Measurement Uncertainty of Values Assigned to Sysmex Haematology Calibrator SCS-1000

• Measurement Uncertainty of Values Assigned to Sysmex Haematology Calibrator SCS-1000

AUTHOR(S)

Christina ROOS^＊１, Etsuro SHINKAI^＊２ and Keiji FUJIMOTO^＊２

*1 Product Marketing, Sysmex Europe GmbH
*2 Scientific Affairs, Sysmex Corporation

SUMMARY

The laboratory accreditation system based on ISO 15189 requires medical laboratories to ensure traceability of measurement results and estimate their measurement uncertainty. SCS-1000 — the calibrator for Sysmex haematology analysers — is provided with assigned values traceable to international conventional reference measurement procedures and with measurement uncertainty data, thus enabling the laboratory to fulfill the requirements of ISO 15189 in this respect. Following a short introduction on traceability and measurement uncertainty as fundamental concepts for assuring reliability and comparability of measurement results, this article describes the estimation of measurement uncertainty in general and for the values assigned to SCS-1000, using the erythrocyte count as an example.

KEY WORDS

Uncertainty, Traceability, ISO 15189, GUM, Blood Cell Counting, Haematology, Calibrator