Lab Med Online.  2017 Jul;7(3):111-119. 10.3343/lmo.2017.7.3.111.

Performance Evaluation of the JEOL BioMajesty JCA-BM6010/C Automated Clinical Chemistry Analyzer

Affiliations
  • 1Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea. ymyun@kuh.ac.kr
  • 2Department of Laboratory Medicine, VHS Medical Center, Seoul, Korea.

Abstract

BACKGROUND
JEOL BioMajesty JCA-BM6010/C (JCA-BM6010/C, JEOL Ltd., Japan) is a recently developed ultra-compact automated clinical chemistry analyzer with a throughput of 1,200 tests per hour. Here, we present the first performance evaluation of JCA-BM6010/C.
METHODS
We evaluated the precision, linearity, correlation, accuracy, and carryover of 11 analytes (ALP, ALT, AST, calcium, creatinine, GGT, glucose, LDH, total bilirubin, total protein, and uric acid) using the JEOL closed reagent (JEOL Ltd.) according to the guidelines of the Clinical Laboratory Standards Institute. Linearity was further evaluated for ALT, AST, and GGT using open reagents by Sekisui (Japan). The performance of JCA-BM6010/C was compared to that of the Roche-Hitachi Cobas 8000 c702 chemistry autoanalyzer (Cobas 8000, Roche Diagnostics, Switzerland). Its performance using open reagents from Denka Seiken (Japan), Roche, and Sekisui was also evaluated.
RESULTS
The total coefficients of variation (CV) for all analytes were 1.0–2.7%. Linearity was observed for all analytes over the entire tested analytical range (R²≥0.99). The results of JCA-BM6010/C strongly correlated (r≥0.988) with those of Cobas 8000 for all evaluated analytes except LDH (r=0.963), as well as for all open reagents. Recovery rates for creatinine, glucose, calcium, and uric acid were 96.6–101.5% and 98.7–109.3% with the JEOL exclusive and open reagents, respectively. Sample carryover was less than 0.34%.
CONCLUSIONS
JCA-BM6010/C showed acceptable performance in the precision, linearity, correlation, accuracy, and sample carryover analyses and in the method comparison. Therefore, it could be a useful routine laboratory medical analyzer.

Keyword

Analytical performance; JEOL BioMajesty JCA-BM6010/C; Evaluation
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