Certificate of Analysis

Transcription

1 Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str Marburg Germany Customer To whom it may concern Certificate of Analysis Material: Kit-: Total lot size: 445 PCK Delivery amount: Commission-No. Customer-Order-No. Customer-No. Storage at: 2-8 C Release date: Manufacturing date: Expiration date: Legal Material Number: OUIA15 Material: Kit components: Level Release date Material-Name 0010 OUIB C1-Esterase 0020 OUIC Substrat Reagent 0030 OUIS Substrat Solvent Page 01 from 05

2 Inspection results: Card box Examination of the test kit and the content with respect to completeness and visible deficiencies (material name, material code, lot number, shelf life, CE mark). Final confection order / Kit components The following indications for the final confection order will be verified for conformity with the kit components: ID-code of the package insert, product names for all components, expiration date of all components, material numbers of all components, lot designations of all components. Barcode verification on BCS/BCS XP System Verification of the legibility of the barcode from a BCS System or BCS XP System filling. Inherent extinction/substrate concentration Determination of the inherent extinction of the substrate and the substrate concentration in double determination on photometer. Self-Absorbance Substrate concentration 0,009-0,020 - Page 02 from 05

3 ,9-1,2 0,8 Function test Create a reference curve with Standard Human Plasma. Determination of the activity of C1-inhibitor [% of norm] in control plasma in 5 fold determination according current instruction for use and reference guide. Control Plasma N Control Plasma P 102,0 % - 116,0 % 78,0 % 33,3 % - 46,0 % 28,0 % Sensitivity test at +30 C Calculation of the laboratory internal factor at +30 C. Determination of the C1-esterase enzyme value (CEV) with physiological saline solution and the reference measurement value with Standard Human Plasma according current instruction for use. Factor / FL Internal laboratory factor Page 03 from 05

4 47066 Sensitivity test at +37 C Calculation of the laboratory internal factor at 37 C. Determination of the C1-esterase enzyme value (CEV) with physiological saline solution and the reference measurement value with Standard Human Plasma according current instruction for use. Factor / FL Internal laboratory factor Specificity Determination of the C1-Inhibitor activity of controls and calculation of the deviation of the target value. Control Plasma N Control Plasma P 4,6 % - 15,0 % -15,0 % -11,8 % - 15,0 % -15,0 % Reproducibility CPN Control Plasma N will be tested in at least 5-fold determinations. CV Coefficient of variation Page 04 from 05

5 ,3 % - 10,0 % - Reproducibility CPP Control Plasma P will be tested in at least 5-fold determinations. CV Coefficient of variation 4,7 % - 10,0 % - This document was generated by means of electronic data system, therefore without signature. Page 05 from 05