Somru Bioscience

Adalimumab (Humira®) ADA

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Catalog #: SB-06-024

SKU: SB-06-024 Category: Tag:
Category

Immunogenicity

Species

Size

1 pack ( 2 x 96 wells)

Data Sheet

Adalimumab (Humira®) – ADA ELISA

Catalogue Number: SB-06-024

For the quantitative determination of Adalimumab in human serum and plasma

Notice: This product specification data sheet is for information purposes only. Please contact tec@somrubioscience.com for up to date information.

Product Specifications Data Sheet

Detection Method Colorimetric; absorbance at 450 nm with a reference at 650nm.
Storage Kit ships at 2 to 8°C. Multiple storage temperatures upon arrival.
Positive Control Chicken anti-adalimumab.
Sensitivity Detection limit of 84 ng/mL.
Drug Tolerance Tolerance up to 7.3 µg/mL.
Sample Pre-Treatment Drug tolerance can be improved with acid dissociation. For further details please contact tec@somrubioscience.com.
Precision Intra-assay precision ranges from 3 to 7%. Inter-assay mean precision is 12%. Determined by analysis of samples at 500 ng/mL in 6 replicates, on 6 different occasions.
Rheumatoid Factor (RF) Interference If high levels are RF are expected, a sample pre-treatment step may be incorporated into the assay. For further details please contact tec@somrubioscience.com.
Interpretation of Results Results are reported as positive or negative relative to a pre-determined cutpoint. To determine the cutpoint, run 4-10 negative controls and calculate their mean, then add 2* standard deviations to the calculated mean.
Statistical Cut Point We strongly recommend each lab develop their own statistical cutpoint in the appropriate study population using methodologies as described by G. Shankar, et al. (2008). (Recommendations for the Validation of Immunoassays Used for Detection of Host Antibodies Against Biotechnology Products. J. Pharmaceutical and Biomedical Analysis 48:1267–1281). For further details please contact tec@somrubioscience.com.
Safety Warnings and Precautions All reagents and samples should be handled as if potentially hazardous and infectious. It is recommended that all kit reagents are handled by trained laboratory staff and are used in accordance with GLP.

 

Notice: Somru® ELISA kits are custom-made to order. Each kit lot is tested to ensure that it meets specifications before shipment. Minor adjustments to the preparation of reagents may occur due to lot-to-lot variation. Please always refer to the product sheet enclosed with each kit before performing each experiment.

FOR RESEARCH USE ONLY

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