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2018, Cilt 16, Sayı 2, Sayfa(lar) 117-126
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Allowable Total Error Criteria (TEa) Comparison Between Turkey and CLIA
Zeynep Altun1, Ayşegül Keleş2, Nilhan Nurlu Ayan3
1Ağrı Patnos Devlet Hastanesi, Klinik Biyokimya, Ağrı, Türkiye
2Ankara Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi, Klinik Biyokimya, Ankara, Türkiye
3İstanbul Gaziosmanpaşa Taksim Eğitim ve Araştırma Hastanesi, Klinik Biyokimya, İstanbul, Türkiye
Keywords: Allowable total error (TEa), sigmametric, third party control

Purpose: Allowable total error (TEa) is an analytical quality specification setting acceptable limits for a single test result. It is used for sigmametric evaluation of test performance and description of control rules and measurement numbers. Total error of a test (TE) should not exceed the TEa as well. In Turkey, TEa criteria for some of laboratory tests have been defined as well as in many countries and their routine application has been started in October 2016. In this study, we aimed to evaluate our laboratory analytical performance with CLIA criteria which are frequently used and with Turkey criteria and in that way to improve our current control procedures.

Materials and methods: We realized the study in Beckman Coulter AU5800 biochemistry analyzer which is in routine use in our laboratory, utilizing third party controls and Unity Real Time software, using control procedures created according to CLIA criteria for six months from February to August 2016.

Results: We found that the number of parameters with sigma values below 3 went from 7 to 3; above 6 from 9 to 14 and between 3 and 6 remainded the same when we applied Turkey criteria instead of CLIA’s. None of the TE values exceeded Turkey criteria including the two parameters whose sigmas were below 3, while 2 values were exceeding CLIA criteria.

Conclusion: The use of CLIA criteria with narrow acceptance intervals and the control procedures accordingly created to them provided us early detection of some errors. However, we think that Turkey criteria are more convenient for our laboratory conditions.


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