PERFORMANCE EVALUATION BETWEEN TWO AUTOMATED BIOCHEMICAL ANALYZER SYSTEMS: ROCHE COBAS 8000 AND MINDRAY BS2000M

Evaluated performance of Roche Cobas 8000 and Mindray BS2000M

  • Mingxing Chen The First Affiliated Hospital of Guangxi Medical University
  • Simeng Qin The First Affiliated Hospital of Guangxi Medical University
  • Sitao Yang The First Affiliated Hospital of Guangxi Medical University
  • Huaping Chen The First Affiliated Hospital of Guangxi Medical University
  • Liuyi Lu The First Affiliated Hospital of Guangxi Medical University
  • Xue Qin The First Affiliated Hospital of Guangxi Medical University
Keywords: analytical techniques and equipment, validation, Roche Cobas 8000, Mindray BS2000M, comparison

Abstract


Summary

Background. The values of biomarkers play a central role in routine clinical decision-making. Whereas, the performances of different automated chemical analyzers remain unclear. To determine the performances of different platforms, we evaluated the capability between Roche Cobas 8000 and Mindray BS2000M. 

Methods. A total of 1869 remaining serum samples were collected. CK, LDH-1, RBP, Cys-c, IgA, IgM and IgG were assessed by using paired-t test, Passing-Bablok regression analysis and Bland Altman analysis according to CLSI EP5-A3.

Results. There were significant in average bias of all items between two machines (P < 0.001). Due to the 95% confidence interval of intercept A included 0, CK, LDH-1, Cys-c and IgG were not show systemic error in Passing-Bablok regression analysis. Except for IgA, the r values and correlation coefficient of all items were higher than 0.91, which showed that the correlation and consistency is good. The Bland-Altman analysis showed that two instruments had more than 95% of the points apart from CK, LDH-1, and IgA.

Conclusions. It can be considered that the two instruments have good correlation and consistency in CK, LDH-1, RBP, Cys-c, IgM and IgG, and the two instruments are interchangeable and can replace each other.

