DiaPharma Group, Inc.

For in vitro diagnostic use.

Intended use

For the Quality Control of coagulation assays in the low abnormal range.

Summary and principle

The Low Abnormal Control 2 is prepared from human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified, by means of a dedicated process, to simulate an abnormal coagulation sample.

It is intended for the assessment of precision and accuracy of tests performed on the IL Coagulation Systems: PT, APTT, TT, Antithrombin, Protein C, Protein S, Pro-ILComplex*, Hepatocomplex*. Values for all analytes are in the low abnormal range.

Reagent -- Composition, Packaging, Storage and Stability

Low Abnormal Control (Cat. No. 0020003200): 10 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, APTT, TT, Antithrombin, Protein C and Protein S: 24 hours
• at 2-8°C in the original vial for the remaining parameters (Pro-IL-Complex* and Hepatocomplex*): 8 hours
• at 15-25°C in the original vial for PT, APTT, TT, Antithrombin and Protein C: 24 hours
• at 15-25°C in the original vial for Protein S: 4 hours
• at 15-25°C on-board the ACL® 9000/10000 and the ACL Futura® and ACL Advance for PT and APTT: 24 hours

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