KRIBIOLISA Tocilizumab (ACTEMRA) ELISA ? Total Drug

SKU: KBI1022-3

Rs 102,000.00

Enzyme Immunoassay for the estimation of total drug which includes free, bound and partially bound Tocilizumab (ACTEMRA) in serum plasma and cell culture supernatant. Key features: 1. Developed using highly specific monoclonal anti-idiotypic antibodies in a sandwich assay format 2. Validated as per international bioassay validation guidelines 3. Recovery: 80-120% 4. Precision CV <10%


Availability: 3 – 4 Weeks | Pack Size: 1 x 96 wells

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Background: Tocilizumab, also known as atlizumab, is an immunosuppressive drug, mainly for the treatment of rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis, a severe form of arthritis in children. It is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). IL-6 is a pleiotropic cytokine with diverse physiological actions, regulating the immune response, inflammation, bone metabolism, and hematopoiesis. It is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer. IL-6 forms a complex by binding to IL-6 R on the cell membrane, which then combines with gp130, which also resides on the cell membrane, forming a homodimer and giving rise to intracellular signal transduction. Tocilizumab inhibits the induction of biological activity due to IL-6 in cells that have expressed both membrane-bound IL-6R and gp130 molecules, and also inhibits the induction of biological activity due to IL-6/IL-6R complex formation in cells that express gp130 alone. It also exhibits effective blocking of IL-6 signal transduction due to its capacity to dissociate IL-6/IL-6R complexes that have already formed. Intended Use: For Estimation of Tocilizumab (ACTEMRA) in human serum and plasma. Please note the kit has not been optimized to be used for any other animal species. Should you require a specific sera tested, please connect with us at sales@krishgen.com for optimization.

Additional information

Target / Pathway

IL 6 / IL 6R pathway

Active Molecule / Modality

Tocilizumab – IgG1 mAb; blocks IL 6 receptor

Pack Type

1 x 96 wells, break-apart

Species Reactivity

Homo Sapiens (Human)

Sample Type

cell culture supernates and other biological fluids. For tear samples, cell lysates, plasma, pleas connect with us to optimize the kit accordingly., please connect with us to discuss further. Note the kit has been validated using human matrices only. For any other animal matrix, Serum, tissue homogenates

Analyte / Drug

Tocilizumab

Species Cmax Value

Adults with RA (label PK)

Dose & Regimen Reported

8 mg/kg IV q4w (steady-state)

Cmax (value + units)

183 ? 85.6 ug/mL (steady-state peak)

Cmax Source (DOI/URL)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761275s004761449s001lbl.pdf

Sample Dilution

please refer to the most updated IFU enclosed with the kit supplied, Samples are to be diluted 1:1000 with the Sample Diluent provided in the kit. For more specific dilution instructions

Assay Range Cmax Value

0 – 640 ng/ml

Standards Available

0; 10; 20; 40; 80; 160; 320; 640 ng/ml

Calibration Curve

6/8 point; standards available

Sensitivity

5 ng/ml

Interference

Preparations of the known factors were assayed for interference. No significant interference was observed.

Specificity

The assay uses anti idiotypic (humanized) antibody for capture and / or recombinant protein expressed in mamalian cells

Detection Method

Absorbance measured at 450nm, Colorimetric

Conjugate-Enzyme Reaction

Uses stable HRP Enzyme Conjugate with (single component) TMB Chromogenic Substrate for color development.

Shipping Temperature

Shipped at Room Temperature or in gel pack to maintain temperature at 2-8 degrees Celsius

Storage Temperature

if all the wells in the kit are not being used, store the unused wells in the foil pouch containing the desiccant pack, The kit (2-8 Degree Celsius) and its components are to be stored as indicated in the IFU (instructions for use). To ensure quality of your results

ELISA Type

Double Antibody, Sandwich ELISA

ELISA Interpretation

4PL (2nd order) or Cubic Spline Graph. Software (MS Excel) available, on request, Quantitative Results Intepretation, to support interpretation of results.

Shelf Life Available

8 -10 months at time of shipping

Alternate Names / Synonyms

Tocilizumab; ACTEMRA ? Total Drug

Research Area

Immune molecule; Cell Biology; Immunology, Tumor