Journal of Turkish Clinical Biochemistry

The official publication of Turkish Society of Clinical Biochemistry

Diamond OA
No APCs
First Decision
30 Days
Indexed In
TR Dizin
Original Research
August 01, 2021
JTCB. 2021 Aug 1; 19 (2) : 099-107

Sigma Values According To Different %TEa Standards and Evaluation of the Analytical Phase

1 Ufuk Üniversitesi Tıp Fakültesi, Tıbbi Biyokimya Anabilim Dalı, Ankara, Türkiye

Abstract

Objectives: The aim of the study was to evaluate the analytical performance of the tests by calculating sigma values of some tests and to ensure that corrective actions were taken for the tests by presenting the differences between the sigma values calculated following different allowable total error (%TEa) standards.

Material and Methods: The present study has been carried out by using the data of internal quality control (IQC) and external quality control (EQC) studied between the dates 01/01/2020 and 03/31/2020. The evaluated tests were in 4 panels [Biochemistry (10 tests), Hormone-tumor markers (6 tests), Hemogram (5 tests), Coagulation (2 tests)].

Results: Significant differences were observed between the sigma values calculated according to the %TEa standards determined by different regulatory organizations.When the sigma values calculated following CLIA 2019 %TEa standard of the two-level IQC data in a total of 23 tests, present in 4 test panels, have been evaluated by considering Westgard's sigma rules; it has been observed that 8 IQC results should be evaluated by 13s, 8 IQC results by 13s/22s/R4s/41smultiple rules and 30 IQC results by 13s/22s/R4s/41s/8xmultiple rules.

Conclusion: In the quality management and evaluation of the tests performed in the laboratory, while determining the tests that require improvement studies and determining by which rules the improvement studies will be carried out, the ratio of %TEa of the regulatory organization selected to calculate the sigma values gains importance.

Citation

Erçin, Uğur. 2021. “Sigma Values According To Different %TEa Standards and Evaluation of the Analytical Phase”. Journal of Turkish Clinical Biochemistry 19 (2):099-107. https://turkclinbiochem.org/index.php/pub/article/view/392.

Publish with JTCB

Diamond Open Access

Fully Diamond OA with no APCs and no submission fees. Your research is freely available to readers worldwide from the day it publishes.

30-Day First Decision

Double-blind peer review from an active editorial team returns a first decision in about 30 days, keeping your manuscript moving.

Global Platform

Backed by the Turkish Society of Clinical Biochemistry, JTCB welcomes submissions from researchers worldwide and reaches an international laboratory audience.

Focused Laboratory Scope

Method validation, analyzer comparisons, reference intervals, quality indicators, preanalytical studies, and instructive clinical case reports.

Credible and Discoverable

All manuscripts publish in English and follow ICMJE and COPE guidelines, with Crossref DOIs and TR Dizin indexing ensuring global discoverability.