State of the art in trueness and interlaboratory harmonization for 10 analytes in general clinical chemistry.
BACKGROUND
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.


METHODS
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.


METHODS
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.
Miller
W Greg
WG
Department of Pathology, Virginia Commonwealth University, PO Box 980286, Richmond, VA 23298-0286, USA. gmiller@vcu.edu
Myers
Gary L
GL
Ashwood
Edward R
ER
Killeen
Anthony A
AA
Wang
Edward
E
Ehlers
Glenn W
GW
Hassemer
David
D
Lo
Stanley F
SF
Seccombe
David
D
Siekmann
Lothar
L
Thienpont
Linda M
LM
Toth
Alan
A
D001774:Blood Chemical Analysis / Q000592:standards* / Q000706:statistics & numerical data; D002624:Chemistry, Clinical / Q000592:standards* / Q000706:statistics & numerical data; D006801:Humans; D007753:Laboratories / Q000592:standards* / Q000706:statistics & numerical data; D010338:Pathology, Clinical / Q000592:standards* / Q000706:statistics & numerical data; D011786:Quality Control; D012016:Reference Values; D015203:Reproducibility of Results; D014481:United States