HemosIL Special Test Control L2 is for the quality control in the high abnormal range of the chromogenic tests (Antithrombin, Plasminogen, Plasmin Inhibitor Protein C and Factor VIII), free Protein S and factor assays (clotting) performed on the IL Coagulation Systems.
For the Quality Control of von Willebrand Factor Antigen and Factor XIII Antigen in the low abnormal range on the IL Coagulation Systems.
The Special Test Control Level 2 is prepared from human citrated plasma from healthy donors and modified, by means of a dedicated process, to simulate an abnormal coagulation sample. It is intended for the assessment of precision and accuracy of the chromogenic tests, free Protein S and factor assays (clotting) in the range of 20 – 40% activity. von Willebrand Factor Antigen and Factor XIII Antigen are in the low abnormal range. Use of normal and abnormal controls is recommended for a complete quality control program.
The Special Test Control Level 2 consists of 2 Special Test Control Level 2 (Cat. No. 0020012100): 10 x 1.0 mL vials of lyophilized human plasma containing buffer and stabilizers. No preservatives are included.
This product is For in vitro Diagnostic Use.
Dissolve the contents of each vial with 1.0 mL of CLSI Type CLR water or equivalent. Replace the stopper and swirl gently. Make sure of the complete reconstitution of the product. Keep the control at 15-25°C for 30 minutes and mix gently before use. Do not shake. Avoid foam formation.
Unopened control is stable until the expiration date shown on the vial when stored at 2-8°C.
Stability after reconstitution: 8 hours at 15-25°C or 24 hours at -20°C in the original vial. Frozen controls may be thawed at 37°C and gently mixed before use. Do not refreeze. For optimal stability remove control from the system and store it at 2-8°C in the original vials.
After reconstitution the Special Test Control Level 2 should be handled in the same manner as fresh citrated plasma.
The reported values were determined over multiple runs on IL Coagulation Systems using a specific lot of reagent and against a Calibration Plasma House Standard which is traceable to the current International Standards, identified in the acceptance range table.
For the tests where International Standards are not available, these parameters (i.e. Plasminogen, Plasmin Inhibitor, Factors V, XI and XII) have been assigned against a House Standard which is traceable to a frozen normal plasma pool of 100 donors.
This product is designed as an abnormal control for monitoring chromogenic, free Protein S, factor assays and von Willebrand Factor Antigen. The control is subjected to the limitations of the assay system. Deviations in control values may indicate possible problems with one or more components in the test system.
Refer to specific reagent inserts for performance characteristics. The reported ranges were determined over multiple runs on IL Coagulation Systems using specific lots of IL reagents. The mean of the control range determined in your laboratory may vary due to the lot of reagent used.
Due to differences in reagents and instrumentation, each laboratory should establish its own Target Value and Acceptance Range (mean and standard deviation). However, any properly functioning coagulation system should yield mean values within the Acceptance Range on the package insert.