Enzyme immunoassay for the specific and quantitative determination of free Eculizumab (Soliris) in serum, plasma and cell culture samples.
Contents of Kit
No.
Components
Size
Storage Conditions
1.
Microtiter ELISA Plate
1×12×8
2-8°C
2.
Eculizumab Standard, Concentrate (6.4 μg/ml)
1 × 120 μL
2-8°C
3.
Anti-Eculizumab Biotin (100×)
1 × 120 μL
2-8°C
4.
Streptavidin-enzyme Conjugate, Concentrate (100×)
1 × 120 μL
2-8°C
5.
Dilution Buffer, Ready to use
1 × 50 mL
2-8°C
6.
Substrate Solution, Ready to use
2 × 6 mL
2-8°C
7.
Stop Solution, Ready to use
1 × 7 mL
2-8°C
8.
Wash Buffer, Concentrate (20×)
1 × 50 mL
2-8°C
Storage
The kit is shipped at ambient temperature and should be stored at 2-8°C. Keep away from heat or direct sun light. The storage and stability of specimen and prepared reagents is stated in the corresponding chapters. The microtiter strips 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 <20%
Detection Range
2.6 - 640 ng/mL
Sensitivity
0.218 ng/mL
Standard Curve
The following figures demonstrate typical Eculizumab ELISA results. One should use the data below for reference only. This data should not be used to interpret actual results.
General Notes
Enzyme immunoassay for the specific and quantitative determination of free Eculizumab (Soliris) in serum, plasma and cell culture samples.
Citations
Publication ()
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Background
The Eculizumab ELISA Kit is an innovative and cutting-edge product that plays a crucial role in the field of biotechnology and medical research. Eculizumab, a monoclonal antibody, is a highly effective therapeutic agent used in the treatment of various disorders, including paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Eculizumab was the first drug approved for each of its uses, and its approval was granted based on small clinical trials. This ELISA kit is specifically designed to quantify the levels of Eculizumab in biological samples, providing researchers and clinicians with a powerful tool to monitor and optimize treatment strategies.
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References
Development and validation of an enzyme-linked immunosorbent assay to measure free eculizumab concentration in serum
Aim: Eculizumab is a monoclonal antibody toward C5 fraction of the complement system. It is approved to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. To perform pharmacokinetic studies and therapeutic drug monitoring, a validated assay is required. Materials & methods: An indirect ELISA with recombinant human C5 sensitized microtiter plates were developed. Results: The assay allows the measurement of free eculizumab concentration in human serum. The LOD, LLOQ and ULOQ were 0.091, 0.25 and 82.35 mg/l, respectively. The assay meets EMA and US FDA guidelines criteria for the validation of a ligand-binding assay. Conclusion: This method is validated and can be used in PK and PK-PD studies as well as to perform therapeutic drug monitoring of free eculizumab.
COA
Publication 
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