PMID- 29683797
OWN - NLM
STAT- MEDLINE
DCOM- 20190517
LR  - 20210217
IS  - 1437-4331 (Electronic)
IS  - 1434-6621 (Linking)
VI  - 56
IP  - 9
DP  - 2018 Aug 28
TI  - Uncertainty evaluation in clinical chemistry, immunoassay, hematology and 
      coagulation analytes using only external quality assessment data.
PG  - 1447-1457
LID - 10.1515/cclm-2017-1199 [doi]
AB  - BACKGROUND: Measurement uncertainty (MU) is a parameter associated with the 
      result of a measurement that characterizes its dispersion. We report results for 
      estimating MU following the application of a top-down procedure using only 
      proficiency test data to establish uncertainty levels for various analytes. 
      METHODS: Data were obtained from 142 laboratories participating in the Beijing 
      Center for Clinical Laboratory (BCCL) proficiency testing/external quality 
      assessment (PT/EQA) schemes. The 24-month study included six selected PT 
      shipments to obtain estimates for 50th percentile (median) and 90th percentile 
      MUs and to compare those estimates to usual analytic goals. The number of 
      laboratory participants varied for each trial. The expanded uncertainty (U) was 
      calculated using a cover factor of k=2 for a confidence interval of 95%. All 
      reproducibility, method and laboratory biases came from the PT/EQA data. RESULTS: 
      The median U (k=2) ranged from 3.2% (plasma sodium, indirect ion selective 
      electrode) to 32.8% (triglycerides, free glycerol blanking) for clinical 
      chemistry analyte means from participants in the same method group. Immunoassay 
      analyte median U results ranged from 11.3% (CA125 tumor marker, Roche) to 33.8% 
      (prostate-specific antigen [PSA], Abbott). The range for median U was 3.5% (red 
      blood cell [RBC], Abx) to 30.3% (fibrinogen [FBG], other) for hematology and 
      coagulation analytes. The MUs for most analytes satisfied quality requirements. 
      CONCLUSIONS: The use of PT/EQA data, when available, provides an effective means 
      for estimating uncertainties associated with quantitative measurements. Thus, 
      medical laboratories can calculate their own MUs. Proficiency testing organizers 
      can provide participants with an additional MU estimate using only EQA data, 
      which may be updated at the end of each survey.
FAU - Qin, Yanyan
AU  - Qin Y
AD  - Department of Clinical Laboratory, Beijing Chao-Yang Hospital, Capital Medical 
      University, Beijing, P.R. China.
FAU - Zhou, Rui
AU  - Zhou R
AD  - Department of Clinical Laboratory, Beijing Chao-Yang Hospital, Capital Medical 
      University, Beijing, P.R. China.
FAU - Wang, Wei
AU  - Wang W
AD  - Department of Blood Transfusion, Beijing Ditan Hospital, Capital Medical 
      University, Beijing, P.R. China.
FAU - Yin, Hongyi
AU  - Yin H
AD  - Department of Clinical Laboratory, Beijing Chao-Yang Hospital, Capital Medical 
      University, Beijing, P.R. China.
FAU - Yang, Yanmin
AU  - Yang Y
AD  - Department of Clinical Laboratory, Fengtai Teaching Hospital of Capital Medical 
      University, Beijing, P.R. China.
FAU - Yue, Yuhong
AU  - Yue Y
AD  - Beijing Center for Clinical Laboratories, Beijing, P.R. China.
FAU - Tong, Qing
AU  - Tong Q
AD  - Beijing Center for Clinical Laboratories, Beijing, P.R. China.
FAU - Liu, Lu
AU  - Liu L
AD  - Beijing Center for Clinical Laboratories, Beijing, P.R. China.
FAU - Jin, Yali
AU  - Jin Y
AD  - Beijing Center for Clinical Laboratories, Beijing, P.R. China.
FAU - Shi, Yankun
AU  - Shi Y
AD  - Beijing Center for Clinical Laboratories, Beijing, P.R. China.
FAU - Zhang, Shunli
AU  - Zhang S
AD  - Department of Clinical Laboratory, Beijing Chao-Yang Hospital, Capital Medical 
      University, Beijing, P.R. China.
FAU - Zhang, Jianping
AU  - Zhang J
AD  - Department of Clinical Laboratory, Beijing Chao-Yang Hospital, Capital Medical 
      University, Beijing, P.R. China.
FAU - Zhang, Rui
AU  - Zhang R
AD  - Department of Clinical Laboratory, Beijing Chao-Yang Hospital, Capital Medical 
      University, Beijing, P.R. China.
FAU - Zuo, Chang
AU  - Zuo C
AD  - Department of Clinical Laboratory, Beijing Chao-Yang Hospital, Capital Medical 
      University, Beijing, P.R. China.
FAU - Jia, Tingting
AU  - Jia T
AD  - Department of Clinical Laboratory, Beijing Chao-Yang Hospital, Capital Medical 
      University, Beijing, P.R. China.
FAU - Wang, Ning
AU  - Wang N
AD  - Department of Clinical Laboratory, Beijing Chao-Yang Hospital, Capital Medical 
      University, Beijing, P.R. China.
FAU - Wang, Qingtao
AU  - Wang Q
AD  - Department of Clinical Laboratory, Beijing Chao-Yang Hospital, Capital Medical 
      University, Beijing, P.R. China.
AD  - Beijing Center for Clinical Laboratories, No.8 Gongti South Street, Chaoyang 
      District, Beijing, 100020, P.R. China, E-mail: wqt36@163.com.
LA  - eng
PT  - Journal Article
PL  - Germany
TA  - Clin Chem Lab Med
JT  - Clinical chemistry and laboratory medicine
JID - 9806306
SB  - IM
MH  - Blood Coagulation Tests/*standards
MH  - Clinical Chemistry Tests/*standards
MH  - Immunoassay/*standards
MH  - Laboratories/*standards
MH  - Quality Assurance, Health Care
MH  - Quality Control
MH  - Reproducibility of Results
MH  - *Uncertainty
OTO - NOTNLM
OT  - bias
OT  - measurement uncertainty
OT  - proficiency testing/external quality assessment
OT  - reproducibility
OT  - standardized
EDAT- 2018/04/24 06:00
MHDA- 2019/05/18 06:00
CRDT- 2018/04/24 06:00
PHST- 2017/12/22 00:00 [received]
PHST- 2018/03/13 00:00 [accepted]
PHST- 2018/04/24 06:00 [pubmed]
PHST- 2019/05/18 06:00 [medline]
PHST- 2018/04/24 06:00 [entrez]
AID - cclm-2017-1199 [pii]
AID - 10.1515/cclm-2017-1199 [doi]
PST - ppublish
SO  - Clin Chem Lab Med. 2018 Aug 28;56(9):1447-1457. doi: 10.1515/cclm-2017-1199.