Evaluation of the clinical chemistrytests analytical performance by usingdifferent models and specifications
Yıl: 2020 Cilt: 45 Sayı: 1 Sayfa Aralığı: 11 - 18 Metin Dili: İngilizce DOI: 10.1515/tjb-2018-0250 İndeks Tarihi: 02-10-2021
Evaluation of the clinical chemistrytests analytical performance by usingdifferent models and specifications
Öz: Background: The importance of managing analytical quality in clinical laboratories is known. Goal-setting models are critical for analytical quality management, along with correctly implemented error models. However, the methods used to determine analytical performance and more importantly, the relevant analytical quality goals are open to discussion. Our aim was to compare the analytical performance characteristics of routine clinical chemistry tests with different goal-setting models which was pro-posed by various establishments. In addition, to provide a perspective to Turkish total analytical error (TAE) circular letter that compulsory to calculate from 2016.Materials and methods: This study was performed by the data obtained from the internal and external quality control of clinical chemistry tests which were measured by Roche Cobas c501 biochemistry analyzer. TAE calcu-lated with TAE% = 1.65 ×(CV%) + Bias% formula. Nordtest uncertainty model was used in the calculation of meas-urement uncertainty (MU). In this context, total analytical error was evaluated with biological variation (BV), RCPA, CLIA and Turkish allowable total error (ATE) goals. Meas-urement uncertainty was evaluated with only permissible measurement uncertainty (pU%) goal.Results: In our study, RCPA goals are the most strin-gent, followed by the BVEuBIVAS, BVRicos, pU%, CLIA and finally the ATETurkey goals coming in last. In cumulatively, BVEuBIVAS goals were 18.3% lower than BVRicos for evaluated parameters.Conclusion: The balance between applicability and ana-lytical assurance of goals should be well ensured when determining goal-setting models. Circular letter (2016/18) creates awareness to the analytical quality manage-ment but still open to development. Biological variation dependent total allowable error model never designed to be used as benchmarks for measurement uncertainty and it is not methodologically appropriate for assessing meas-urement uncertainty which was estimated by the Nordtest method. Also considered that, the use of “permissible MU” is more methodologically appropriate in the evaluation of measurement uncertainty.
Anahtar Kelime: Klinik kimya testlerinin analitik performansının farklı modeller ve spesifikasyonlar kullanılarak değerlendirilmesi
Öz: Amaç: Klinik laboratuvarlarda analitik kalite yönetimi- nin önemi bilinmektedir. Analitik kalite yönetimindedoğru uygulanan hata modelleriyle birlikte amaca uygunolarak seçilen hedef belirleme modelleri kritik bir önemesahiptir. Ancak, analitik performansı belirlemek için kul- lanılan yöntemler ve daha da önemlisi, ilgili hedef belir- leme modelleriyle alakalı tartışmalar günümüzde devametmektedir. Çalışmamızda, rutin klinik kimya testlerininanalitik performans karakteristiklerini çeşitli kuruluşlartarafından önerilen farklı hedef belirleme modelleri ilekarşılaştırmayı amaçladık. Ayrıca, ülkemizde 2016 yılın- dan itibaren uygulanmaya başlanan toplam analitik hatamodeline bir bakış açısı sağlamayı amaçladık. Gereç ve Yöntem: Çalışmamız, Roche Cobas c501 biyo- kimya analizörü kullanılarak elde edilen iç ve dış kalitekontrol verileriyle gerçekleştirilmiştir. Toplam analitik hataTAH% = 1.65 ×(CV%) + Bias% formülü ile hesaplanmıştır.Ölçüm belirsizliği Nordtest kılavuzuna bağlı kalınarakhesaplanmıştır. Toplam analitik hata biyolojik varyasyon(BV), RCPA, CLIA ve Türkiye izin verilen toplam hata hedef- leriyle, ölçüm belirsizliği ise sadece ilgili kalite hedefi olanAlman Klinik Kimya ve Laboratuvar Tıp Derneği izin verile- bilir ölçüm belirsizliği (%pU) ile değerlendirildi. Sonuç: Çalışmamızda, en zorlayıcı hedef belirleme mode- linin RCPA olduğu ve bunu sırasıyla BVEuBIVAS, BVRicos, %pU,CLIA ve son olarak da Türkiye izin verilen hata genelgesi sınır- larının olduğunu gözlemlendi. Biyolojik Varyasyon temellimodeller incelendiğinde, BVEuBIVAS hedeflerinin değerlendiri- len parametreler için BVRicos’dan kümülatif olarak %18,3 ora- nında daha zorlayıcı hedefler belirlediği gözlemlendi. Tartışma: Analitik kalite hedefleri belirlenirken, hedef- lerin uygulanabilirliği ile analitik güvencesi arasındakidenge iyi sağlanmalıdır. İzin verilen toplam hata genel- gesi (2016/18), ülkede analitik kalite yönetiminde farkın- dalık sağladığı, ancak yine de gelişime açık noktalarınbulunduğu düşünülmektedir. Biyolojik varyasyona bağlıtoplam izin verilen hata modellerinin ölçüm belirsizli- ğini değerlendirmek için bir kriter olarak tasarlanmadığıve Nordtest yöntemiyle hesaplanan ölçüm belirsizliğinideğerlendirmek için metodolojik olarak uygun olmadığıdüşünülmektedir. Ölçüm belirsizliğinin değerlendirilme- sinde “İzin verilebilir ölçüm belirsizliğinin” kullanılma- sının metodolojik olarak uygun olduğu düşünülmektedir.
