125, CA15-3, PSA, CYFRA, and PIVKA-II). We assessed the correlation of the false positive rates of HBsAg-HQ for 5 months in routine testing and the turn-around-time (TAT) of CEA between Lumipulse L2400 and Lumipulse G1200. [Results] The within-run and between-run coefficients of variation (CVs) of all the reagents ranged from 0.0% to 6.2% in pooled serum and a control sample (n = 10). The limits of detection and quantitation (at 10% CV) were equivalent to those in the accompanying documents of reagents provided by the manufacturers, and the assay results for the serially diluted pooled serum showed excellent linearity for all the reagents. Lumipulse L2400 strongly correlated with Lumipulse G1200 within a measurement range for all the reagents (r = 0.99). For the PIVKA-II reagent, the interdevice correlation up to 100 mAU/mL (r = 0.961) was slightly lower than that with higher values (r = 0.99). There was a good reproducibility with automated 1:200 or 1:1000 dilution in a device with pooled serum or a calibrator sample (CV = 0.9–3.0%; n = 10), and the 1:1000 dilution assay showed measurements from 95.2% to 113.7% compared with manual dilution. The false positive rates of HBsAg-HQ among all HBsAg-HQ orders with Lumipulse L2400 and Lumipulse G1200 were 0.11% and 0.15%, respectively. The average TAT in Lumipulse L2400 was shortened by 7 min and the number of TATs up to 60 min was improved from 73.5% to 94.3%. [Conclusion] These results showed that Lumipulse L2400 is useful for routine measurements.
