Anti-Tocilizumab ELISA Kit

Sample

Serum, plasma and cell culture supernatant

Intended Use

The Anti-Tocilizumab ELISA is used as an analytical tool for quantitative determination of AntiTocilizumab in serum, plasma and cell culture supernatant.

Storage

1. All reagents should be stored at 2°C to 8°C for stability.
2. All the reagents and wash solutions should be used within 12 months from manufacturing date.
3. Before using, bring all components to room temperature (18-25°C). Upon assay completion ensure all components of the kit are returned to appropriate storage conditions.
4. The Substrate is light-sensitive and should be protected from direct sunlight or UV sources.

Precision

Precision is defined as the percent coefficient of variation (%CV) i.e. standard deviation divided by the mean and multiplied by 100. Assay precision was determined by both intra (n=5 assays) and inter assay (n=5 assays) reproducibility on two pools with low (10ng/ml), medium (80ng/ml) and high (640ng/ml) concentrations. While actual precision may vary from laboratory to laboratory and technician to technician, it is recommended that all operators achieve precision below these design goals before reporting results.

Detection Limit

It is defined as the lowest detectable concentration corresponding to a signal of Mean of '0' standard plus 2* SD.
10 replicates of '0' standards were evaluated and the LOD was found to be less than 10 ng/ml.

General Description

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). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer. It was developed by Hoffmann–La Roche and Chugai. Anti-Drug Antibodies (ADA) may induce unwanted side effects in biopharmaceuticals. Hence, ADA has been subjected to increase in scrutiny by the regulatory authorities using immunogenicity safety studies. ADA has been observed in pre-clinical and clinical studies, resulting in significant changes in toxicology, pharmacokinetics and efficacy. These effects result from the generation of drug-induced (neutralizing) autoantibodies against Tocilizumab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects antibodies for Anti-Tocilizumab and may be used for monitoring immunogenicity.