DiaPharma Group, Inc.

Intended use

For the Quality Control of coagulation assays in the normal range.

Summary and principle

The Normal Control is prepared using human citrated plasma from healthy donors. It is intended for the assessment of precision and accuracy of tests performed on IL Coagulation Systems: PT, APTT, TT, Fibrinogen, Single Factors, von Willebrand Factor, Antithrombin, Plasminogen, Plasmin Inhibitor, Protein C, Protein S, Pro-IL-Complex* and Hepatocomplex*. Values for all analytes are within the normal range.

Reagent -- Composition, Packaging, Storage and Stability

Normal Control (Cat. No. 0020003100): 10 x 1 mL vials of lyophilized human plasma containing buffer, stabilizers and preservatives.

Unopened control is stable until the expiration date shown on the vial when stored at 2-8°C. Stability after reconstitution:

• at 2-8°C in the original vial for PT, Fibrinogen, APTT, TT, Antithrombin, Plasminogen, Plasmin Inhibitor, Protein C and Protein S: 24 hours
• at 2-8°C in the original vial for the remaining parameters (Factors, Pro-IL-Complex* and Hepatocomplex*): 8 hours
• at 15-25°C in the original vial for PT, Fibrinogen, APTT, TT, Antithrombin, Plasminogen, Plasmin Inhibitor and Protein C: 24 hours
• at 15-25°C in the original vial for Factors and Protein S: 4 hours
• at 15-25°C on-board the ACL® 8000/9000/10000 for PT, Fibrinogen and APTT: 24 hours
• at 15-25°C on-board the ACL Futura®/ACL Advance for PT, Fibrinogen and APTT: 24 hours

For optimal stability remove control from the system and store it at 2-8°C in the original vial.