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State of the art in trueness and interlaboratory harmonization for 10 analytes in general clinical chemistry. Arch Pathol Lab Med 2008 May;132(5):838-46

Date

05/10/2008

Pubmed ID

18466033

DOI

10.5858/2008-132-838-SOTAIT

Scopus ID

2-s2.0-43049106810 (requires institutional sign-in at Scopus site)   74 Citations

Abstract

CONTEXT: Harmonization and standardization of results among different clinical laboratories is necessary for clinical practice guidelines to be established.

OBJECTIVE: To evaluate the state of the art in measuring 10 routine chemistry analytes.

DESIGN: A specimen prepared as off-the-clot pooled sera and 4 conventionally prepared specimens were sent to participants in the College of American Pathologists Chemistry Survey. Analyte concentrations were assigned by reference measurement procedures.

PARTICIPANTS: Approximately 6000 clinical laboratories.

RESULTS: For glucose, iron, potassium, and uric acid, more than 87.5% of peer groups meet the desirable bias goals based on biologic variability criteria. The remaining 6 analytes had less than 52% of peer groups that met the desirable bias criteria.

CONCLUSIONS: Routine measurement procedures for some analytes had acceptable traceability to reference systems. Conventionally prepared proficiency testing specimens were not adequately commutable with a fresh frozen specimen to be used to evaluate trueness of methods compared with a reference measurement procedure.

Author List

Miller WG, Myers GL, Ashwood ER, Killeen AA, Wang E, Ehlers GW, Hassemer D, Lo SF, Seccombe D, Siekmann L, Thienpont LM, Toth A

Author

Stanley F. Lo PhD Professor in the Pathology department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Blood Chemical Analysis
Chemistry, Clinical
Humans
Laboratories
Pathology, Clinical
Quality Control
Reference Values
Reproducibility of Results
United States