Intended Use
For the qualitative determination of antibodies to filgrastim in human serum or plasma.
Contents of Kit
1. Filgrastim Coated Plate: One strip well 96-well plate.
2. Biotinylated Tracer(10×): Lyophilized, One vial.
3. Streptavidin-Enzyme Conjugate (100×): One 120 μL vial.
4. Anti-Filgrastim Standard (1μg/ml): One 200 μL vial.
5. Assay Diluent: One 50 mL bottle.
6. 20× Wash Buffer: One 50 mL bottle.
7. Substrate Solution: Two 6 mL bottles.
8. Stop Solution: One 7 mL bottle.
Storage
Upon receipt, store all reagents at 2–8 °C. Equilibrate all required reagents/components to room temperature before use. Use the kit before the expiration date indicated on the label.
Precision
Precision was evaluated using high, medium, and low concentration control samples. The results are expressed as coefficient of variation percentage, CV%. Each precision level was tested with N = 10 replicates.
Detection Range
0-100ng/mL
Sensitivity
The sensitivity of the method was determined from three analytical batches. The sensitivity of the method in serum or plasma is: 0.19 × 20 (MRD) = 3.8 ng/mL
General Description
Filgrastim is a granulocyte colony-stimulating factor (G-CSF) analog used to stimulate the proliferation and differentiation of granulocytes. It is produced by recombinant DNA technology. It serves to stimulate the production of granulocytes. Granulocyte-colony stimulating factor (G-CSF) is a growth factor and an essential cytokine belonging to the colony-stimulating factor family, which regulates hematopoietic cell proliferation and differentiation.. Filgrastim is used to treat neutropenia, stimulating the bone marrow to increase production of neutrophils. The causes of neutropenia include chemotherapy and bone marrow transplantation. In various clinical trials, filgrastim has been reported to generate an antibody response. Both binding and neutralizing antibodies against filgrastim have been reported. The formation of binding or neutralizing antibodies to a therapeutic agent may decrease the efficacy of these agents, leading to a loss of clinical response over time. In some cases, anti-drug antibodies may cause infusion reactions and serious anaphylactic reactions. Detection, measurement and characterization of anti-therapeutic antibodies are critical in understanding the safety, exposure and efficacy profile of the therapeutic agent. The anti-Filgrastim ELISA kit is designed for the qualitative determination of antibodies to filgrastim in serum and plasma. Our ELISA-based kits combine a fast, user-friendly format with a sensitive and specific assay. The anti-Filgrastim ELISA kit can be used for monitoring anti-filgrastim antibodies during clinical research and offers the scientists a tool for understanding of the safety and efficacy of the filgrastim and its biosimilars.
Standard Curve
The following figures demonstrate typical results. One should use the data below for reference only. This data should not be used to interpret actual results.
Figure 1: Human anti-Filgrastim ELISA Standard Curve
Citations
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