PMID- 31386228
OWN - NLM
STAT- MEDLINE
DCOM- 20200416
LR  - 20210110
IS  - 1098-2825 (Electronic)
IS  - 0887-8013 (Print)
IS  - 0887-8013 (Linking)
VI  - 33
IP  - 9
DP  - 2019 Nov
TI  - Comparative analysis of calculating sigma metrics by a trueness verification 
      proficiency testing-based approach and an internal quality control data 
      inter-laboratory comparison-based approach.
PG  - e22989
LID - 10.1002/jcla.22989 [doi]
LID - e22989
AB  - INTRODUCTION: Two methods were compared for evaluating the sigma metrics of 
      clinical biochemistry tests using two different allowable total error (TEa) 
      specifications. MATERIALS AND METHODS: The imprecision (CV%) and bias (bias%) of 
      19 clinical biochemistry analytes were calculated using a trueness verification 
      proficiency testing (TPT)-based approach and an internal quality control data 
      inter-laboratory comparison (IQC)-based approach, respectively. Two sources of 
      total allowable error (TEa), the Clinical Laboratory Improvement Amendments of 
      1988 (CLIA '88) and the People's Republic of China Health Industry Standard (WS/T 
      403-2012), were used to calculate the sigma metrics (sigma(CLIA,) sigma(WS/T) ). Sigma 
      metrics were calculated to provide a single value for assessing the quality of 
      each test based on a single concentration level. RESULTS: For both approaches, 
      sigma(CLIA)  > sigma(WS/T) in 18 out of 19 assays. For the TPT-based approach, 16 assays 
      showed sigma(CLIA)  > 3, and 12 assays showed sigma(WS/T)  > 3. For the IQC-based 
      approach, 19 and 16 assays showed sigma(CLIA)  > 3 and sigma(WS/T)  > 3, respectively. 
      CONCLUSIONS: Both methods can be used as references for calculating sigma metrics 
      and designing QC schedules in clinical laboratories. Sigma metrics should be 
      evaluated comprehensively by different approaches.
CI  - (c) 2019 The Authors. Journal of Clinical Laboratory Analysis published by Wiley 
      Periodicals, Inc.
FAU - Li, Runqing
AU  - Li R
AUID- ORCID: 0000-0003-3139-2871
AD  - Department of Laboratory Medicine, Beijing Tsinghua Changgung Hospital, School of 
      Clinical Medicine, Tsinghua University, Beijing, China.
FAU - Wang, Tengjiao
AU  - Wang T
AD  - Department of Laboratory Medicine, Beijing Tsinghua Changgung Hospital, School of 
      Clinical Medicine, Tsinghua University, Beijing, China.
FAU - Gong, Lijun
AU  - Gong L
AD  - Department of Laboratory Medicine, Beijing Tsinghua Changgung Hospital, School of 
      Clinical Medicine, Tsinghua University, Beijing, China.
FAU - Peng, Peng
AU  - Peng P
AD  - Department of Laboratory Medicine, Beijing Tsinghua Changgung Hospital, School of 
      Clinical Medicine, Tsinghua University, Beijing, China.
FAU - Yang, Song
AU  - Yang S
AD  - Department of Laboratory Medicine, Beijing Tsinghua Changgung Hospital, School of 
      Clinical Medicine, Tsinghua University, Beijing, China.
FAU - Zhao, Haibin
AU  - Zhao H
AD  - Department of Laboratory Medicine, Beijing Tsinghua Changgung Hospital, School of 
      Clinical Medicine, Tsinghua University, Beijing, China.
FAU - Xiong, Pan
AU  - Xiong P
AD  - Department of Laboratory Medicine, Beijing Tsinghua Changgung Hospital, School of 
      Clinical Medicine, Tsinghua University, Beijing, China.
LA  - eng
GR  - PG2018013/The Incubation Program Project of Beijing Municipal Administration of 
      Hospitals of China/
PT  - Comparative Study
PT  - Journal Article
DEP - 20190806
PL  - United States
TA  - J Clin Lab Anal
JT  - Journal of clinical laboratory analysis
JID - 8801384
SB  - IM
MH  - Biological Assay
MH  - Humans
MH  - Laboratory Proficiency Testing/*standards
MH  - Quality Control
MH  - Reproducibility of Results
MH  - *Statistics as Topic
PMC - PMC6868403
OTO - NOTNLM
OT  - allowable total error
OT  - internal quality control
OT  - proficiency testing
OT  - sigma metrics
COIS- None declared.
EDAT- 2019/08/07 06:00
MHDA- 2020/04/17 06:00
PMCR- 2019/08/06
CRDT- 2019/08/07 06:00
PHST- 2019/05/19 00:00 [received]
PHST- 2019/07/02 00:00 [revised]
PHST- 2019/07/11 00:00 [accepted]
PHST- 2019/08/07 06:00 [pubmed]
PHST- 2020/04/17 06:00 [medline]
PHST- 2019/08/07 06:00 [entrez]
PHST- 2019/08/06 00:00 [pmc-release]
AID - JCLA22989 [pii]
AID - 10.1002/jcla.22989 [doi]
PST - ppublish
SO  - J Clin Lab Anal. 2019 Nov;33(9):e22989. doi: 10.1002/jcla.22989. Epub 2019 Aug 6.