DiaPharma Group, Inc.

Intended use

Automated latex ligand immunoassay 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.1 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 hereditaryor 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 presence of free Protein S is determined by measuring the increase of turbidity produced by the agglutination of two latex reagents. Purified C4BP adsorbed onto the first latex reagent reacts with a high affinity for free Protein S of patient plasma in the presence of Ca2+ ions.The free Protein S adsorbed on the C4BP latex triggers the agglutination reaction with the second latex reagent which is sensitized with a monoclonal antibody directed against human Protein S. The degree of agglutination will be directly proportional to the free Protein S concentration in the test sample.

Reagents -- Composition, Storage and Stabiliy

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

C4BP Buffer (Cat. No. 0020002720): 3 vials x 4 mL of Borax buffer containing bovine serum albumin, stabilizers and preservative.

C4BP Latex (Cat. No. 0020002710): 3 vials x 4 mL of a lyophilized suspension of polystyrene latex particles coated with purified human C4BP containing bovine serum albumin, stabilizers and preservative. Stability after reconstitution: 1 month at 2-8°C in the original vial, 1 week at 15°C on the ACL® 8000/9000/10000, ACL Futura®/ACL Advance Systems and ACL TOPTM. Do not freeze.

Anti-PS MAb Latex (Cat. No. 0020002730): 3 vials x 2 mL of a suspension of polystyrene latex particles coated with a monoclonal antibody directed against human Protein S containing bovine serum albumin, stabilizers and preservative. Opened reagent is stable 1 month at 2-8°C in the original vial, 1 week at 15-25°C on the ACL 8000/9000/10000 and 1 week at 15°C on the ACL Futura/ACL Advance Systems and ACL TOP. Do not freeze.

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)
• Special Test Controls Level 1 & 2 (Cat. No. 0008467600)
• Low Abnormal Control (Cat. No. 0020003220)
• High Abnormal Control (Cat. No. 0020003320)
• Factor diluent (Cat. No. 0009757600)