Factor IX (F9, FIX) ELISA Kit
The VisuLize Factor IX Antigen Kit is intended to quantitatively measure factor IX antigen in human plasma and factor concentrates. The biological importance of Factor IX is demonstrated in Hemophilia B (Christmas disease), an X-linked congenital bleeding disease resulting from a quantitative (low activity and low antigen) or qualitative (low activity and normal antigen) defect in Factor IX function. The congenital deficiency of Factor IX may be classified as severe (1% Factor IX activity), moderate (between 1 and 5% Factor IX activity) or mild (between 5 and 40% Factor IX activity). The laboratory diagnosis of Factor IX deficiency typically involves quantitative determinations of procoagulant levels i.e., functional activity of Factor IX.¹ An ELISA for Factor IX antigen may be used in conjunction with functional assays in the area of gene therapy, assessment of Factor IX concentrates, determination of carrier status as well as distinguishing those patients with cross-reactive material (i.e., low functional activity but near normal antigen levels of Factor IX).
This product is cleared for in vitro Diagnostic use by FDA, Health Canada and CE marked. Available for sale in the United States, Canada and select European countries.
Factor IX ELISA kit principles:
Strip wells are pre-coated with sheep polyclonal antibody to human Factor IX. Plasma samples are diluted and applied to the wells. The FIX antigen present binds to the coated antibody. After washing away unbound material, peroxidase labeled sheep detecting antibody is applied and allowed to bind to the captured FIX. The wells are again washed and a solution of TMB (the peroxidase substrate tetramethylbenzidine) is applied and allowed to react for a fixed period of time. A blue color develops which changes to yellow upon quenching the reaction with acid. The color formed is measured spectrophotometrically in a microplate reader at 450nm. The absorbance at 450nm is directly proportional to the quantity of FIX antigen captured onto the well. The assay is calibrated using the calibrator plasma provided in the kit.
Abormal Control Plasma – Lyophilized
The VisuCon-L Abnormal Control Plasma – Lyophilized is an assayed control plasma intended for use in the quality control of coagulation assays in the borderline pathological range. This control plasma may be used to monitor the performance of coagulation assays for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX, X, XI, XII, antithrombin activity, Protein C activity, and Protein S activity.
This Abnormal Control Plasma – Lyophilized may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents. Good laboratory practice requires that assays be calibrated over the relevant range and that controls be performed regularly to confirm assay calibration. This plasma is citrated human Pooled Normal Plasma – PNP collected from a minimum of 20 donors, buffered with 0.05M HEPES buffer, as well as stabilizing agents, dispensed and lyophilized.
VisuCon-L Abnormal Control Plasma – Lyophilized is cleared for in vitro Diagnostic use by FDA and CE marked. Available for sale in the United States and select European countries.
- Box containing 10 x 1 mL vials of lyophilized plasma, Prod. # LYABP01
The results obtained with the VisuCon-L Abnormal Control Plasma – Lyophilized will be subject to the limitations of the assay system including types of reagents and instrumentation.
Reconstitute each vial with 1 ml reagent grade water. Swirl gently and let stand for 15 minutes. Swirl gently once more before use.
Storage and Stability:
Vials are stable until the expiration date stated on the vial when stored at 2 – 8°C. Once reconstituted, the plasma is stable for 24 hours on-board (15 – 22°C) or at 2 – 8°C in original vial. Gently mix vial of plasma if left for more than 2 hours without use. Reconstituted material should be discarded after use and not be refrozen.
After reconstituting the VisuCon-L Abnormal Control Plasma – Lyophilized, use on coagulation instrument or assay system with corresponding reagents in accordance with established coagulation assay procedures. If appropriate control values are not obtained, assess the components of the assay system including reagents, substrate plasmas, calibrator plasma or instrumentation to try and identify potential sources of error.
Product Datasheet: VisuCon-L Abnormal Control Plasma - Lyophilized - Product Insert