Anahtar Kelime: Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık
- 1. Westgard JO. Useful measures and models for analytical quality management in medical laboratories. Clin Chem Lab Med 2016;54:223–33.
- 2. Westgard JO, Carey RN, Wold S. Criteria for judging precision and accuracy in method development and evaluation. Clin Chem 1973;20:825–33.
- 3. JCGM 200: 2008 International vocabulary of metrology – basic and general concepts and associated terms (VIM). Geneva: International Organization for Standardization, 2008:104. (accessed May 5 2018).
- 4. White GH. Basics of estimating measurement uncertainty. Clin Biochem Rev 2008;29(Suppl 1):S53–60.
- 5. Barwick V. Evaluatig measurement uncertainity in clinical chemistry. UK National Measurement Systems: Report no: LGC/R/2010/17, 2012.
- 6. 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;53:833–5.
- 7. Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance. Fed Reg 2019;84:1536–67.
- 8. https://www.westgard.com/biodatabase1.htm (accessed 13 Nov 2019).
- 9. Bartlett WA, Braga F, Carobene A, Coskun A, Prusa R, FernandezCalle P, et al. A checklist for critical appraisal of studies of biological variation. Clin Chem Lab Med 2015;53:879–85.
- 10. Carobene A, Strollo M, Jonker N, Barla G, Bartlett WA, Sandberg S, et al. Sample collections from healthy volunteers for biological variation estimates’ update: a new project undertaken by the Working Group on Biological Variation established by the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med 2016;54:1599–608.
- 11. Carobene A, Røraas T, Sølvik UØ, Sylte MS, Sandberg S, Guerra E, et al. Biological variation estimates obtained from 91 healthy study participants for 9 enzymes in serum. Clin Chem 2017;63:1141–50.
- 12. Aarsand AK, Díaz-Garzón J, Fernandez-Calle P, Guerra E, Locatelli M, Bartlett WA. EuBIVAS: within- and between-subject biological variation data for electrolytes, lipids, urea, uric acid, total protein, total bilirubin, direct bilirubin, and glucose. Clin Chem 2018;64:1380–93.
- 13. EFLM database, https://biologicalvariation.eu/meta_calculations (accessed 13 Nov 2019).
- 14. ISO 15189. Medical laboratories – requirements for quality and competence. Geneva: ISO, 2012.
- 15. Cotlove E, Harris EK, Williams GZ. Biological and analytic components of variation in long-term studies of serum constituents in normal subjects. III. Physiological and medial implications. Clin Chem 1970;16:1028–32.
- 16. Fraser CG, Hyltoft Petersen P. Quality goals in external quality assessment are best based on biology. Scand J Clin Lab Invest 1993;53(Suppl 212):8–9.
- 17. Haeckel R, Wosniok W, Gurr E, Peil B. Permissible limits for uncertainty of measurement in laboratory medicine. Clin Chem Lab Med 2015;53:1161–71.
- 18. Türkiye Toplam Analitik Hata Genelgesi (2016/18) https://dosyamerkez.saglik.gov.tr/Eklenti/2581,genelge-201618izin-verilentoplam-hata-sinirlaripdf.pdf (accessed 13 Nov 2019).
- 19. Ricós C, Ramón F, Salas A, Buño A, Calafell R, Morancho J, et al. Minimum analytical quality specifications of interlaboratory comparisons: agreement among Spanish EQA organizers. Clin Chem Lab Med 2012;50:455–61.
