Total PSA ve serbest PSA testlerinin analitik performansının 6-sigma yöntemi ile değerlendirilmesi

Amaç: Sigma metrik yöntem, laboratuvarların analitik performansını değerlendirmede ve karşılaştırmada kullanılan bir kalite ölçüm yöntemidir. 6 sigma yöntemi ile klinik analitik faz değerlendirilebilir ve iç kalite kontrol (İKK) stratejisi ve sıklığı planlanabilir. Bu çalışmada tümör belirteçleri olan total PSA ve serbest PSA testlerinin sigma değerlerinin hesaplanarak analitik performanslarının değerlendirilmesi amaçlandı. Yöntem: Her iki test için de ardışık 3 aylık iç kalite kontrol sonuçları değerlendirilerek sigma seviyeleri hesaplandı. Bias ve varyasyon katsayısı (CV) hesaplandı. Toplam izin verilebilir hata (TEa) değeri için biyolojik varyasyon veritabanları kullanıldı. Hesaplanan sigma değerleri sırasıyla şöyle değerlendirildi: “>5”, “4-5”, “3-4” ve “5 ve 4-5, serbest PSA için ise her iki seviyede

The evaluation of analytical performance of Total PSA and Free PSA tests by using 6-sigma method

Objective: Sigma Metrics Methodology is a quality measurement method in order to evaluate and compare the analytical performance of laboratories. Six Sigma can be used as a clinical analytical phase assessment methodology to form an internal quality control (IQC) strategy and plan its frequency. In this study, we aimed to evaluate the analytical performance of the tumor markers total and free prostate specific antigen (PSA) by calculating process sigma values. Methods: Sigma levels for both tests were analyzed by using IQC values retrieved from laboratory information system for consecutive 3 months. Bias and coefficient of variation (CV) were calculated. Biological variation databases were used for Total Allowable Error (TEa). The calculated sigma values were classified as follows: “>5”, “4-5”, “3-4” and “ 5 and 4-5 for total PSA,while those for free PSA were

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1. Nar R, Emekli DI. The evaluation of analytical performance of immunoassay tests by using sixsigma method. J Med Biochem, 2017;36(4):301-8.
2. Mao X, Shao J, Zhang B, Wang Y. Evaluating analytical quality in clinical biochemistry laboratory using Six Sigma. Biochem Med, 2018;28(2):020904.
3. Nanda SK, Ray L. Quantitative application of sigma metrics in medical biochemistry. Journal of clinical and diagnostic research : JCDR. 2013;7(12):2689- 91.
4. Zaninotto M, Plebani M. Understanding and managing interferences in clinical laboratory assays: the role of laboratory professionals. Clin Chem Lab Med, 2019 doi: 10.1515/cclm-2019-0898.
5. Zhou B, Wu Y, He H, Li C, Tan L, Cao Y. Practical application of Six Sigma management in analytical biochemistry processes in clinical settings. J Clin Lab Anal, 2019 Nov 27:e23126. doi: 10.1002/ jcla.23126.
6. Harr KE, Flatland B, Nabity M, Freeman KP. ASVCP guidelines: allowable total error guidelines for biochemistry. Vet Clin Pathol, 2013, 42(4):424-36.
7. Ercan Karadağ M, Kirmit A. Tiroid Fonksiyon testlerinin analitik performansının değerlendirilmesinde; 6 sigma metodolojisi. Harran Univ Vet Fak Derg, (Journal of Harran University Medical Faculty) 2019;16(3):505-8.
8. Westgard JO, Klee GG. Quality management. In: Burtis CA, Ashwood ER, Bruns DE, eds. Tietz textbook of clinical chemistry and molecular diagnostics St. Louis, MO: Elsevier Saunders, 2006: 485–529.
9. Schoenmakers CH, Naus AJ, Vermeer HJ, van Loon D, Steen G. Practical application of Sigma Metrics QC procedures in clinical chemistry. Clin Chem Lab Med, 2011; 49(11): 1837–43.
10. Vezyraki P, Vlachaki A, Baltogiannis D, Batistatou A, Tsampalas S, Simos YV et al. Impact of total PSA and percent free PSA in the differentiation of prostate disease: a retrospective comparative study implicating neoplastic and non-neoplastic entities. J BUON, Sep-Oct 2019;24(5):2107-13.
11. Lamy PJ, Brouillet JP, Bermont L, Fouillet G, Loric S. Relevance of total PSA and free PSA prescriptions. Ann Biol Clin (Paris), 2018 Dec 1;76(6):659-63.
12. Ricós C, Alvarez V, Cava F, Garcia-Lario J, Hernandez A, Jimenez C, et al. Current databases on biological variation: pros, cons and progress. Scand J Clin Lab Invest, 1999;59(7):491-500.
13. Allowable Limits of Performance: Programs, Analytes and Allowable Limits of Performance. Royal College of Pathologists of Australasia, Quality Assurance Programs; c2012 [updated 2014] Available from: http://www.rcpaqap.com.au/ docs/2014/chempath/ALP.pdf. Accessed February 27, 2018.
14. Prcic A, Begic E, Hiros M. Actual Contribution of Free to Total PSA Ratio in Prostate Diseases Differentiation. Med Arch, 2016 Jul 27; 70(4): 288– 92.
15. Catalona WJ, Smith DS, Wolfert RL, Wang TJ, Rittenhouse HG, Ratliff TL et al. Evaluation of percentage of free serum prostate-specific antigen to improve specificity of prostate cancer screening. JAMA, 1995; 274: 1214-20.
16. Petrides V, Schneider S. Using Sigma metrics to establish analytical product performance requirements and optimize analytical performance of an in vitro diagnostic assay using a theoretical total PSA assay as an example. Biochem Med (Zagreb), 2018 Jun 15;28(2):020903.