铁蛋白校准品溯源报告 Traceability Calibration Ferritin.docVIP

DiaSorin Germany GmbH von-Hevesy-Str. 3 D-63128 Dietzenbach Phone: +49 (0)6074 - 401-0 Fax: +49 (0)6074 - 401-209 LIAISON? Ferritin Catalogue Number 313.551 Calibrator Composition and Specifications Calibrator Traceability Report Product Composition LIAISON? Ferritin Calibrator low: Liquid solution, ready to use; 1 ml/vial; 1 vial/kit human Ferritin in human albumin solution Approximate concentration: 13 ng/mL LIAISON? Ferritin Calibrator high: Liquid solution, ready to use; 1 ml/vial; 1 vial/kit human Ferritin in human albumin solution Approximate concentration: 1700 ng/mL Calibrator Specifications LIAISON? Ferritin Calibrator low: Approximate concentration: 13 ± 3 ng/mL LIAISON? Ferritin Calibrator high: Approximate concentration: 1700 ± 150 ng/mL  LIAISON? Ferritin Cat.No. 313.551 Calibrator Traceability Report page 2 of 3 Traceability Statement for LIAISON? Ferritin human serum and plasma Values assigned to the LIAISON? Ferritin calibrators are traceable via internal reference preparations to the WHO 2nd International Standard 80/ 578. The preparation of internal reference and of calibrators is described by detailed internal SOPs. The Ferritin antigen is used to produce the LIAISON? Ferritin calibrators. Commutability Statement for the LIAISON? Ferritin Assay The commutability of the LIAISON? Ferritin calibrators for Ferritin has been demonstrated using the LIAISON? Ferritin kit. Commutability of these calibrators has not been established with other Ferritin methods. The Estimation of Uncertainty The uncertainty of the values assigned to the LIAISON? Ferritin calibrators is as follows: Calibrator low = 13 ng/mL ± 7 % (0.91 ng/mL) and Calibrator high = 1700 ng/mL ± 7 % (119 ng/mL).  LIAISON? Ferritin Cat.No. 313.551 Calibrator Traceability Report page 3 of 3 Reference Material/ Measurement Procedure Calibrators