CLSI H15
Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood
This standard provides essential guidelines for accurately measuring blood hemoglobin using the hemiglobincyanide (HiCN) method. It details calibration procedures for hematology analyzers, specifications for HiCN standards, and quality criteria to ensure precise and reliable hemoglobin results.
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{{FormatPrice(nonMemberPrice)}} List PriceCLSI 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.
Part I of this standard describes the determination of hemoglobin concentration in human blood by the HiCN (cyanmethemoglobin) method. Accurate determination of hemoglobin concentration is:
• required for whole blood calibration procedures of automated hematology analyzers;
• necessary for the assignment of values to control materials used in hemoglobin measurement procedures;
• necessary in the evaluation of instruments and alternative methods for the measurement of hemoglobin concentration;
• applicable when patient red cell measurement means are used for calibration or control of hematology analyzers10,11; and
• applicable in the routine hematology laboratory for diagnostic purposes and for monitoring the progress of therapy.
Thus, this standard is intended for all clinical laboratory personnel and for manufacturers of instruments, reagents, and calibration and control materials for the measurement of hemoglobin concentration.
This document is available in electronic format only.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
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.
Part I of this standard describes the determination of hemoglobin concentration in human blood by the HiCN (cyanmethemoglobin) method. Accurate determination of hemoglobin concentration is:
• required for whole blood calibration procedures of automated hematology analyzers;
• necessary for the assignment of values to control materials used in hemoglobin measurement procedures;
• necessary in the evaluation of instruments and alternative methods for the measurement of hemoglobin concentration;
• applicable when patient red cell measurement means are used for calibration or control of hematology analyzers10,11; and
• applicable in the routine hematology laboratory for diagnostic purposes and for monitoring the progress of therapy.
Thus, this standard is intended for all clinical laboratory personnel and for manufacturers of instruments, reagents, and calibration and control materials for the measurement of hemoglobin concentration.
This document is available in electronic format only.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.