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CERTOLIZUMAB PEGOL ELISA (MAB-BASED)
Enzyme immunoassay for the specific and quantitative determination of free Certolizumab Pegol (Cimzia®) in serum and plasma.
The solid phase (MTP) is coated by a highly specific monoclonal antibody directed against Certolizumab Pegol. Therefore any cross reactivity to the other therapeutical monoclonal antibodies is excluded.
| Required Volume (µL) | 10 |
| Incubation Time (min) | 165 |
| Sample | Serum or Plasma |
| Plate Size | 96 Tests |
| Standard Range (µg/mL, 500x) | 0-100 |
| Detection Limit (ng/mL) | 5 |
| Spike Recovery (%) | >95 |
| Shelf Life (years) | 2 |
Intended Use: This kit has been developed for the measurement of drug levels in research and diagnostic uses. It is suitable for Therapeutical Drug Monitoring (TDM) purposes.
Cimzia® is a trademark of UCB.
ESSAY CHARACTERISTICS
SPECIFICITY
There is no cross reaction with any other proteins present in native human serum. A screening test was performed with 48 different native human sera at a dilution of 1:500. All produced OD450/620 nm values (ranged from 0.018 to 0.022) less than the mean OD (0.151) of the diluted standard D (6 ng/mL). In addition, binding of Certolizumab pegol is inhibited by recombinant human tumor necrosis factor alpha (rhTNFα) in a concentration dependent manner. Therefore, the ImmunoGuide Certolizumab pegol ELISA (mAb-based) measures the biologically active free form of Certolizumab pegol, i.e. not pre-occupied by TNFα. No cross reaction was observed with sera spiked with the other therapeutic antibodies including Infliximab, Etanercept, Adalimumab, Golimumab, Remsima, Tocilizumab, Trastuzumab and Rituximab tested at concentration of 100 µg/mL. All produced mean OD450/620 nm values less than 0.040.
SENSITIVITY
The lowest detectable concentration level in the well that can be clearly distinguished from the zero standard is 2 ng/mL (zero standa rd +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 2 ng/mL, and corresponding to the detection limit (limit of quantification) of 1 µg/mL for undiluted clinical samples because the serum or plasma samples are instructed to be diluted at 1:500 before starting the assay.
PRECISION
Intra-assay CV: <10%.
Inter-assay CV: <10%.
RECOVERY
Recovery rate was found to be >95% with native human serum and plasma samples when spiked with exogenous Certolizumab pegol at 100, 30, 10 and 3 μg/mL.
AUTOMATION
The ImmunoGuide Certolizumab pegol ELISA (mAb-based) is suitable also for being used by an automated ELISA processor.
REFERENCES
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13. Lee YH, Bae SC. Efficacy and safety of methotrexate plus certolizumab pegol or placebo in active rheumatoid arthritis : Meta-analysis of randomized controlled trials. Z Rheumatol 2016 Jun 16. DOI10.1007/s00393-016-0133-z
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17. Mease P, Deodhar A, Fleischmann R, Wollenhaupt J, Gladman D, Leszczyński P, Vitek P, Turkiewicz A, Khraishi M, FitzGerald O, Landewé R, de Longueville M, Hoepken B, Peterson L, van der Heijde D. Effect of certolizumab pegol over 96 weeks in patients with psoriatic arthritis with and without prior antitumour necrosis factor exposure. RMD Open. 2015 Jun 25;1(1):e000119. doi: 10.1136/rmdopen-2015-000119. eCollection 2015
18. Takeuchi T, Yamamoto K, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, Watanabe A, Origasa H, Kobayashi M, Shoji T, Togo O, Miyasaka N, Koike T. Post-hoc analysis showing better clinical response with the loading dose of certolizumab pegol in Japanese patients with active rheumatoid arthritis. Mod Rheumatol. 2016; 26(4): 473-80.
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INSTRUCTIONS FOR USE
SAFETY DATA SHEET
BATCH/LOT INFORMATION