HemosIL Calibrator is for the calibration of coagulation assays on IL Coagulation Systems.
The Calibration plasma is prepared using citrated plasma plasmapheresed from healthy donors by means of a dedicated process to maintain the characteristics of a Normal plasma pool.
It is designed for the calibration of IL Coagulation Systems in the determination of Fibrinogen, Single Factors, von Willebrand Factor, Antithrombin, Plasminogen, Plasmin Inhibitor, Protein C and Protein S.
The Calibration plasma kit consists of C Calibration plasma (Cat. No.0020003710): 10 x 1 mL vials of lyophilized human plasma containing buffer, stabilizers and preservatives.
This product is For in vitro Diagnostic Use.
Dissolve the contents of each vial with 1 mL of CLSI CLRW Type water or equivalent.2 Replace the stopper and swirl gently. Make sure of the complete reconstitution of the product. Keep the Calibration plasma at 15-25°C for 30 minutes and invert to mix before use. Do not shake. Avoid foam formation.
Unopened Calibration plasma is stable until the expiration date shown on the vial when stored at 2-8°C.
Stability after reconstitution:
- 24 hours at 2-8°C in the original vial for Fibrinogen, Antithrombin, Plasminogen, Plasmin Inhibitor, Protein C and Protein S.
- 8 hours at 2-8°C in the original vial for Factors.
For optimal stability remove Calibration plasma from the system and store it at 2-8°C in the original vial.
After reconstitution the Calibration plasma should be handled in the same manner as fresh citrated plasma.
Refer to the instrument’s Operator’s Manual and/or Application Manual for the complete assay procedure instructions according to the specific tests required.
The reported reference values were determined over multiple runs on IL Coagulation Systems using specific lots of IL reagents and against a Calibration Plasma House Standard, which is traceable to the current International Standards (Fibrinogen, Antithrombin, Protein C, Protein S, Factors II, X, VII, VIII, IX, XIII and von Willebrand Factor), identified in the reference values table.
For the tests where International standards are not available, these parameters (i.e. Plasminogen, Plasmin Inhibitor and Factors V, XI, and XII) have been assigned against a House Standard, which is traceable to a frozen normal plasma pool of 100 donors.
Calibration plasma, when used as a calibrator on IL Coagulation Systems according to IL recommendations, demonstrates commutability with patient samples.
This product is designed for the calibration of coagulation assays. The Calibration plasma is subjected to the limitations of the assay system.