Within the context of good clinical laboratory practices evaluation of measurement uncertainty of TSH and PSA parameters [İyi klinik laboratuvar uygulamaları kapsamında TSH ve PSA parametrelerinin ölçüm belirsizliğinin Değerlendirilmesi]
Turkmen S.,Tbbi Biyokimya Laboratuvar |
Yldrmak S.T.,Tbbi Biyokimya Laboratuvar |
Yekrek M.,Tbbi Biyokimya Laboratuvar |
Cimen B.,Tbbi Biyokimya Laboratuvar |
And 4 more authors.
Turkish Journal of Biochemistry | Year: 2014
Objective: Accreditation practices that are considered in the scope of quality in laboratories are rapidly becoming widespread. Measurement uncertainty (u) provides information about the quality and reliability of test results. Among biochemical tests prostate specific antigen (PSA) and thyroid stimulating hormone (TSH) with their low and high reference interval limits have prognostic value for treatment. The aim of this study was to determine the measurement uncertainties of these two analytes by illustrating the reliability of lower and upper reference limits and the differences other than biological changes for treatment follow up. Methods: Calibrator and calibration drift uncertainty, reagent certificate uncertainty, and reproducibility uncertainty were calculated as components of uncertainty. Standard combined uncertainty relative to mean (uc/C analysis) was found by taking square roots of squares of uncertainty components relative to mean. The enlarged uncertainty (U=k×uc) was obtained by multiplying the standard combined uncertainty (uc) with an appropriate k factor (scope factor). Results: The obtained results of measurement uncertainty were lower than limits of total allowable error. Conclusion: The measurement uncertainty results of total PSA, free PSA and TSH were found within the limits of biological variation in accordance with good clinical laboratory practices under GUM (Guide to the Expression of Uncertanty in Measurement) and EUROCAM (A Focus for Analytical Chemistry in Europe). © TurkJBiochem.com.