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

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.

IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C.

This paper is the eighth in a series dealing with reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C and the certification of reference preparations. Other parts deal with: Part 1. The concept of reference procedures for the measurement of catalytic activity concentrations of enzymes; Part 2. Reference procedure for the measurement of catalytic concentration of creatine kinase; Part 3. Reference procedure for the measurement of catalytic concentration of lactate dehydrogenase; Part 4. Reference procedure for the measurement of catalytic concentration of alanine aminotransferase Part 5. Reference procedure for the measurement of catalytic concentration of aspartate aminotransferase Part 6. Reference procedure for the measurement of catalytic concentration of gamma-glutamyltransferase; Part 7. Certification of four reference materials for the determination of enzymatic activity of gamma-glutamyltransferase, lactate dehydrogenase, alanine aminotransferase and creatine kinase at 37 degrees C. The procedure described here is deduced from the previously described 30 degrees C IFCC reference method. Differences are tabulated and commented on.

Procedimientos primarios de referencia de la IFCC para la medición de concentraciones de actividad catalítica de enzimas a 37 ºC: Parte 8. Procedimiento de referencia para la medición de la concentración catalítica de alfa-amilasa [alfa-Amilasa: 1,4-alfa-D-glucan 4-glucanohidrolasa (AMY), EC 3.2.1.1]

Este trabajo es el octavo de una serie dedicada a los procedimientos de referencia para la medición de las concentraciones de actividad catalítica de las enzimas a 37 ºC y a la certificación de las preparaciones de referencia. Otras partes se refieren a: Parte 1. El concepto de los procedimientos de referencia para la medición de las concentraciones de la actividad catalítica de las enzimas; Parte 2. Procedimiento de referencia para la medición de la concentración catalítica de creatina quinasa; Parte 3: Procedimiento de referencia para la medición de la concentración catalítica de lactato deshidrogenasa; Parte 4. Procedimiento de referencia para la medición de la concentración catalítica de alanin aminotransferasa; Parte 5. Procedimiento de referencia para la medición de la concentración catalítica de aspartato aminotransferasa; Parte 6. Procedimiento de referencia para la medición de la concentración catalítica de gamma-glutamiltransferasa; Parte 7. Certificación de cuatro materiales de referencia para la determinación de la actividad enzimática de gamma-glutamiltransferasa, lactato deshidrogenasa, alanin aminotransferasa y creatina quinasa a 37 ºC. El procedimiento que se describe aquí se deduce a partir del método de referencia de la IFCC a 30 ºC descrito previamente. Las diferencias se tabulan y comentan en Clin Chem Lab Med 2006; 44: 1146-55.