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CLSI H15

Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood, 3rd Edition

American National Standard. This document describes the principle, materials, and procedure for reference and standardized hemoglobin determinations. It includes specifications for secondary hemiglobincyanide (HiCN) standards.

This document is available in electronic format only.

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Details

Chairholder: Eugene L. Gottfried, MD and Charles F. Arkin, MD

Date of Publication: December 1, 2000

Order Code PDF: CLSI H15A3E
ISBN Number: 1-56238-425-2

Order Code Print: print not available

Edition: Third

Pages: 32

CLSI H15 Additional Details

If interested in ordering larger quantities of this document in print, please contact us here.

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 September 2016. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI H15 Abstract

CLSI document H15-A3, Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard—Third Edition, describes the measurement of blood hemoglobin using the hemiglobincyanide (HiCN) method, including composition of, and criteria for, the reagent and the calibration of photometers. The procedures described in H15 are required for whole blood calibration procedures for automated hematology analyzers; are necessary in the evaluation of instruments and alternative methods for the determination of hemoglobin concentration; and should be applied when patient red blood cell measurements are used for calibration and control of hematology analyzers. A separate section contains specifications for, and spectral characteristics of, HiCN solutions suitable for use as standards. The document enables users to achieve accurate hemoglobin concentration values for diagnostic or reference purposes. Producers of HiCN calibration standards can use the document as a guideline; users will have the information necessary to check for the content and purity of those materials.