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

Hyeong Nyeon Kim; Misuk Ji; Hee-Won Moon; Mina Hur; Yeo-Min Yun

doi:10.3343/lmo.2017.7.3.111

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Kim, Ji, Moon, Hur, and Yun: Performance Evaluation of the JEOL BioMajesty JCA-BM6010/C Automated Clinical Chemistry Analyzer

Original Article

Lab Med Online 2017;7(3):111-119.

Published online: 17 July 2017

DOI: https://doi.org/10.3343/lmo.2017.7.3.111

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

Hyeong Nyeon Kim, M.D.¹, Misuk Ji, M.D.², Hee-Won Moon, M.D.¹, Mina Hur, M.D.¹, Yeo-Min Yun, M.D.^1,

¹Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea

²Department of Laboratory Medicine, VHS Medical Center, Seoul, Korea

Corresponding author: Yeo-Min Yun Department of Laboratory Medicine, Konkuk University School of Medicine Konkuk University Hospital, 120-1 Neungdong-ro, Gwangjin-gu, Seoul 05030, Korea Tel: +82-2-2030-5582, Fax: +82-2-2030-5587, E-mail: ymyun@kuh.ac.kr

Received 5 July 201617 September 2016 Accepted 26 September 2016

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

Keywords: Analytical performance, JEOL BioMajesty JCA-BM6010/C, Evaluation

REFERENCES

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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

Table 1.

Precision profiles of JEOL BioMajesty JCA-BM6010/C for the 11 analytes using two levels of control material^∗

Analytes	Level	Mean concentration	CV (%)				Desirable precision criteria (%)^†	Roche total CV^‡ (%)	Beckman total CV^§ (%)	CVw^† (%)
Analytes	Level	Mean concentration	Repeatability	Between-run	Between-day	Total	Desirable precision criteria (%)^†	Roche total CV^‡ (%)	Beckman total CV^§ (%)	CVw^† (%)
ALP (IU/L)	Low	95.1	0.7	0.7	1.2	1.5	3.2	3.0	2.0	6.5
	High	603.7	0.9	0.3	2.2	2.4		2.5	1.8
ALT (IU/L)	Low	25.0	2.1	1.6	0.6	2.7	9.7	3.6	2.7	19.4
	High	190.6	0.8	0.0	1.7	1.9		1.6	1.8
AST (IU/L)	Low	42.5	0.7	0.5	1.1	1.4	6.2	1.5	1.9	12.3
	High	250.9	0.7	0.3	0.8	1.1		3.5	1.4
Calcium (mg/dL)	Low	6.1	1.1	0.6	0.8	1.5	1.1	1.5	1.2	2.1
	High	13.6	0.8	0.0	0.9	1.2		1.4	1.2
Creatinine (mg/dL)	Low	0.7	0.9	0.5	1.1	1.5	3.0	3.0	3.0	6.0
	High	7.0	0.8	0.4	0.6	1.1		2.4	1.9
GGT (IU/L)	Low	30.1	1.6	1.2	0.8	2.1	6.7	2.1	1.3	13.4
	High	141.3	0.6	0.3	0.7	1.0		1.1	0.8
Glucose (mg/dL)	Low	62.4	0.9	0.7	0.8	1.4	2.8	1.3	1.4	5.6
	High	360.2	0.9	0.5	1.0	1.4		1.3	1.4
LDH (IU/L)	Low	111.2	0.7	0.3	1.8	2.0	4.3	1.5	1.9	8.6
	High	374.6	0.7	0.3	1.4	1.6		1.6	1.5
Total bilirubin (mg/dL)	Low	0.6	1.7	1.0	1.2	2.3	10.9	3.3	1.1	21.8
	High	6.4	0.8	0.5	1.6	1.8		1.8	1.0
Total protein (g/dL)	Low	3.9	0.6	0.3	0.8	1.0	1.4	1.2	1.1	2.8
	High	6.8	0.5	0.7	0.9	1.3		1.6	1.1
Uric acid (mg/dL)	Low	3.4	0.8	1.0	1.5	1.7	4.3	1.2	1.6	8.6
	High	9.7	0.8	0.3	0.9	1.2		1.2	1.5

^∗ Liquid Assayed Multiqual (human serum based) Level 1 and Level 2 (Bio-Rad Laboratories Inc., Hercules, CA, USA);

^† Within-subject biological variation and desirable analytical precision criteria are referred from the biological variation database specification on the Westgard web site (http://www.westgard.com/biodatabase1.htm) [4];

^‡ Total CV of Roche-Hitachi Cobas 8000 c702 chemistry autoanalyzer [5];

^§ Total CV of Beckman Coulter AU5822 automated clinical chemistry analyzer [6]. Abbreviations: ALP, alkaline phosphatase; ALT, alanine transaminase; AST, aspartate aminotransferase; CV, coefficient of variation; CVw, within-subject biologic variation; GGT, gamma-glutamyl transferase; LDH, lactate dehydrogenase.

