Description
Enzyme immunoassay for the quantitative and qualitative determination of free antibodies to Adalimumab (Humira®) in serum and plasma. The solid phase (MTP) is coated by the drug Adalimumab. Due to the assay design this test measures the free antibodies which are not bound to Adalimumab. 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 Package Size: 96 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. Humira® is trademark of Abbott Laboratories.
Specifications
- Catalog no.
- BB103
- Analyte
- Adalimumab
- Assay type
- Anti-drug antibody (ADA) ELISA
- Sample type
- Serum, Plasma
- Sensitivity
- Detection Threshold 2,5 ng/mL
- Format
- ELISA (enzyme immunoassay)
- Tests per kit
- 96
- Regulatory
- RuO - Research Use Only
Essay characteristics
ANALYTICAL SENSITIVITY-THRESHOLD VALUE
The Detection Threshold for the assay is 2,5 ng/mL.
The assay sensitivity for undiluted clinical samples corresponds to 5 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-Adalimumab antibodies in serum and plasma, the method has been demonstrated to be highly (>0.99 %) linear from 0 to 150 ng/mL.
ASSAY PRECISION
Intra-assay CV:
|
Mean |
CV (%) |
|---|---|
| 150 | <10 |
| 50 | <10 |
| 15 |
<10 |
Inter-assay CV: <10%.
ASSAY RECOVERY
Recovery rate was found to be 85-110% 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
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8. Bodini G, Savarino V, Peyrin-Biroulet L, de Cassan C, Dulbecco P, Baldissarro I, Fazio V, Giambruno E, Savarino E. Low serum trough levels are associated with post-surgical recurrence in Crohn's disease patients undergoing prophylaxis with adalimumab. Dig Liver Dis. 2014;46(11):1043-6.
9. Tanida S, Mizoshita T, Nishie H, Ozeki K, Katano T, Kubota E, Kataoka H, Kamiya T, Joh T. Combination Therapy With Adalimumab Plus Intensive Granulocyte and Monocyte Adsorptive Apheresis in Patients With Refractory Ulcerative Colitis. J Clin Med Res. 2015;7(11):884-9.
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