PMID- 28643351
OWN - NLM
STAT- MEDLINE
DCOM- 20180611
LR  - 20210109
IS  - 1098-2825 (Electronic)
IS  - 0887-8013 (Print)
IS  - 0887-8013 (Linking)
VI  - 32
IP  - 3
DP  - 2018 Mar
TI  - Quality specifications of routine clinical chemistry methods based on sigma 
      metrics in performance evaluation.
LID - 10.1002/jcla.22284 [doi]
LID - e22284
AB  - INTRODUCTION: Sigma metrics were applied to evaluate the performance of 20 
      routine chemistry assays, and individual quality control criteria were 
      established based on the sigma values of different assays. METHODS: Precisions 
      were expressed as the average coefficient variations (CVs) of long-term two-level 
      chemistry controls. The biases of the 20 assays were obtained from the results of 
      trueness programs organized by National Center for Clinical Laboratories (NCCL, 
      China) in 2016. Four different allowable total error (TEa) targets were chosen 
      from biological variation (minimum, desirable, optimal), Clinical Laboratory 
      Improvements Amendments (CLIA, US), Analytical Quality Specification for Routine 
      Analytes in Clinical Chemistry (WS/T 403-2012, China) and the National 
      Cholesterol Education Program (NECP). RESULTS: The sigma values from different 
      TEa targets varied. The TEa targets for ALT, AMY, Ca, CHOL, CK, Crea, GGT, K, 
      LDH, Mg, Na, TG, TP, UA and Urea were chosen from WS/T 403-2012; the targets for 
      ALP, AST and GLU were chosen from CLIA; the target for K was chosen from 
      desirable biological variation; and the targets for HDL and LDL were chosen from 
      the NECP. Individual quality criteria were established based on different sigma 
      values. CONCLUSIONS: Sigma metrics are an optimal tool to evaluate the 
      performance of different assays. An assay with a high value could use a simple 
      internal quality control rule, while an assay with a low value should be 
      monitored strictly.
CI  - (c) 2017 Wiley Periodicals, Inc.
FAU - Xia, Jun
AU  - Xia J
AD  - Clinical Laboratory Center of Zhejiang Provincial People's Hospital, Hangzhou, 
      China.
AD  - People's Hospital of Hangzhou Medical college, Hangzhou, China.
FAU - Chen, Su-Feng
AU  - Chen SF
AD  - Clinical Laboratory Center of Zhejiang Provincial People's Hospital, Hangzhou, 
      China.
AD  - People's Hospital of Hangzhou Medical college, Hangzhou, China.
FAU - Xu, Fei
AU  - Xu F
AD  - Clinical Laboratory Center of Zhejiang Provincial People's Hospital, Hangzhou, 
      China.
AD  - People's Hospital of Hangzhou Medical college, Hangzhou, China.
FAU - Zhou, Yong-Lie
AU  - Zhou YL
AUID- ORCID: 0000-0003-2493-2155
AD  - Clinical Laboratory Center of Zhejiang Provincial People's Hospital, Hangzhou, 
      China.
AD  - People's Hospital of Hangzhou Medical college, Hangzhou, China.
LA  - eng
PT  - Journal Article
DEP - 20170623
PL  - United States
TA  - J Clin Lab Anal
JT  - Journal of clinical laboratory analysis
JID - 8801384
SB  - IM
MH  - Clinical Chemistry Tests/*standards
MH  - Humans
MH  - Models, Statistical
MH  - *Quality Control
MH  - Reproducibility of Results
PMC - PMC6816973
OTO - NOTNLM
OT  - allowable total error
OT  - quality control
OT  - sigma metrics
EDAT- 2017/06/24 06:00
MHDA- 2018/06/12 06:00
PMCR- 2017/06/23
CRDT- 2017/06/24 06:00
PHST- 2017/04/11 00:00 [received]
PHST- 2017/05/25 00:00 [accepted]
PHST- 2017/06/24 06:00 [pubmed]
PHST- 2018/06/12 06:00 [medline]
PHST- 2017/06/24 06:00 [entrez]
PHST- 2017/06/23 00:00 [pmc-release]
AID - JCLA22284 [pii]
AID - 10.1002/jcla.22284 [doi]
PST - ppublish
SO  - J Clin Lab Anal. 2018 Mar;32(3):e22284. doi: 10.1002/jcla.22284. Epub 2017 Jun 
      23.