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2018 ; 28
(2
): 020708
Nephropedia Template TP
gab.com Text
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English Wikipedia
Sigma metrics for assessing the analytical quality of clinical chemistry assays:
a comparison of two approaches: Electronic supplementary material available
online for this article
#MMPMID30022883
Guo X
; Zhang T
; Gao X
; Li P
; You T
; Wu Q
; Wu J
; Zhao F
; Xia L
; Xu E
; Qiu L
; Cheng X
Biochem Med (Zagreb)
2018[Jun]; 28
(2
): 020708
PMID30022883
show ga
INTRODUCTION: Two approaches were compared for the calculation of coefficient of
variation (CV) and bias, and their effect on sigma calculation, when different
allowable total error (TEa) values were used to determine the optimal method for
Six Sigma quality management in the clinical laboratory. MATERIALS AND METHODS:
Sigma metrics for routine clinical chemistry tests using three systems (Beckman
AU5800, Roche C8000, Siemens Dimension) were determined in June 2017 in the
laboratory of Peking Union Medical College Hospital. Imprecision (CV%) and bias
(bias%) were calculated for ten routine clinical chemistry tests using a
proficiency testing (PT)- or an internal quality control (IQC)-based approach.
Allowable total error from the Clinical Laboratory Improvement Amendments of 1988
and the Chinese Ministry of Health Clinical Laboratory Center Industry Standard
(WS/T403-2012) were used with the formula: Sigma = (TEa - bias) / CV to calculate
the Sigma metrics (?(CLIA), ?(WS/T)) for each assay for comparative analysis.
RESULTS: For the PT-based approach, eight assays on the Beckman AU5800 system,
seven assays on the Roche C8000 system and six assays on the Siemens Dimension
system showed ?(CLIA) > 3. For the IQC-based approach, ten, nine and seven
assays, respectively, showed ?(CLIA) > 3. Some differences in ? were therefore
observed between the two calculation methods and the different TEa values.
CONCLUSIONS: Both methods of calculating ? can be used for Six Sigma quality
management. In practice, laboratories should evaluate Sigma multiple times when
optimizing a quality control schedule.