Degarelix (Firmagon) ELISA Kit

Sample

Serum, plasma and cell culture supernatant

Species Reactivity

Human

Intended Use

The Degarelix (Firmagon) ELISA is used to estimate the level of Degarelix in human serum and plasma. The kit is intended for research use only.

Storage

1. Reconstitute or dilute only the specific reagents mentioned in the reagent preparation section, when ready to run the assay.
2. All kit components should be stored in the refrigerator (2- 4°C) up to the kit's expiration date.
3. Do not use kit components after the expiration date.
4. Before using, bring all components to Room Temperature (18-25°C). Upon assay completion return all components to appropriate storage conditions.
5. ELISA plate pouches contain desiccant. Keep the plates sealed in the pouch with desiccant in the refrigerator when not in use.

Precision

Intra-assay Precision: 3 samples with low, middle and high level human Degarelix were tested 20 times on one plate, respectively.
Inter-assay Precision: 3 samples with low, middle and high level human Degarelix were tested on 3 different plates, 8 replicates in each plate.
CV (%) = SD/mean x 100
Intra-Assay: CV<10%
Inter-Assay: CV<12%

Sensitivity

The minimum detectable dose of Degarelix is typically less than 40 ng/ml. The sensitivity of this assay, or Lower Limit of Detection (LLD) was defined as the lowest protein concentration that could be differentiated from zero. It was determined by subtracting two standard deviations to the mean optical density value of twenty zero standard replicates and calculating the corresponding concentration

General Description

Degarelix is used for the treatment of advanced prostate cancer. Degarelix is a synthetic peptide derivative drug which binds to gonadotropin-releasing hormone (GnRH) receptors in the pituitary gland and blocks interaction with GnRH. This antagonism reduces luteinizing hormone (LH) and follicle-stimulating hormone (FSH) which ultimately causes testosterone suppression. Reduction in testosterone is important in treating men with advanced prostate cancer. FDA approved the same as "Firmagon" in December 2008.