Sample
Serum, Plasma (EDTA, Heparin)
Intended Use
Enzyme immunoassay for determination of quantitative antibodies to Certolizumab in serum and plasma samples.
Storage
The kit is shipped at ambient temperature (10-30°C) and should be stored at 2-8°C for long term storage. Keep away from heat or direct sunlight. The strips of microtiter plate are stable up to the expiry date of the kit in the broken, but tightly closed bag when stored at 2-8°C.
Precision
Intra-assay and inter-assay CVs < 30%
Sensitivity
The lowest detectable level (Lowest detection limit, LOD) that can be distinguished from the zero standard is 5 ng/mL
Functional sensitivity (Limit of quantification-LOQ): 10 ng/mL
General Description
Certolizumab pegol is a pegylated monoclonal antibody against the tumour necrosis factoralpha (TNF-alpha). It is formed with a humanized Fab fragment of 50 kDa, from an IgG 1 isotype, fused to a 40 kDa polyethylene glycol moiety replacing the Fc antibody region. The absence of the Fc region was ideated to prevent complement fixation and antibodymediated cytotoxicity as well as to markedly increase its half-life. Certolizumab does not require glycosylation for active function and hence, its production is significantly more affordable when compared to other existing TNF-alpha therapies as it can be done directly in bacterial hosts such as E. coli.
Citations
Publication ()
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