Description
Enzyme immunoassay for the quantitative and qualitative determination of free antibodies to Golimumab (Simponi®) in serum and plasma. The solid phase (MTP) is coated by the drug Golimumab. Due to the assay design this test measures the free antibodies which are not bound to Golimumab. Results could be expressed in both qualitative and quantitative manner (nanogram per mililiter-ng/mL). Required Volume (µL): 50 Incubation Time (min): 135 Sample: Serum/Plasma Plate Size: 96 Tests Results in: Qualitative & Quantitative (ng/mL) Shelf Life (years): 2 Intended Use: This kit has been developed for the detection of anti-drug antibodies in research and diagnostic uses. It is suitable for Therapeutical Drug Monitoring (TDM) purposes. Simponi® is a trademark of Janssen Biotech, Inc./Merck & Co.
Specifications
- Catalog no.
- BB107
- Analyte
- Golimumab
- Assay type
- Anti-drug antibody (ADA) ELISA
- Sample type
- Serum/Plasma
- Sensitivity
- Detection Threshold 2 ng/mL
- Format
- ELISA (enzyme immunoassay)
- Tests per kit
- 96 Tests
- Regulatory
- RuO - Research Use Only
Essay characteristics
ANALYTICAL SENSITIVITY-THRESHOLD VALUE
The Detection Threshold for the assay is 2 ng/mL.
The assay sensitivity for undiluted clinical samples corresponds to 4 ng/mL
Because the serum or plasma samples are instructed to be diluted at two-fold (1:2) before starting the assay.
ASSAY RANGE
For anti-Golimumab antibodies in serum and plasma, the method has been demonstrated to be highly (>0.99 %) linear from 0 to 40 ng/mL.
ASSAY PRECISION
Intra-assay CV:
|
Mean |
CV (%) |
|---|---|
| 40 | <10 |
| 20 | <10 |
| 10 |
<10 |
Inter-assay CV: <10%.
ASSAY RECOVERY
Recovery rate was found to be 85-115% using native serum and plasma samples spiked with exogenous Anti Drug Antibody (ADA) positive samples.
AUTOMATION
The ImmunoGuide ADA ELISA is suitable also for being used by an automated ELISA processor.
References
1. Gelfer G, Perry L, Deodhar A. Golimumab for the treatment of axial spondyloarthritis. Expert Rev Clin Immunol. 2015; 2:1-10.
2. Lichtenstein GR, Hanauer SB, Sandborn WJ. Emerging Treatment Options in Mild to Moderate Ulcerative Colitis. Gastroenterol Hepatol (N Y). 2015;11(3 Suppl 1):1-16.
3. Emery P, Fleischmann RM, Strusberg I, Durez P, Nash P, Amante E, Churchill M, Park W, Pons-Estel B, Han C, Gathany TA, Xu S, Zhou Y, Leu JH, Hsia EC. Efficacy and safety of subcutaneous golimumab in methotrexate-naïve patients with rheumatoid arthritis: 5-year results of the GO-BEFORE trial. Arthritis Care Res (Hoboken). 2015 Oct 16. doi: 10.1002/acr.22759
4. Lee WK, Kim GW, Cho HH, Kim WJ, Mun JH, Song M, Kim HS, Ko HC, Kim MB, Kim BS. Erythrodermic Psoriasis Treated with Golimumab: A Case Report. Ann Dermatol. 2015 Aug;27(4):446-9.
5. Brady BL, Tkacz JP, Lofland J, Meyer R, Bolge SC. Prescribing Patterns of Intravenous Golimumab for Rheumatoid Arthritis. Clin Ther. 2015;37(9):2028-36.
6. Yonemoto Y, Okamura K, Takeuchi K, Ayabe K, Kaneko T, Matsushita M, Tamura Y, Iso T, Okura C, Otsuka K, Inoue H, Takagishi K. Comparison of golimumab 100-mg monotherapy to golimumab 50 mg plus methotrexate in patients with rheumatoid arthritis: Results from a multicenter, cohort study. Mod Rheumatol. 2015; 3:1-5.
7. Abreu MT Commentary: Golimumab in Moderate-to-Severe Ulcerative Colitis. Gastroenterol Hepatol (N Y). 2014;10(7):455-6.
8. Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Colombel JF, Reinisch W, Gibson PR, Collins J, Järnerot G, Hibi T, Rutgeerts P; PURSUIT-SC Study Group. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146(1):85-95.
9. Thorlund K, Druyts E, Toor K, Mills EJ. Comparative efficacy of golimumab, infliximab, and adalimumab for moderately to severely active ulcerative colitis: a network meta-analysis accounting for differences in trial designs. Expert Rev Gastroenterol Hepatol. 2015;9(5):693-700.
10. Kanbe K, Chiba J, Inoue Y, Taguchi M, Yabuki A. Predictive factors related to the efficacy of golimumab in patients with rheumatoid arthritis. Clin Med Insights Arthritis Musculoskelet Disord. 2015;8:25-32.
11. McCarty DJ. Golimumab intravenous infusion for the treatment of rheumatoid arthritis. Nurse Pract. 2015;40(3):15-8.
12. Smolen JS, Kay J, Doyle M, Landewé R, Matteson EL, Gaylis N, Wollenhaupt J, Murphy FT, Xu S, Zhou Y, Hsia EC. Golimumab in patients with active rheumatoid arthritis after treatment with tumor necrosis factor α inhibitors: findings with up to five years of treatment in the multicenter, randomized, double-blind, placebo-controlled, phase 3 GO-AFTER study. Arthritis Res Ther. 2015 Jan 22;17:14. doi: 10.1186/s13075-015-0516-6.