| The Coagulation Factor Calibrator Plasma is a lyophilized reference plasma intended for use in the calibration of Antigen assays for factor II, factor VII, factor X, factor XI, factor XIII, Protein C, Protein S, Antithrombin III, von Willebrand Factor and fibrinogen by ELISA. It is prepared from a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with HEPES and stabilizers and lyophilized. |
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| Catalog # | C7463 |
| The Coagulation Factor Calibrator Plasma is compatible for use with the following “Antibodies Only” ELISA kits | A2298-19: Antithrombin (ATIII) BioAssay™ ELISA Kit (Antibodies only) |
| F0015-25: Factor VII BioAssay™ ELISA Kit (Antibodies only) (F.VII, Stable Factor, Proconvertin) |
| F0018-09: Factor X BioAssay™ ELISA Kit (Antibodies only) |
| F0018-57: Factor XI BioAssay™ ELISA Kit (Antibodies only) |
| F0019-48: Factor XIII BioAssay™ ELISA Kit (Antibodies only) |
| F4202: Fibrinogen BioAssay™ ELISA Kit (Antibodies only) |
| P9102-38: Protein C BioAssay™ ELISA Kit (Antibodies only) |
| P9108-07: Protein S BioAssay™ ELISA Kit (Antibodies only) |
| P9117: Prothrombin BioAssay™ ELISA Kit (Antibodies only) |
| V2700-09: Von Willebrand Factor (vWF) BioAssay™ ELISA Kit (Antibodies only) |
| Lot-specific antigen reference values for each analyte are provided, which were determined against the SSC/ISTH secondary coagulation standard. For those analytes where antigen assignments have not been determined, activity value assignments have been used, assuming 1 U/mL activity = 1 U/mL antigen. |
| Typical Antigen Values | Fribrinogen Antigen ~3.g/L |
| Factor II Antigen ~1uUml |
| Factor VII Antigen ~0.9U/ml |
| Factor X Antigen ~1U/ml |
| Factor XI Antigen ~1U/ml |
| Factor XIII Antigen ~0.7U/ml |
| Protein C Antigen ~1U/ml |
| Protein S Antigen ~0.8U/ml |
| vWF Antigen ~1U/ml |
| Antithrombin Antigen ~0.9U/ml |
| Storage and Stability | Lyophilized plasma may be stored at -20°C. Stable unopened for 12 months at -20°C. Reconstitute with sterile ddH2O. Reconstituted plasma is stable for 2 hours at RT (18-25°C) or 30 days at -20°C in the original vial. Thaw frozen plasma at 37°C for 5 minutes. Discard thawed plasma after 2 hours at RT. |
| EXCEPTION: Frozen calibrator plasma should not be used for determination of Protein C antigen; use a freshly reconstituted vial for this analyte. |
| Quality Control | Each laboratory should establish and maintain its own quality control ranges for the particular ELISA assay used. If appropriate control values are not obtained, the test sample antigen values should be considered suspect. |
| Limitations of the Procedure | The results obtained with the Coagulation Factor Calibrator Plasma will be subject to the limitations of the ELISA assay system. Test samples should be of the same matrix and anticoagulant as the calibrator plasma (citrated plasma). |
| Note | This product is intended for Research Use Only and must not be used for diagnostic applications or the calibration of coagulation activity assays. This product contains human source material. Each unit of source plasma used in the preparation of this product has been tested by FDA approved methods and found negative for the presence of Human Immunodeficiency Virus (HIV) Type 1 and Type II. Hepatitis B surface antigen (HbsAg) as well as for Hepatitis C (HCV). As no test can offer complete assurance that products derived from human blood will not transmit infectious diseases, this product should be handled as potentially infectious material. |
| Form | Supplied as a lyophilized plasma. Reconstitute with 1ml of sterile ddH2O. Mix gently and allow to stand for 15 minutes at RT prior to use. Shake gently once more before use. |
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| Important Note | This product as supplied is intended for research use only, not for use in human, therapeutic or diagnostic applications without the expressed written authorization of United States Biological. |
