PMID- 22779064 OWN - NLM STAT- MEDLINE DCOM- 20121030 LR - 20240315 IS - 2234-3814 (Electronic) IS - 2234-3806 (Print) IS - 2234-3806 (Linking) VI - 32 IP - 4 DP - 2012 Jul TI - Trueness assessment for serum glucose measurement using commercial systems through the preparation of commutable reference materials. PG - 243-9 LID - 10.3343/alm.2012.32.4.243 [doi] AB - BACKGROUND: Commutable reference materials (RMs) are suitable for end-users for evaluating the metrological traceability of values obtained using routine measurement systems. We assessed the performance of 6 routine measurement systems with validated secondary RMs. METHODS: We tested the homogeneity, stability, and commutability of 5 minimally processed human serum pools according to the standard guidelines. The serum pools were assigned values as per the reference procedure of the United States Centers for Disease Control and were used to evaluate the trueness of results from 6 commercial measurement systems based on enzymatic methods: 3 glucose oxidase (GOD) and 3 hexokinase (HK) methods. RESULTS: The prepared RMs were validated to be sufficiently homogenous, stable, and commutable with the patient samples. Method bias varied for different systems: GOD01, -0.17 to 2.88%; GOD02, 1.66 to 4.58%; GOD03, -0.17 to 3.14%; HK01, -3.48 to -0.85%; HK02, -3.83 to -0.11%, and HK03, -1.82 to -0.27%. CONCLUSIONS: We observed that the prepared serum glucose RMs were qualified for trueness assessment. Most of the measurement systems met the minimal quality specifications. FAU - Xia, Changyu AU - Xia C AD - Department of Clinical Laboratory, Peking University First Hospital, Beijing, China. FAU - Liu, Ou AU - Liu O FAU - Wang, Lanzhen AU - Wang L FAU - Xu, Guobing AU - Xu G LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20120620 PL - Korea (South) TA - Ann Lab Med JT - Annals of laboratory medicine JID - 101571172 RN - 0 (Blood Glucose) RN - 0 (Reagent Kits, Diagnostic) RN - EC 1.1.3.4 (Glucose Oxidase) RN - EC 2.7.1.1 (Hexokinase) SB - IM MH - Blood Chemical Analysis/instrumentation/*standards MH - Blood Glucose/*analysis MH - Glucose Oxidase/metabolism MH - Hexokinase/metabolism MH - Humans MH - Reagent Kits, Diagnostic MH - Reference Standards MH - Regression Analysis PMC - PMC3384804 OTO - NOTNLM OT - Bias OT - Commercial system OT - Glucose OT - Reference material COIS- No potential conflicts of interest relevant to this article were reported. EDAT- 2012/07/11 06:00 MHDA- 2012/10/31 06:00 PMCR- 2012/07/01 CRDT- 2012/07/11 06:00 PHST- 2011/12/27 00:00 [received] PHST- 2012/03/30 00:00 [revised] PHST- 2012/05/18 00:00 [accepted] PHST- 2012/07/11 06:00 [entrez] PHST- 2012/07/11 06:00 [pubmed] PHST- 2012/10/31 06:00 [medline] PHST- 2012/07/01 00:00 [pmc-release] AID - 10.3343/alm.2012.32.4.243 [doi] PST - ppublish SO - Ann Lab Med. 2012 Jul;32(4):243-9. doi: 10.3343/alm.2012.32.4.243. Epub 2012 Jun 20.