DiaPharma Group, Inc.

For in vitro diagnostic use

Intended use

Chromogenic substrate to be used in combination with the Liquid Antithrombin kit (Cat. No. 0020002500) for the quantitative determination of Antithrombin in human citrated plasma on the IL Coagulation Systems.

Summary and principle

Antithrombin (AT) or Heparin Cofactor I is the major inhibitor of blood coagulation and is essential for effective heparin therapy. By inhibiting the coagulation proteases, especially thrombin, FXa and FIXa, AT prevents uncontrolled coagulation. Antithrombin deficiency is associated with a high risk of thromboembolic disorders.

The Liquid AT Substrate kit, in conjunction with the Liquid Antithrombin kit, can be used to exclude or diagnose hereditary deficiencyin patients with a tendency toward thromboembolism, in pre-operative stages, before prescription of oral contraceptives, DIC6, nephrotic syndrome, liver diseases,and in therapy with heparin or antithrombin concentrates.

Reagents -- Composition, Packaging, Storage and Stability

Chromogenic substrate (Cat. No. 0020002520): 6 x 2 mL vials of the chromogenic substrate S-2765, N-alpha-Z-D-Arg-Gly-Arg-pNA·2HCl (6 mg/vial), surfactant and buffer.

Unopened reagent is stable until the expiration date shown on the vial when stored at 2-8°C. Opened reagent is stable: 5 weeks at 2-8°C in the original vial, 48 hours at 15-25°C on the ACL® 8000/9000/10000, 8 hours at 15-25°C on the ACL Classic or 48 hours at 15°C on the ACL Futura® and ACL Advance Systems. Do not freeze.

For optimal stability remove reagent from the system and store it 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.

• Liquid Antithrombin (Cat. No. 0020002500)
• Calibration plasma (Cat. No. 0020000000)
• Normal Control (Cat. No. 0020003120)
• Special Test Control Level 1 (Cat. No. 0020010100)
• Special Test Control Level 2 (Cat. No. 0020010200)
• Low Abnormal Control (Cat. No. 0020003220)
• High Abnormal Control (Cat. No. 0020003320)
• Factor diluent (Cat. No. 0009757600)
• Cleaning solution (Cat. No. 0009831700)
• Cleaning agent (Cat. No. 0009832700)