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Evaluation of analytical performance specifications of routine clinical biochemistry tests with biological variation-based total allowable error (TEa) criteria [Int J Med Biochem ]
Int J Med Biochem . Ahead of Print: IJMB-39974 | DOI: 10.14744/ijmb.2018.39974

Evaluation of analytical performance specifications of routine clinical biochemistry tests with biological variation-based total allowable error (TEa) criteria

Orhan Çakmak1, Zeynep Altun2, Nilhan Nurlu Ayan3
1Department of Medical Biochemistry, Mardin State Hospital, Mardin, Turkey
2Department of Medical Biochemistry, Patnos State Hospital, Agrı, Turkey
3Department of Medical Biochemistry, Health Sciences University Gaziosmanpasa Taksim Education and Research Hospital, Istanbul, Turkey

INTRODUCTION: Total allowable error (TEa) is the analytical quality specification that determines the acceptable limits for a test result. In this study, our aim was to determine whether third party control data (CV%, bias% and TEa%) of 26 clinical biochemistry parameters collected over a period of 6 months would meet biological variation-based analytical quality specifications (minimum, desirable, optimum) and which biologic variation quality specification might be more appropriate for our laboratory use.
METHODS: The study was conducted during a 6 months, on tests with TEa values determined according to biological variation and using third party controls, Unity Real Time® software and Beckman Coulter AU 5800 clinical chemistry analyzer
RESULTS: The BV minimum specification is the easiest target to be performed by laboratories since it has the widest limits. It is also known that the BV already fulfills the other specifications (minimum and desirable) in tests where the optimum specification targets can be achieved and the test performance classifications of our work are made according to this information. The minimum specification is caught only in Level 2 control serum total cholesterol test, The optimum specification with the narrowest limits within the BV criteria and the most difficult to achieve was met in 9 tests (ALT, D.Bil, T.Bil, CK, GGT, Fe, Lip, Tg, U.A) for both control levels. Outside of these tests, in general, the desirable specification that each laboratory is aiming to fulfill is met.
DISCUSSION AND CONCLUSION: It is very valuable to set the boundaries of quality specifications targeted for analytical performance based on BV. Because these values are determined by the intra-individual and inter-individual variability of the test and thus define a test-specific target. In addition to defining the TEa for each specification of BV, the definition of bias and CV boundaries can give a more objective idea of the source of error.

Keywords: analytic performance, biologic variation, total allowable error



Corresponding Author: Nilhan Nurlu Ayan, Türkiye
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