PMID- 34606652 OWN - NLM STAT- MEDLINE DCOM- 20220222 LR - 20220222 IS - 1098-2825 (Electronic) IS - 0887-8013 (Print) IS - 0887-8013 (Linking) VI - 35 IP - 11 DP - 2021 Nov TI - Application of Sigma metrics in the quality control strategies of immunology and protein analytes. PG - e24041 LID - 10.1002/jcla.24041 [doi] LID - e24041 AB - BACKGROUND: Six Sigma (6sigma) is an efficient laboratory management method. We aimed to analyze the performance of immunology and protein analytes in terms of Six Sigma. METHODS: Assays were evaluated for these 10 immunology and protein analytes: Immunoglobulin G (IgG), Immunoglobulin A (IgA), Immunoglobulin M (IgM), Complement 3 (C3), Complement 4 (C4), Prealbumin (PA), Rheumatoid factor (RF), Anti streptolysin O (ASO), C-reactive protein (CRP), and Cystatin C (Cys C). The Sigma values were evaluated based on bias, four different allowable total error (TEa) and coefficient of variation (CV) at QC materials levels 1 and 2 in 2020. Sigma Method Decision Charts were established. Improvement measures of analytes with poor performance were recommended according to the quality goal index (QGI), and appropriate quality control rules were given according to the Sigma values. RESULTS: While using the TEa(NCCL) , 90% analytes had a world-class performance with sigma>6, Cys C showed marginal performance with sigma<4. While using minimum, desirable, and optimal biological variation of TEa, only three (IgG, IgM, and CRP), one (CRP), and one (CRP) analytes reached 6sigma level, respectively. Based on sigma(NCCL) that is calculated from TEa(NCCL) , Sigma Method Decision Charts were constructed. For Cys C, five multi-rules (1(3s) /2(2s) /R(4s) /4(1s) /6(X) , N = 6, R = 1, Batch length: 45) were adopted for QC management. The remaining analytes required only one QC rule (1(3s) , N = 2, R = 1, Batch length: 1000). Cys C need to improve precision (QGI = 0.12). CONCLUSIONS: The laboratories should choose appropriate TEa goals and make judicious use of Sigma metrics as a quality improvement tool. CI - (c) 2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC. FAU - Luo, Yanfen AU - Luo Y AD - Department of Medicine Laboratory, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Department of Medicine Laboratory, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. FAU - Yan, Xingxing AU - Yan X AD - Department of Medicine Laboratory, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Department of Medicine Laboratory, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. FAU - Xiao, Qian AU - Xiao Q AD - Department of Medicine Laboratory, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Department of Medicine Laboratory, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. FAU - Long, Yifei AU - Long Y AD - Department of Medicine Laboratory, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Department of Medicine Laboratory, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. FAU - Pu, Jieying AU - Pu J AD - Department of Medicine Laboratory, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Department of Medicine Laboratory, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. FAU - Li, Qiwei AU - Li Q AD - Department of Medicine Laboratory, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Department of Medicine Laboratory, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. FAU - Cai, Yimei AU - Cai Y AD - Department of Medicine Laboratory, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Department of Medicine Laboratory, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. FAU - Chen, Yushun AU - Chen Y AD - Department of Medicine Laboratory, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Department of Medicine Laboratory, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. FAU - Zhang, Hongyuan AU - Zhang H AD - Department of Medicine Laboratory, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Department of Medicine Laboratory, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. FAU - Chen, Cha AU - Chen C AD - Department of Medicine Laboratory, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Department of Medicine Laboratory, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. FAU - Ou, Songbang AU - Ou S AUID- ORCID: 0000-0001-6817-0290 AD - Reproductive center, Department of Obstetrics and Gynecology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. LA - eng PT - Journal Article DEP - 20211004 PL - United States TA - J Clin Lab Anal JT - Journal of clinical laboratory analysis JID - 8801384 RN - 0 (Antibodies) RN - 0 (Proteins) SB - IM MH - Antibodies/*analysis MH - Clinical Chemistry Tests/*standards MH - Humans MH - Proteins/*analysis MH - *Quality Control MH - *Total Quality Management PMC - PMC8605144 OTO - NOTNLM OT - Sigma Method Decision Charts OT - Sigma metrics OT - allowable total error OT - immunology and protein analytes OT - quality goal index COIS- None declared. EDAT- 2021/10/05 06:00 MHDA- 2022/02/23 06:00 PMCR- 2021/10/04 CRDT- 2021/10/04 17:35 PHST- 2021/09/22 00:00 [revised] PHST- 2021/07/13 00:00 [received] PHST- 2021/09/23 00:00 [accepted] PHST- 2021/10/05 06:00 [pubmed] PHST- 2022/02/23 06:00 [medline] PHST- 2021/10/04 17:35 [entrez] PHST- 2021/10/04 00:00 [pmc-release] AID - JCLA24041 [pii] AID - 10.1002/jcla.24041 [doi] PST - ppublish SO - J Clin Lab Anal. 2021 Nov;35(11):e24041. doi: 10.1002/jcla.24041. Epub 2021 Oct 4.