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Kim, Jeong, Lee, Chun, and Min: Performance Evaluation of the Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer
Original Article
Clinical Chemistry

Laboratory Medicine Online 2014; 4(3): 132-139.

Published online: 1 July 2014

DOI: https://doi.org/10.3343/lmo.2014.4.3.132

Performance Evaluation of the Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer

So-Young Kim, M.D.1, Tae-Dong Jeong, M.D.2, Woochang Lee, M.D.2, Sail Chun, M.D.2, Won-Ki Min, M.D.2

1Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.

2Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea.

Corresponding author: Won-Ki Min. Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 138-736, Korea. Tel: +82-2-3010-4503, Fax: +82-2-478-0884, wkmin@amc.seoul.kr

Received 21 May 2013       Revised 18 October 2013       Accepted 18 November 2013

© 2014, Laboratory Medicine Online

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

Optimal operational efficiency requires specific technical solutions such as open, flexible, and adaptable space, suitable equipment requirements, and laboratory instrumentation that combine excellent analytical performance with a capacity for testing large panels in a high throughput manner, under rapid turnaround times. Thus, the aim of this study was to assess the analytical performance of the novel Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer.

Methods

Precision, linearity, carry over, detection limits, and comparison studies were performed with 31 routine clinical chemistry tests according to the CLSI guidelines. Commercial quality chemistry control material (Lyphochek, Bio-Rad, USA) and patient sera were used as the test specimens. Unicel DxC instrument (Beckman Coulter, USA) was used as a control analyzer to evaluate the correlation.

Results

The total coefficients of variations (CVs) of almost all the analytes were between 0.4 and 4.1%, except for CO2 and ammonia. Excellent linearities were observed in the performance ranges used (r>0.99, slope, 0.961-1.048). Correlations with analogous tests ran on the Unicel DxC instrument were good, correlation coefficients ranging between 0.921 and 1.000. The carryover ranged from -0.216 to 0.481%.

Conclusions

The Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer showed satisfactory precision, linearity, carry over, detection limits, and high throughput capacity. The instrument performance correlated well with the Unicel DxC analyzer. We conclude that the balance of elevated throughput and optimal analytical performance should make Roche-Hitachi cobas c702 Chemistry Autoanalyzer suitable for very large clinical laboratories.

Keywords: Analytical performance, Roche-Hitachi cobas 8000 c702, Evaluation

Figures and Tables

Table 1
Precision of the Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer
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Table 2
Linearity of the Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer
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Table 3
Correlation of the Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer
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Table 4
Carryover of the Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer
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Table 5
Detection limits of the Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer
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Notes

This article is available from http://www.labmedonline.org

References

1. Brombacher PJ, Marell GJ, Westerhuis LW. Laboratory workflow analysis and introduction of a multifunctional analyzer. Eur J Clin Chem Clin Biochem. 1996; 34:287–292.
2. Vap LM. An update on chemistry analyzers [Review]. Vet Clin North Am Small Anim Pract. 1996; 26:1129–1154.
3. Park SS, Ma SJ, Maeng KY. Evaluation of automated chemistry analyzer: Chem 1. J Clin Pathol Qual Control. 1989; 11:97–103.
4. Park JS, Chun S, Min WK. Evaluation of automated chemistry analyzer Synchron LX20. Korean J Clin Pathol. 2000; 20:163–170.
5. Kim MY. Evaluation of automated chemistry analyzer ISP-1000. J Clin Pathol Qual Control. 1997; 18:333–338.
6. Kim JQ. Evaluation of automated chemistry analyzer Cobas Bio. J Clin Pathol Qual Control. 1984; 6:53–60.
7. Clinical and Laboratory Standards Institute. NCLSI document EP5-A2. Evaluation of precision performance of quantitative measurement methods; approved guideline. 2nd ed. Wayne PA: Clinical and Laboratory Standards Institute;2004.
8. Clinical and Laboratory Standards Institute. CLSI document EP6-A. Evaluation of linearity of quantitative measurement procedures; a statistical approach. 2nd ed. Wayne PA: Clinical and Laboratory Standards Institute;2003.
9. Clinical and Laboratory Standards Institute. CLSI document EP9-A2. Method comparison and bias estimation using patient samples; approved guideline. 2nd ed. Wayne PA: Clinical and Laboratory Standards;2002.
10. Clinical and Laboratory Standards Institute. CLSI document EP17-A. Protocols for determination of limits of detection and limits of quantification; approved guideline. Wayne PA: Clinical and Laboratory Standards Institute;2002.
11. Cho SE, Nam JW, Hong KS. Performance Evaluation of the Hitachi 7600-110 Chemistry Autoanalyzer. Korean J Clin Pathol. 2001; 21:331–337.
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