Catalog No.
KDB94402
Description
PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human TNFa has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Certolizumab in the sample competitively binds to the pre-coated protein with biotin-labeled Certolizumab. After washing away any unbound substances, Streptavidin-HRP is added to the wells. Following a wash to remove any unbound enzyme reagent, a substrate solution is added to the wells and color develops in inversely proportion to the amount of Certolizumab bound in the initial step. The color development is stopped and the intensity of the color is measured.
Applications
Used for the quantitative determination of Certolizumab concentration in serum and plasma.
Detection method
Colorimetric
Sample type
Plasma, Serum
Assay type
Quantitative
Range
468.75 - 30,000 ng/mL
Sensitivity
329.66 ng/mL
Precision
Intra-Assay Precision (Precision within an assay): <20%
Three samples of known concentration were tested sixteen times on one plate to assess intra-assay precision.
Inter-Assay Precision (Precision between assays): <20%
Three samples of known concentration were tested in twenty four separate assays to assess inter-assay precision.
|
Intra-Assay Precision |
Inter-Assay Precision |
||||
Sample |
1 |
2 |
3 |
1 |
2 |
3 |
n |
16 |
16 |
16 |
24 |
24 |
24 |
Mean (ng/mL) |
19649.7 |
4203.7 |
1503.8 |
16500.1 |
3681.2 |
1240.7 |
Standard deviation |
2286.2 |
360.4 |
128.4 |
2008.9 |
422.3 |
95.4 |
CV (%) |
11.6 |
8.6 |
8.5 |
12.2 |
11.5 |
7.7 |
Recovery
80-120%
Shipping
2-8 ℃
Stability and Storage
When the kit was stored at the recommended temperature for 6 months, the signal intensity decreased by less than 20%. For unopened kits, if you want to prolong the storage time, please store the Standard, Detection A, Detection B and Microplate at - 20 ℃, the rest reagents should be store at 4℃.
Alternative Names
CDP870, PHA-738144, Certolizumab pegol, CAS: 428863-50-7
Background
Certolizumab pegol is a recombinant, humanized F(ab)’ fragment of an antibody conjugated to polyethylene glycol to enhance its plasma half-life. It does not contain an FC region and therefore does not cause antibody-dependent cell-mediated or complement-dependent cytotoxicity as described for infliximab, etanercept, and adalimumab. Another difference is that certolizumab pegol preferentially penetrates inflamed tissue compared to noninflamed tissue, and does so to a greater extent than adalimumab or infliximab. It is directed against soluble and membrane-associated human TNF-α and was approved for the treatment of Crohn’s disease that does not respond to conventional therapy in 2008 and for RA in 2009.