PMID- 30280434
OWN - NLM
STAT- MEDLINE
DCOM- 20190311
LR  - 20210109
IS  - 1098-2825 (Electronic)
IS  - 0887-8013 (Print)
IS  - 0887-8013 (Linking)
VI  - 33
IP  - 2
DP  - 2019 Feb
TI  - Application of Six Sigma for evaluating the analytical quality of tumor marker 
      assays.
PG  - e22682
LID - 10.1002/jcla.22682 [doi]
LID - e22682
AB  - CONTEXT: The results of detection assays for the same specimen are usually quite 
      different in different laboratories or when tested with different detection 
      systems. OBJECTIVE: This study was designed to investigate the value of applying 
      sigma metrics derived from different standards for allowable total error (TEa) in 
      evaluating the analytical quality of tumor marker assays. METHODS: Assays were 
      evaluated for these six tumor markers: total prostate-specific antigen (tPSA), 
      carcinoembryonic antigen (CEA), alpha-fetoprotein (AFP), carbohydrate antigen 199 
      (CA199), carbohydrate antigen 125 (CA125), and carbohydrate antigen 153 (CA153). 
      Sigma values were calculated for two concentrations of quality control products 
      to assess differences in quality of tumor marker assays. Improvement measures 
      were recommended according to the quality goal index, and appropriate quality 
      control rules were selected according to the sigma value. RESULTS: The sigma 
      value was highest using the higher biological variation-derived "appropriate" TEa 
      standard: it was sigma >/=6 or higher in 16.7% of tumor markers. Sigma was below 6 
      for all tumor markers using the other three TEa. CEA, AFP, CA199, CA125, and 
      CA153 required improved precision. The marker tPSA required improve precision and 
      accuracy. According to sigma values by using China's external quality assessment 
      standards, CEA, AFP, CA125, and CA153 require 1(3s) /2(2s) /R(4s) /4(1s) 
      multirules for internal quality control, CA199 requires use of 1(3s) /2(2s) 
      /R(4s) /4(1s) /8(x) multirules, and tPSA requires maximum quality control rules. 
      CONCLUSION: Six Sigma is useful for evaluating performance of tumor markers 
      assays and has important application value in the quality control of these 
      assays.
CI  - (c) 2018 The Authors Journal of Clinical Laboratory Analysis Published by Wiley 
      Periodicals, Inc.
FAU - Liu, Qian
AU  - Liu Q
AD  - Department of Medicine Laboratory, The Second People's Hospital of Lianyungang, 
      Lianyungang, China.
FAU - Fu, Mei
AU  - Fu M
AD  - Department of Medicine Laboratory, The Second People's Hospital of Lianyungang, 
      Lianyungang, China.
FAU - Yang, Fumeng
AU  - Yang F
AD  - Department of Medicine Laboratory, The Second People's Hospital of Lianyungang, 
      Lianyungang, China.
FAU - Liang, Wei
AU  - Liang W
AD  - Department of Medicine Laboratory, The Second People's Hospital of Lianyungang, 
      Lianyungang, China.
FAU - Yang, Chuanxi
AU  - Yang C
AUID- ORCID: 0000-0002-6970-1214
AD  - Department of Cardiology, Jiangsu Province Hospital, Medical School of Southeast 
      University, Nanjing, China.
FAU - Zhu, Wenjun
AU  - Zhu W
AD  - Department of Medicine Laboratory, The Second People's Hospital of Lianyungang, 
      Lianyungang, China.
FAU - Ma, Liming
AU  - Ma L
AD  - Department of Medicine Laboratory, The Second People's Hospital of Lianyungang, 
      Lianyungang, China.
FAU - Zhao, Changxin
AU  - Zhao C
AD  - Department of Medicine Laboratory, The Second People's Hospital of Lianyungang, 
      Lianyungang, China.
LA  - eng
GR  - TQ201709/fund in the growth of young talents in Lianyungang Second People's 
      Hospital/
PT  - Journal Article
DEP - 20181002
PL  - United States
TA  - J Clin Lab Anal
JT  - Journal of clinical laboratory analysis
JID - 8801384
RN  - 0 (Biomarkers, Tumor)
RN  - 0 (CA-125 Antigen)
RN  - 0 (Carcinoembryonic Antigen)
RN  - 0 (alpha-Fetoproteins)
SB  - IM
MH  - Biomarkers, Tumor/*analysis/*standards
MH  - CA-125 Antigen/analysis
MH  - Carcinoembryonic Antigen/analysis
MH  - China
MH  - Humans
MH  - Reproducibility of Results
MH  - Total Quality Management/*methods/*standards
MH  - alpha-Fetoproteins/analysis
PMC - PMC6585744
OTO - NOTNLM
OT  - allowable total error
OT  - quality control rules
OT  - sigma metrics
OT  - tumor marker
EDAT- 2018/10/04 06:00
MHDA- 2019/03/12 06:00
PMCR- 2018/10/02
CRDT- 2018/10/04 06:00
PHST- 2018/03/15 00:00 [received]
PHST- 2018/08/29 00:00 [revised]
PHST- 2018/08/31 00:00 [accepted]
PHST- 2018/10/04 06:00 [pubmed]
PHST- 2019/03/12 06:00 [medline]
PHST- 2018/10/04 06:00 [entrez]
PHST- 2018/10/02 00:00 [pmc-release]
AID - JCLA22682 [pii]
AID - 10.1002/jcla.22682 [doi]
PST - ppublish
SO  - J Clin Lab Anal. 2019 Feb;33(2):e22682. doi: 10.1002/jcla.22682. Epub 2018 Oct 2.