Author Biographies

Mingxing Chen, The First Affiliated Hospital of Guangxi Medical University

Department of Laboratory Medicine

Xue Qin, The First Affiliated Hospital of Guangxi Medical University

Department of Laboratory Medicine

References

1. Leitner-Ferenc V, Atamaniuk J, Jansen-Skoupy S, Stöckelmeier B, Grohs K, Födinger M. CLSI-Based Validation of Manufacturer-Derived Reference Intervals on the Cobas 8000 Platform. Lab Med 2017;48:e30-e35.
2. Llovet JM, Zucman-Rossi J, Pikarsky E, Sangro B, Schwartz M, Sherman M, et al. Hepatocellular carcinoma. Nat Rev Dis Primers 2016;2:16018.
3. Hijazi Z, Oldgren J, Lindbäck J, Alexander JH, Connolly SJ, Eikelboom JW, et al. The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding risk score for patients with atrial fibrillation: a derivation and validation study. Lancet 2016;387:2302-2311.
4. Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet 2010;376:687-97.
5. Lippi G, Plebani M, Favaloro EJ. Technological advances in the hemostasis laboratory. Semin Thromb Hemost 2014;40:178-85.
6. Lim J, Song KE, Song SH, Choi HJ, Koo SH, Kwon GC. Traceability Assessment and Performance Evaluation of Results for Measurement of Abbott Clinical Chemistry Assays on 4 Chemistry Analyzers. Arch Pathol Lab Med 2016;140:467-72.
7. CLSI. Evaluation of Linearity of Quantitative Measurement procedures. 2nd ed Clinical and Laboratory Standards Institute 2020; CLSI guideline EP06. .
8. Sun Y, Hu Z, Huang Z, Chen H, Qin S, Jianing Z, et al. Compare the accuracy and precision of Coulter LH780, Mindray BC-6000 Plus, and Sysmex XN-9000 with the international reference flow cytometric method in platelet counting. PLoS One 2019;14:e0217298.
9. Ciepiela O, Kotula I, Kierat S, Sieczkowska S, Podsiadlowska A, Jenczelewska A, et al. A Comparison of Mindray BC-6800, Sysmex XN-2000, and Beckman Coulter LH750 Automated Hematology Analyzers: A Pediatric Study. J Clin Lab Anal 2016;30:1128-1134.
10. Wang J, Zhao S, Su Z, Liu X. Analytical comparison between two hematological analyzer systems: Mindray BC-5180 vs Sysmex XN-1000. J Clin Lab Anal 2019;33:e22955.
11. Oudatzis G, Tsagarakis NJ, Paterakis G, Vasileiou P, Xenou E, Maraki P, et al. Evaluation of automated capillary complete blood counts for routine clinical decision making in a large cohort of hematological patients, using Mindray BC-3000 Plus Auto and Sysmex XE-5000 hematology analyzers. Int J Lab Hematol 2020;42:565-572.
12. Lapić I, Coen Herak D, Prpić S, Prce A, Raščanec V, Zadro R, et al. Verification of automated latex-enhanced particle immunoturbidimetric D-Dimer assays on different analytical platforms and comparability of test results. Biochem Med (Zagreb) 2020;30:030705.
13. Hida Y, Uemura K, Sugimoto H, Kawashima Y, Koyanagi N, Notake S, et al. Evaluation of performance of the GENECUBE assay for rapid molecular identification of Staphylococcus aureus and methicillin resistance in positive blood culture medium. PLoS One 2019;14:e0219819.
14. Nikolac Gabaj N, Miler M, Vrtaric A, Hemar M, Filipi P, Kocijancic M, et al. Precision, accuracy, cross reactivity and comparability of serum indices measurement on Abbott Architect c8000, Beckman Coulter AU5800 and Roche Cobas 6000 c501 clinical chemistry analyzers. Clin Chem Lab Med 2018;56:776-788.
15. Puissant-Lubrano B. Evaluation of Cobas 8000(R) for the quantification of albumin and IgG in serum and cerebrospinal fluid. Clin Biochem 2018;56:105-108.
16. Danese E, Montagnana M. An historical approach to the diagnostic biomarkers of acute coronary syndrome. Ann Transl Med 2016;4:194.
17. Sesso R, Santos AP, Nishida SK, Klag MJ, Carvalhaes JT, Ajzen H, et al. Prediction of steroid responsiveness in the idiopathic nephrotic syndrome using urinary retinol-binding protein and beta-2-microglobulin. Ann Intern Med 1992;116:905-9.
18. Kendrick J, Chonchol M. Cardiovascular disease in CKD in 2013: Reducing cardiovascular risk--light at the end of the tunnel. Nat Rev Nephrol 2014;10:71-2.
19. Pabst O. New concepts in the generation and functions of IgA. Nat Rev Immunol 2012;12:821-32.
20. Bunker JJ, Bendelac A. IgA Responses to Microbiota. Immunity 2018;49:211-224.
21. Berbers RM, Franken IA, Leavis HL. Immunoglobulin A and microbiota in primary immunodeficiency diseases. Curr Opin Allergy Clin Immunol 2019;19:563-570.
22. Chen K, Magri G, Grasset EK, Cerutti A. Rethinking mucosal antibody responses: IgM, IgG and IgD join IgA. Nat Rev Immunol 2020;20:427-441.
23. Ehrenstein MR, Notley CA. The importance of natural IgM: scavenger, protector and regulator. Nat Rev Immunol 2010;10:778-86.
24. Mieli-Vergani G, Vergani D, Czaja AJ, Manns MP, Krawitt EL, Vierling JM, et al. Autoimmune hepatitis. Nat Rev Dis Primers 2018;4:18017.
25. CLSI. User Verification of Precision and Estimation of Bias Approved Guideline—Third Edition. CLSI document EP15-A3. Clinical and Laboratory Standards Institute 2014;34.
26. Bland JM, Altman DG. Comparing methods of measurement: why plotting difference against standard method is misleading. Lancet 1995;346:1085-7.
27. Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res 1999;8:135-60.
28. Passing H, Bablok. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem 1983;21:709-20.
29. He S, Wang W, Zhao H, Zhang C, He F, Zhong K, et al. The Observation and Analysis of Internal Quality Control of Cystatin C in China from 2014 to 2017. Clin Lab 2018;64:1709-1718.
30. Han Z, Zhou WQ, Mao WL, Zheng WW. Sigma Metrics used to Evaluate the Performance of Internal Quality Control in a Clinical Biochemistry Laboratory. Clin Lab 2020;66.
31. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Second Edition. EP9-A2. Wayne, Pennsylvania 2002;22:19087-1898.
32. Xiaolin G. Role of substrate depletion limit parameters in BS-2000M2 automatic chemistry analysis system. Laboratory Medicine 2017;32:822-827.
Published
2021/12/15
Section
Original paper