HCG校准品溯源性报告英文.pdfVIP

® LIAISON XL HCG REF 312321 Calibrator Traceability Report Product Composition ®  LIAISON XL HCG Calibrator low: Liquid solution, ready to use; 1.0 mL/vial; 1 vial/kit HCG in phosphate buffer Approximate concentration: 16 mIU/mL ®  LIAISON XL HCG Calibrator high: Liquid solution, ready to use; 1.0 mL/vial; 1 vial/kit HCG in phosphate buffer Approximate concentration: 3500 mIU/mL Calibrator Specification ®  LIAISON XL HCG Calibrator low: Approximate concentration : 16 ±3 mIU/mL ®  LIAISON XL HCG Calibrator high: Approximate concentration : 3500 ± 500 mIU/mL Tracebility Calibrator XL HCG_V2.0-QA_12/201 3 – page 1 Traceability Statement for LIAISON® XL HCG Values assigned to the LIAISON® XL HCG calibrators are traceable via internal reference preparations to the 3rd WHO reference standard IS 75/537. The preparation of internal reference and of calibrators is described by detailed internal SOPs. The HCG antigen is used to produce the LIAISON® XL HCG calibrators. Commutability Statement for LIAISON® XL HCG Assay The commutability of the LIAISON® XL HCG calibrators for HCG has been demonstrated using the LIAISON® XL HCG kit. Commutability of these calibrators has not been established with other HCG methods. The Estimation of Uncertainty ® The uncertainty of the values assigned to the LIAISON XL HCG Calibrators is as follows: ® LIAISON HCG Calibrator low: 16 mIU/mL ± 10 % (1.6 mIU/mL) ® LIAISON HCG Calibrator h