CLSI C39

A Designated Comparison Method for the Measurement of Ionized Calcium in Serum, 1st Edition

This document describes a designated comparison method to standardize the ionized calcium measurements made by ion-selective electrode (ISE) potentiometry.

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Chairholder: Paul D'Orazio, PhD and Gary A. Graham, PhD

Date of Publication: April 1, 2000

Order Code PDF: CLSI C39AE
ISBN Number: 1-56238-398-1

Order Code Print: print not available

Edition: First

Pages: 66

CLSI C39 Additional Details

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of April 2016. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI C39 Abstract

CLSI document C39-A A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard provides a candidate designated comparison method to standardize the measurement of ionized calcium made by ion-selective electrode (ISE) potentiometry. This system can be used to assign ionized calcium concentrations to a commercially available, serum-based material to improve the traceability and transferability of results for the measurement of ionized calcium in the clinical laboratory. This standard addresses the principle of the test, the assignment of ionized calcium concentrations to NIST Standard Reference Material 956a, the materials and methods used, and the results and conclusions of an interlaboratory study to assign the ionized calcium concentrations.