DiaPharma Group, Inc.

Intended use

Automated coagulation functional assay for the quantitative determination of free Protein S in human citrated plasma on IL Coagulation Systems.

Summary and principle

Protein S is a vitamin K-dependent cofactor for the anticoagulant and the profibrinolytic effects of activated Protein C. Two forms of Protein S are present in plasma: free Protein S (40%), and Protein S linked to the complement C4b-binding protein (C4BP) (60%). Only free Protein S has functional cofactor activity.

Protein S deficiency may be hereditary or acquired. Acquired deficiency may be observed during pregnancy, oral anticoagulant therapy, oral contraceptive use, in liver disease, in newborn infants as well as in other clinical conditions.Deficiency of Protein S has been associated with a high risk of developing venous thromboembolism especially in young people.

The ProS assay determines the functional activity of free Protein S by measuring the degree of prolongation of a prothrombin time in the presence of the tissue factor, phospholipids, calcium ions and activated Protein C. The Protein S activity is proportional to the prolongation of the clotting time of a Protein S deficient plasma to which diluted sample has been added.

Composition

Protein S reagent (Cat. No. 0020002810): 3 x 3 mL vials of a lyophilized preparation containing recombinant rabbit tissue factor, synthetic phospholipids, calcium ions, activated Protein C, polybrene, buffer, stabilizers and preservatives.

Stability after reconstitution:

• ACL® 100-7000 Systems: 2 days at 2-8°C, 15 days at -20°C in the original vial or 2 days at 15°C on-board. No stirring is required.
• ACL 8000/9000/10000 Systems: 2 days at 2-8°C, 15 days at -20°C in the original vial or 4 hours at 15°C on-board. No stirring is required.
• ACL Futura® and ACL Advance Systems: 16 hours at 2-8°C, 7 days at -20°C in the original vial or 4 hours at 15°C on-board. No stirring is required.

Protein S deficient plasma (Cat. No. 0020002820): 5 x 1 mL vials of a lyophilized human plasma which has been artificially depleted of Protein S. Stability after reconstitution: 4 hours at 15-25°C in the original vial or 7 days at -20°C.

Protein S control plasma (Cat. No. 0020002830): 2 x 1 mL vials of a lyophilized human plasma containing a low level of Protein S. Stability after reconstitution: 4 hours at 15-25°C in the original vial or 7 days at -20°C.

Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.

Notes:

• Frozen reagent and plasmas should be thawed at 37°C and gently mixed before use. Before freezing they can be aliquoted using plastic tubes and stoppers. Do not refreeze.
• For optimal stability remove reagents from the system and store them at 2-8°C in the original vial.

Additional reagents and control plasmas
The following are not supplied with the kit and must be purchased separately.

• Calibration plasma (Cat. No. 0020000000)
• Normal Control (Cat. No. 0020003120)
• Low Abnormal Control (Cat. No. 0020003220)
• High Abnormal Control (Cat. No. 0020003320)
• Factor diluent (Cat. No. 0009757600)