Table 2.

Linearity^∗ of the 11 analytes by using JCA-BM6010/C with JEOL closed reagents

Analytes	Linear range specified by the serum specimen manufacturer	Test range	Observed linear range	Slope	Intercept	R²	Recovery (%)
ALP (IU/L)	10-6,500	0.0-8,868.5	0.0-8,868.5	0.94	26.11	0.999	93-100
ALT (IU/L)^†	8-2,200	0.1-2,306.0	0.1-2,306.0	0.94	19.01	0.999	100-104
AST (IU/L)^†	6-1,500	0.7-1,463.3	0.7-1,463.3	0.94	18.73	0.999	93-100
Calcium (mg/dL)	2.0-25.0	0.1-26.0	0.1-26.0	1.00	0.02	0.999	99-101
Creatinine (mg/dL)	0.5-45.0	0.2-35.9	0.2-35.9	1.00	0.03	1.000	100-109
GGT (IU/L)^†	8-4,000	1.1 -3,684.0	1.1 -3,684.0	0.91	20.30	0.999	90-100
Glucose (mg/dL)	15-850	6.9-690.0	6.9-690.0	0.96	7.11	0.998	77-101
Lactate dehydrogenase (IU/L)	12-3,000	0.0-3,966.5	0.0-3,966.5	0.93	23.44	0.999	93-100
Total bilirubin (mg/dL)	0.2 -27.0	0.1-29.1	0.1-29.1	1.04	-0.10	0.999	96-104
Total protein (g/dL)	up to 14 g/dL	0.6-14.7	0.6-14.7	0.96	0.14	0.999	96-100
Uric acid (mg/dL)	1.0-75.0	1.9-29.6	1.9-29.6	1.01	-0.08	0.999	100-101

^∗ The linearity was performed according to the CLSI EP6-A;

^† ALT, AST, and GGT were also evaluated using the Sekisui open reagent. Specified linear ranges by the Sekisui were as follows: ALT (0.0–1,500.0, IU/L), AST (0.0–1,500.0, IU/L), GGT (0.0–2,000.0, IU/L). Test ranges and observed linear ranges were as follows: ALT (0.0–1,816.8, 0.0–1,816.8, IU/L), AST (0.6–1,697.9, 0.6–1,697.9, IU/L), GGT (0.0–1,628.0, 0.0–1,628.0, IU/L). Abbreviations: ALP, alkaline phosphatase; ALT, alanine transaminase; AST, aspartate aminotransferase; GGT, gamma-glutamyl transferase.

Table 3.

Comparison results between the Cobas 8000 analyzer and JCA-BM6010/C (n=50)^∗

Analytes	Test range	Correlation coefficient (r)^† (95% CI)	Slope^‡ (95% CI)	Intercept^‡ (95% CI)	Mean difference (95% CI)
ALP	38.3-1418.3	0.999 (0.999-1.000)	3.40 (3.34-3.47)	3.20 (-10.8-17.2)	458.4 (242.7-674.0)
ALT	1.8-209.1	0.995 (0.991-0.997)	1.16 (1.07-1.26)	0.70 (-1.36-2.77)	5.6 (3.0-8.2)
AST	6.7-445.9	0.999 (0.999-1.000)	1.08 (1.06-1.11)	-0.31 (-1.28-0.66)	5.1 (2.5-7.6)
Calcium	6.8-14.1	0.988 (0.978-0.993)	1.05 (0.97-1.14)	-0.22 (-0.97-0.54)	0.3 (0.2-0.3)
Creatinine	0.5-18.7	0.991 (0.984-0.995)	0.95 (0.83-1.07)	-0.04 (-0.24-0.16)	-0.2 (-0.3-0.0)
GGT	6.9-1893.3	0.999 (0.998-1.000)	1.05 (0.98-1.13)	9.96 (1.99-17.92)	18.9 (12.0-25.9)
Glucose	64.8-460.1	0.999 (0.999-1.000)	0.99 (0.98-1.00)	1.86 (0.39-3.33)	-0.5 (-1.5-0.4)
LDH	57.6-1049.5	0.963 (0.937-0.979)	1.04 (0.96-1.13)	7.65 (-18.54-33.84)	18.7 (5.2-32.2)
Total bilirubin	0.1-22.4	0.998 (0.997-0.999)	0.98 (0.91-1.05)	-0.01 (-0.10-0.09)	-0.1 (-0.1-0.0)
Total protein	3.5-9.5	0.995 (0.991-0.997)	1.00 (0.97-1.04)	-0.17 (-0.40-0.07)	-0.1 (-0.2-0.10)
Uric acid	0.4-14.9	0.999 (0.999-1.000)	1.00 (0.99-1.01)	0.03 (-0.01-0.08)	0.1 (0.0-0.1)

^∗ The comparison was performed according to the CLSI EP9-A2-IR;

^† Figures using the Pearson's correlation coefficient;

^‡ Figures using Deming regression plot analysis. “Mean difference” is defined as measured figures of each JCA-BM6010/C minus Cobas 8000. Abbreviations: ALP, alkaline phosphatase; ALT, alanine transaminase; AST, aspartate aminotransferase; GGT, gamma-glutamyl transferase; LDH, lactate dehydrogenase.

