DiaPharma Group, Inc.

Intended use

For the quality control in the abnormal range of the chromogenic tests (Antithrombin, Plasminogen, Plasmin Inhibitor and Protein C) and Free Protein S assay. For the Quality Control of von Willebrand Factor assay in the normal (Level 1) and abnormal range (Level 2).

Summary and Principle

The Control Plasma Abnormal Level 1& 2 is prepared from human citrated plasma from healthy donors by means of a dedicated process to provide reliable controls in the whole abnormal range.

Level 1: Abnormal levels for the chromogenic tests and the Free Protein S assay in the range of 50-60% activity. It is intended for the assessment of precision and accuracy of the tests in the mid abnormal range. von Willebrand Factor values are within the normal range.

Level 2: Abnormal levels for the chromogenic tests and the Free Protein S assay in the range of 20-30% activity. It is intended for the assessment of precision and accuracy of the chromogenic tests for patients undergoing thrombolytic therapy. von Willebrand Factor values are in the low abnormal range.

Use of both controls is recommended for a complete quality control program.

Reagents -- Composition, Packaging, Storage and Stability

1 Control Plasma Abnormal Level 1: 5 x 0.5 mL vials of lyophilized human plasma containing buffer and stabilizers. No preservatives are included.

2 Control Plasma Abnormal Level 2: 5 x 0.5 mL vials of lyophilized human plasma containing buffer and stabilizers. No preservatives are included.

Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C. Stability after reconstitution: 8 hours at 15-25°C or 24 hours at -20°C in the original vial. Frozen controls may be thawed at 37°C and gently mixed before use. Do not refreeze. For optimal stability remove controls from the system and store them at 2-8°C in the original vials.