1. bookVolume 29 (2021): Edizione 4 (October 2021)
Dettagli della rivista
License
Formato
Rivista
eISSN
2284-5623
Prima pubblicazione
08 Aug 2013
Frequenza di pubblicazione
4 volte all'anno
Lingue
Inglese
access type Accesso libero

Atellica CH 930 chemistry analyzer versus Cobas 6000 c501 and Architect ci4100 - a multi-analyte method comparison

Pubblicato online: 22 Oct 2021
Volume & Edizione: Volume 29 (2021) - Edizione 4 (October 2021)
Pagine: 421 - 438
Ricevuto: 21 Jul 2021
Accettato: 09 Sep 2021
Dettagli della rivista
License
Formato
Rivista
eISSN
2284-5623
Prima pubblicazione
08 Aug 2013
Frequenza di pubblicazione
4 volte all'anno
Lingue
Inglese
Abstract

Large clinical laboratories often rely on multiple chemistry analyzers. However, when a new analyzer is introduced, the laboratory must establish whether the old and new methods are comparable and can be used interchangeably. In this study, we compared the newly introduced Atellica CH930 chemistry analyzer with the already established Architect ci4100 and Cobas 6000 c501 from our laboratory.

Patient samples were randomly selected from daily routine testing and a total of 22 analytes were investigated. Total error (TEobs) between test (Atellica) and comparative (Architect and Cobas) methods was calculated at relevant medical decision levels (MDL). For demonstrative purposes, the assessment of method comparability was based on three different criteria: allowable total error (TEa) derived from biological variation (BV), CLIA proficiency testing criteria for acceptable analytical performance, and CLIA-calculated Sigma metrics. These sets of analytical performance specifications were also compared, and their strengths and limitations are discussed in this paper.

Performance of Atellica CH930 against Architect ci4100 was acceptable or nearly acceptable at 82%, 95%, and 64% of the 22 investigated MDLs across 9 analytes, according to BV-TEa, CLIA-TEa, and CLIA-calculated Sigma metrics, respectively. Similarly, performance of Atellica CH930 against Cobas 6000 c501 was acceptable or nearly acceptable at 61%, 93%, and 63% of the 54 investigated MDLs across 22 analytes, according to BV-TEa, CLIATEa, and CLIA-calculated Sigma metrics, respectively. However, method comparability should not be evaluated by a “one size fits all” approach as some analytes require different criteria of acceptability, ideally based on medically allowable error and clinical outcome.

1. Rohr UP, Binder C, Dieterle T, Giusti F, Messina CG, Toerien E, et al. The value of in vitro diagnostic testing in medical practice: a status report. PLoS One. 2016;11:e0149856 DOI: 10.1371/journal. pone.0149856 Search in Google Scholar

2.Jensen AL, Kjelgaard-Hansen M. Method comparison in the clinical laboratory. Vet Clin Pathol. 2006 Sep;35(3):276-86. DOI: 10.1111/j.1939-165X.2006. tb00131.x Search in Google Scholar

3. Clinical and Laboratory Standards Institute. Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved guideline - Third Edition. Wayne, PA: Clinical and Laboratory Standards Institute, 2013. CLSI Document EP09-A3. Search in Google Scholar

4. Statland BE. Clinical Decision Levels for Laboratory Tests, Second Edition. Oradell NJ, Medical Economics Books, 1987. Search in Google Scholar

5. U.S. Centers for Medicare & Medicaid Services (CMS). Medicare, Medicaid, and CLIA programs: laboratory requirements relating to quality systems and certain personnel qualifications. Final Rule. Fed Regist 2003;16:3650-714. Search in Google Scholar

6. Ricos C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, et al. Current databases on biological variation: pros, cons and progress. Scand J Clin Lab Invest. 1999;59:491-500 DOI: 10.1080/0036551995018522910.1080/0036551995018522910667686 Search in Google Scholar

7. White GH, Farrance I; AACB Uncertainty of Measurement Working Group. Uncertainty of measurement in quantitative medical testing: a laboratory implementation guide. Clin Biochem Rev. 2004;25(4):S1-S24. Search in Google Scholar

8. Smolcic VS, Bilic-Zulle L. Normalized MEDx chart as a useful tool for evaluation of analytical quality achievements. A picture is worth a thousand words. Clin Chem Lab Med. 2013;51(5):e99-e101. DOI: 10.1515/cclm-2012-062910.1515/cclm-2012-062923241594 Search in Google Scholar

9. Sikaris K. Analytical quality - what should we be aiming for?. Clin Biochem Rev. 2008;29(Suppl 1):S5-S10. Search in Google Scholar

10. Westgard S, Bayat H, Westgard JO. Analytical Sigma metrics: A review of Six Sigma implementation tools for medical laboratories. Biochem Med (Zagreb). 2018;28(2):020502. DOI: 10.11613/BM.2018.02050210.11613/BM.2018.020502603916130022879 Search in Google Scholar

11. Ceriotti F, Fernandez-Calle P, Klee GG, Nordin G, Sandberg S, Streichert T, et al. Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference. Clin Chem Lab Med. 2017 Feb;55(2):189-194. DOI: 10.1515/cclm-2016-009110.1515/cclm-2016-009127506603 Search in Google Scholar

12. Friedecky B, Kratochvila J, Budina M. Why do different EQA schemes have apparently different limits of acceptability? Clin Chem Lab Med. 2011 Apr;49(4):743-5. DOI: 10.1515/CCLM.2011.10510.1515/CCLM.2011.10521235390 Search in Google Scholar

13. Hens K, Berth M, Armbruster D, Westgard S. Sigma metrics used to assess analytical quality of clinical chemistry assays: importance of the allowable total error (TEa) target. Clin Chem Lab Med. 2014 Jul;52(7):973-80. DOI: 10.1515/cclm-2013-109010.1515/cclm-2013-109024615486 Search in Google Scholar

14. Fasano T, Bedini JL, Fle PA, Jlaiel M, Hubbert K, Datta H, et al. Multi-site performance evaluation and Sigma metrics of 20 assays on the Atellica chemistry and immunoassay analyzers. Clin Chem Lab Med. 2019 Dec;58(1):59-68. DOI: 10.1515/cclm-2019-069910.1515/cclm-2019-069931639101 Search in Google Scholar

15. Skendzel LP, Barnett RN, Platt R. Medically useful criteria for analytic performance of laboratory tests. Am J Clin Pathol. 1985 Feb;83(2):200-5. DOI: 10.1093/ ajcp/83.2.20010.1093/ajcp/83.2.2003969959 Search in Google Scholar

16. Sandberg S, Fraser CG, Horvath AR, Jansen R, Jones G, Oosterhuis W, et al. Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med. 2015 May;53(6):833-5. DOI: 10.1515/cclm-2015-006710.1515/cclm-2015-006725719329 Search in Google Scholar

Articoli consigliati da Trend MD

Pianifica la tua conferenza remota con Sciendo