HbA1c in lyophilized hemolysates

Description

• General description: LNE CRM HbA1c 402 is a higher-order certified reference material produced by the French metrological institute LNE in compliance with ISO 17034 requirements. This Certified Reference Material LNE CRM HbA1c 402 corresponds to lyophilized human blood hemolysates and is intended for use as quality control materials for the verification of the accuracy of the reference method and routine methods used in clinical laboratories for the quantification of HbA1c in hemolysate or whole blood. Sample commutability was assessed through an extensive study involving seventeen of the most used method for the quantification of HbA1c in clinical laboratory using the difference in bias approach described in the IFCC recommendations on commutability assessment. Commutability results are reported in the certificate of analysis.Cert_ LNE CRM HbA1c 402
• Application: HbA1c in lyophilized hemolysates (LNE CRM HbA1c 402) is intended for use as quality control material to assess the measurement bias or measurement uncertainty of established or new measurement procedures for the determination of HbA1c in hemolysate or whole blood.
• Features and Benefits: This certified reference material (CRM) provides a reliable and consistent resource for HbA1c measurement in clinical diagnostic assays. The HbA1c concentration of this material is certified using the IFCC reference method via LC/MS and is derived from real patient samples.This CRM is pooled, tested, and certified by the LNE, which includes extensive commutability studies. Commutability is assessed for the main routine assays. Target values are certified using higher-order reference methods that are calibrated using primary standards of certified purity or certified reference materials, which allows the establishment of metrological traceability of results to the SI units. The accuracy of the reference methods used to certify target values is verified using certified matrix reference materials. Certified reference materials referenced by the Joint Committee for Traceability in Laboratory Medicine (JCTLM) as higher order standards
• Other Notes: Details on storage, safety, usage, and operating instructions are provided in the comprehensive Certificate of Analysis. This clinical matrix CRM is for research and clinical testing applications.