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For in vitro diagnostic use only

Intended Use

Biopool's LA® Positive Control Plasma is an assayed abnormal plasma for in vitro diagnostic use in the quality control of assays for the detection of Lupus Anticoagulant in human plasma.

Principle

The term "Lupus Anticoagulant" (LA) was initially used over 20 years ago to generally describe non-specific circulatory inhibitors to coagulation, which had earlier been observed in cases of Systemic Lupus Erythematosis (SLE). It is well known today that the presence of LA goes well beyond patients with SLE and is associated with a variety of thrombotic syndromes. Phospholipid-dependent coagulation tests can be used to detect the anti-phospholipid immunoglobulins characteristic of LA. Common tests used in screening for the presence of LA, as recommended by the Scientific and Standardization Committee of the ISTH, Subcommittee for the Standardization of Lupus Anticoagulation, are: Kaolin Clotting Time (KCT), modified APTT's, dilute Russell's Viper Venom Time (DRVVT), and Tissue Thromboplastin Inhibition (TTI).

Reagent -- Composition, Packaging, Storage and Stability

LA® Positive Control Plasma, dried, (6 x 1ml). Derived from human donors who are positive for LA (and not on coumadin for at least 30 days). Plasma is processed to be platelet poor, buffered, and freezedried. Store at 2-8° C. LA® Positive Control Plasma is stable for 8 hours when stored at 2-8° C. Warm to room temperature before each use.

Cleared: FDA