- 20. Magnusson B, Naykki T, Hovind H, Krysell M. Handbook for calculation of measurement uncertainty in environmental laboratories, NordTest Report TR 537. NORDTEST, Finland, 2004.
- 21. CLIA Requirements for Analytical Quality, https://www.westgard. com/clia.htm (accessed 13 Nov 2019).
- 22. Jones GR, Sikaris K, Gill J. ‘Allowable Limits of Performance’ for External Quality Assurance Programs – an Approach to Application of the Stockholm Criteria by the RCPA Quality Assurance Programs. Clin Biochem Rev 2012;33:133–9.
- 23. Ozarda Y, Ichihara K, Aslan D, Aybek H, Ari Z, Taneli F, et al. A multicenter nationwide reference intervals study for common biochemical analytes in Turkey using Abbott analyzers. Clin Chem Lab Med 2014;52:1823–33.
- 24. https://www.dgkl.de/en/activities/workinggroups/entscheidungsgrenzen-richtwerte/#c699 (accessed 13 Nov 2019).
- 25. Panteghini M, Sandberg S. Defining analytical performance specifications 15 years after the Stockholm conference. Clin Chem Lab Med 2015;53:829–32.
- 26. Guide to the expression of uncertainty in measurement (GUM). Switzerland: JCGM, 2008:100.
- 27. Clinical and Laboratory Standards Institute. Expression of measurement uncertainty in laboratory medicine. Wayne, PA: CLSI, 2012.
- 28. Burnett D, Ceriotti F, Cooper G, Parvin C, Plebani M, Westgard J. Collective opinion paper on findings of the 2009 convocation of experts on quality control. Clin Chem Lab Med 2010;48:41– 52.
- 29. Theodorsson E, Magnusson B, Leito I. Bias in clinical chemistry. Bioanalysis 2014;6:2855–75.
- 30. Mercan F, Serdar MA, Senes M, Konukoglu D, İnal TC, Alatas O, et al. National External Quality Assessment follow-up: 2010– 2017 Turkish experience. Turk J Biochem 2019;44:1–8.
- 31. Sten Westgard. Comparing Verdicts from Different Goals, Models, and Specifications-Roche cobas 8000 c701, 2016. https:// www.westgard.com/goal-verdict-comparison1.htm (accessed 13 Nov 2019).
| APA | KELEŞ M (2020). Evaluation of the clinical chemistrytests analytical performance by usingdifferent models and specifications. , 11 - 18. 10.1515/tjb-2018-0250 |
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| IEEE | KELEŞ M "Evaluation of the clinical chemistrytests analytical performance by usingdifferent models and specifications." , ss.11 - 18, 2020. 10.1515/tjb-2018-0250 |
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| APA | KELEŞ M (2020). Evaluation of the clinical chemistrytests analytical performance by usingdifferent models and specifications. Türk Biyokimya Dergisi, 45(1), 11 - 18. 10.1515/tjb-2018-0250 |
| Chicago | KELEŞ Murat Evaluation of the clinical chemistrytests analytical performance by usingdifferent models and specifications. Türk Biyokimya Dergisi 45, no.1 (2020): 11 - 18. 10.1515/tjb-2018-0250 |
| MLA | KELEŞ Murat Evaluation of the clinical chemistrytests analytical performance by usingdifferent models and specifications. Türk Biyokimya Dergisi, vol.45, no.1, 2020, ss.11 - 18. 10.1515/tjb-2018-0250 |
| AMA | KELEŞ M Evaluation of the clinical chemistrytests analytical performance by usingdifferent models and specifications. Türk Biyokimya Dergisi. 2020; 45(1): 11 - 18. 10.1515/tjb-2018-0250 |
| Vancouver | KELEŞ M Evaluation of the clinical chemistrytests analytical performance by usingdifferent models and specifications. Türk Biyokimya Dergisi. 2020; 45(1): 11 - 18. 10.1515/tjb-2018-0250 |
| IEEE | KELEŞ M "Evaluation of the clinical chemistrytests analytical performance by usingdifferent models and specifications." Türk Biyokimya Dergisi, 45, ss.11 - 18, 2020. 10.1515/tjb-2018-0250 |
| ISNAD | KELEŞ, Murat. "Evaluation of the clinical chemistrytests analytical performance by usingdifferent models and specifications". Türk Biyokimya Dergisi 45/1 (2020), 11-18. https://doi.org/10.1515/tjb-2018-0250 |
