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LNEHBA1C401

HbA1c in lyophilized hemolysates

LNE Certified Reference Material, commutable, JCTLM listed

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form

liquid

quality

commutable, JCTLM listed

shelf life

limited shelf life, expiry date on the label

composition

lyophilized human blood hemolysates, 100%

IVD

not for in vitro diagnostic use

storage temp.

2-8°C

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General description

LNE CRM HbA1c 401 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 401 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 401

Application

The LNE CRM HbA1c 401 is a reference material designed for use as quality control material. It is intended for evaluating the measurement bias or uncertainty of existing or new measurement procedures for determining HbA1c in hemolysate or whole blood.

Features and Benefits

  • A reliable and consistent reference material for HbA1c measurement in clinical diagnostic assays. 
  • Certified for their HbA1c concentration using the IFCC reference method through LC/MS. 
  • 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. 
  • Recognized 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. 

Storage Class

10 - Combustible liquids

wgk_germany

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable


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