Lab Med Online.  2014 Jul;4(3):132-139. 10.3343/lmo.2014.4.3.132.

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

• Kim SY
• Jeong TD
• Lee W
• Chun S
• Min WK

• KMID: 1706849
• DOI: http://doi.org/10.3343/lmo.2014.4.3.132

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.

Keyword

Analytical performance; Roche-Hitachi cobas 8000 c702; Evaluation

MeSH Terms

Ammonia
Chemistry*
Clinical Chemistry Tests
Humans
Limit of Detection
Ammonia

Reference

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.