For in vitro diagnostic use only.

Intended Use

Bioclot Protein S-300 ACT is a test kit intended for the quantitative determination of Protein S activity in citrated human plasma using a clotting assay.

Principle

Protein S is a Vitamin K-dependent plasma protein, which serves as a cofactor for the anticoagulant activity of activated Protein C in the degradation of Factors V and VIII. The Bioclot method is similar to a standard factor assay. Dilutions of normal plasma are mixed with Protein S depleted plasma. The mixed plasma is then activated by a reagent, which contains Factor Xa, activated Protein C, and phospholipid. After a five-minute activation time, clot formation is initiated by the addition of Calcium Chloride. Under these conditions, the prolongation of the clotting time is directly proportional to the concentration of Protein S in the patient plasma.

The use of Factor Xa as the activator minimizes the potential interference by high levels of Factor VIII as found in some patients.

Reagents -- Composition, Packaging, Storage and Stability

Bioclot Activator Reagent: 1 ml, freeze-dried. Each vial contains human activated Protein C, Bovine Factor Xa, rabbit brain phospholipid, and Sodium Azide as a preservative.

Protein S Depleted Plasma: 1 ml, freeze-dried. Each vial contains human plasma that has been depleted of Protein S by immunoadsorption on a column of immobilized goat antibody to human Protein S.

Sample Dilution Buffer (10x Concentrate): 2.5 ml concentrate. Each vial contains buffer concentrate with Sodium Azide at 0.2%, which, when diluted, contains 0.2M NaCl, 0.03M Hepes, and 0.015M Sodium Azide at pH 7.35. The buffer also contains VPolybrene® sufficient to neutralize up to 1.2 U/ml heparin in the plasma sample.

All unreconstituted reagents are stable until the expiration date stated on the box and vial labels when stored at 2-8°C. Do not use the component beyond use by date.