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

• Kim HN
• Ji M
• Moon HW
• Hur M
• Yun YM

• KMID: 2383089
• DOI: http://doi.org/10.3343/lmo.2017.7.3.111

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 (R²â‰¥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

MeSH Terms

Bilirubin
Calcium
Chemistry
Chemistry, Clinical*
Creatinine
Glucose
Indicators and Reagents
Methods
Uric Acid
Bilirubin
Calcium
Creatinine
Glucose
Indicators and Reagents
Uric Acid

Figure

• 

  Fig. 1. Comparison of the results of 50 ALP, calcium, and creatinine tested using the JCA-BM6010/C and Cobas 8000. (A) Correlation between JCA-BM6010/C and Cobas 8000. Red bold line, ordinary Deming regression; red dotted line, 95% confidence interval; gray line, identity line. (B) Difference between JCA-BM6010/C and Cobas 8000. Blue bold line, mean difference between values; gray dotted lines, desirable specification for allowable total error. Abbreviation: ALP, alkaline phosphatase.

• 

  Fig. 2. Comparison of the results of 50 ALP, Calcium, Creatinine, and LDH using open reagents and the JEOL closed reagent on the same JCA-BM6010/C instrument. (A) Correlation between the open reagents and JEOL closed reagents. Red bold line, ordinary Deming regression; red dotted line, 95% confidence interval; gray line, identity line. (B) Difference between the open reagents and JEOL closed reagents. Blue bold line, mean difference between values; gray dotted lines, desirable specification for allowable total error. Abbreviations: ALP, alkaline phosphatase; LDH, lactate dehydrogenase

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