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Details : C18RMP14 - JSLH reference measurement procedure for enumeration of leukocytes
| Type (acronym) | rmp |
|---|---|
| Type | reference measurement procedure |
| Unique Nomination Number | C18RMP14 |
| Analyte Name | leukocyte |
| IUPAC IFCC Number | leukocyte |
| Method capable of Traceability of Analyte to SI or Defined Procedure | defined procedure: standard impedance counter (SIP)and standard operating procedure(SOP) and SI (concentration of cells)
|
| Applicable Matrices | whole blood; fresh |
| Name | JSLH reference measurement procedure for enumeration of leukocytes |
| Organization that developed Validated Method | The Japanese Society for Laboratory Hematology (according to documents provided by the International Council for Standardization in Haematology) |
| Measurement Techniques Used | Standard impedance counter (SIC) and standard operating procedure (SOP) including of validation and verification method for concentration of erythrocytes and leukocytes |
| Quantity | Particle concentration |
| From (0) | 3 |
| To (0) | 10 |
| Unit (0) | 109/L |
| From (1) | 2.3 |
| To (1) | 2.3 |
| Unit (1) | % |
| Level of Confidence (%) | 95% |
| Peer Reviewed Publication | Reference measurement procedure for the enumeration of erythrocytes and leukocytes, Revision 01-06e, 2025-5-20 Download Subcommittee on Standardization of Blood Cell Counting (SBCC) The Japanese Society for Laboratory Hematology (JSLH) |
| Comments to be published via JCTLM DB | An internationally agreed protocol shall be used to assign the quantity values to the international conventional calibrators. The calibrators for the measurand in erythrocyte (Red blood cell: RBC) and leukocyte (White blood cell: WBC) counting are human samples within 8 hours after blood collection. All manufacturers of automated hematology analyzers have been using the ICSH procedure as an internationally agreed protocol [1] [2]. Hence, most manufacturers of automated hematology analyzers use the ICSH procedure as a higher order reference measurement procedure (RMP) according to ISO 17511:2020. However, the ICSH procedure has been complemented with some descriptions to comply with ISO15193:2009. The listed RMP for RBC and WBC was performed using standard impedance counter (SIC) with single channel and the standard operation procedure (SOP) and validated by the ICSH reference method, because no specified standard counter is commercially available. The RMP was performed in reference laboratories of manufacturers, or laboratories providing the SIC and the SOP. As a special case, the SIC and SOC may be implemented by non-manufacturers and in operation for external quality assurance of routine measurement [3]. This document specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to human samples and human calibrator for quantities measured by IVD MDs. [1] The assignment of values to fresh blood used for calibrating automated blood cell counters. Clin. Lab; Haematol. 1988 10: 203-212 [2] Reference method for the enumeration of erythrocytes and leucocytes. Clin. Lab. Haematol. 1994 16: 131-138 [3] Flow cytometer for reference measurements of blood cell concentrations with low uncertainty. 2015 IEEE MeMeA 517-520. DOI: 10.1109/MeMeA.2015.7145258 |
| Analyte Category Name | Blood cell counting |
| Measurement principle/technique | Standard impedance counter |