engleski

Analytical performance of tumor markers on UniCel DxI 600 using Sigma metrics

The Sigma concept of a tolerance limit provides guidance for defining intended medical use in the form of an allowable total error. Performance is characterized on a sigma scale. In terms of Sigma, if a method has a value less than three is considered to be unreliable and should not be used in routine laboratory practice. The aim of this study was to assess the performance of automated immunodiagnostic chemiluminescence system UniCel DxI 600 (Beckman-Coulter, Tokyo, Japan) for qualitative detection of tumor markers. Analytical performance for CA125 and CA19-9 is world class. On the other hand, CA15- 3 and PSA analytical performance is poor or even unacceptable. Using graphic tool it becomes apparent that bias is the main problem with CA15- 3 and PSA performance. With lower bias CA15-3 assay performance might even reach Six Sigma zone. Therefore, it is necessary to use the same method for individual patient. In that case, even these two methods became of excellent quality

analytical performance ; tumor markers ; sigma metrics

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