Table 4.

Comparison results between other open reagents and JEOL closed reagents in the same JCA-BM6010/C instrument (n=50)^∗

Analytes	Manufacturer of reagents	Test range	Correlation coefficient (r)^† (95% CI)	Slope^‡ (95% CI)	Intercept^‡ (95% CI)	Mean difference (95% CI) (Open reagent-JEOL closed reagent)
ALP	Roche	21.7-343.1	0.998 (0.996-0.999)	3.01 (2.86-3.15)	9.78 (-1.90-21.45)	222.6 (183.4-261.8)
ALT	Sekisui	2.5-131.2	0.999 (0.998-0.999)	1.02 (1.01-1.03)	-3.41 (-3.85–2.97)	-3.0 (-3.3–2.7)
AST	Roche	7.0-134.6	0.999 (0.999-1.000)	0.99 (0.97-1.00)	-0.41 (-0.85-0.03)	-0.8 (-1.1–0.6)
Calcium	Sekisui	8.0-11.7	0.978 (0.962-0.988)	1.01 (0.96-1.07)	0.55 (0.03-1.07)	0.7 (0.6-0.7)
Creatinine	Roche	0.7-14.1	0.999 (0.998-0.999)	1.00 (0.98-1.02)	-0.26 (-0.31–0.20)	-0.3 (-0.3–0.2)
GGT	Sekisui	13.0-535.2	0.999 (0.999-1.000)	0.95 (0.93-0.97)	2.09 (1.39-2.79)	-0.9 (-2.4-0.6)
Glucose	Denka Seiken	35.0-436.5	0.999 (0.999-1.000)	1.00 (0.99-1.01)	0.05 (-0.82-0.93)	0.1 (-0.2-0.5)
LDH	Denka Seiken	248.7-3276.3	0.996 (0.993-0.998)	0.46 (0.46-0.47)	3.33 (-3.95-10.62)	-307.5 (-378.7–236.3)
Uric acid	Sekisui	0.1-13.9	0.999 (0.998-0.999)	1.03 (1.00-1.06)	-0.23 (-0.40–0.05)	-0.03 (-0.1-0.0)

^∗ The comparison was performed according to the CLSI EP9-A2-IR;

^† Figures using Pearson's correlation coefficient;

Table 5.

Accuracy^∗ of the 4 analytes using JCA-BM6010/C with JEOL closed reagents and other^‡ reagents

Analytes	Target±Uncertainty (SRM)^†	Mean value (Recovery, %)		Desirable bias (%)^§	Minimum bias (%)^II	Optimum bias (%)^II
Analytes	Target±Uncertainty (SRM)^†	JEOL	Other^‡	Desirable bias (%)^§	Minimum bias (%)^II	Optimum bias (%)^II
Creatinine (mg/dL)	0.89±0.03 (JCCRM 521-12M)	0.86 (96.6)	0.97 (109.3)	3.96	5.94	1.98
	2.20±0.09 (JCCRM 521-12H)	2.18 (99.0)	2.24 (101.7)
	5.31±0.21 (JCCRM 521-12HH)	5.32 (100.2)	5.28 (99.5)
Glucose (mg/dL)	100.10±1.00 (JCCRM 521-12M)	100.23 (100.1)	100.55 (100.4)	2.34	3.51	1.17
	150.20±1.60 (JCCRM 521-12H)	149.83 (99.8)	150.83 (100.4)
	249.80±2.6 (JCCRM 521-12HH)	251.70 (100.8)	251.03 (100.5)
Calcium (mg/dL)	9.37±0.14 (JCCRM 321-7M)	9.50 (101.4)	9.25 (98.7)	0.82	1.23	0.41
	12.00±0.18 (JCCRM 321-7H)	12.18 (101.5)	11.87 (98.9)
Uric acid (mg/dL)	5.50±0.08 (JCCRM 521-12M)	5.42 (98.5)	5.54 (100.7)	4.87	7.31	2.44
	8.08±0.11 (JCCRM 521-12H)	8.02 (99.3)	8.12 (100.5)
	11.99±0.23 (JCCRM 521-12HH)	11.92 (99.4)	12.09 (100.8)

^∗ The accuracy was performed with certified standard materials∗ for each of the three levels according to the CLSI EP15-A2;

^† All standard materials are certified (JCCRM 521 and JCCRM 321);

^‡ Other tested reagents are manufactured by Roche for creatinine, Denka Seiken for glucose, and Sekisui for calcium and uric acid;

^§ Desirable bias are from the biological variation database specification on the Westgard website (http://www.westgard.com/biodatabase1.htm) [4];

^II Minimum bias and optimum bias are calculated using a previously reported equation by Ricós et al. and Biswas et al. [4, 13].

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