Data Sheet
Adalimumab (Humira®) PK ELISA
Catalogue Number: SB-07-024
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
| About | The Somru® Adalimumab ELISA kit is designed to measure adalimumab with high specificity and enhanced sensitivity in serum or plasma. This user-friendly assay design utilizes adalimumab specific anti-idiotype monoclonal antibody to capture adalimumab to the plate and adalimumab specific polyclonal antibody for detection. |
| Detection method | Colorimetric; absorbance at 450 nm with reference absorbance at 650 nm. |
| Storage | Store the unopened kit at 2-8 °C. |
| Quality Control Samples (QCs) | Three levels of QCs are included for custom GLP kits for an additional cost. Custom GLP kits includes three levels of QCs (900 ng/mL, 4000 ng/mL and 7500 ng/mL). QCs are prepared by fortifying adalimumab in human serum. |
| Precision | The precision was determined by analyzing samples prepared at 1000 ng/mL in 6 replicates on 6 different occasions. Intra-assay precision (coefficient of variation(CV)) ranges from 5% to 10%. Inter-assay precision was at 11%. |
| Accuracy | The accuracy was determined by analyzing three levels of quality control samples in 6 replicates on 6 different occasions. Mean absolute %bias was less than 8%. |
| Total Error | Total Error (TE) was calculated by adding the mean %bias with inter-assay variability (%CV). The TE was found to be 19%. |
| Selectivity/ Recovery | Selectivity of the assay was evaluated by spiking 10 individual serum lots with 1000 ng/ml of Adalimumab. The recovery ranges from 85% to 109%. The mean recovery was 95%. |
| Sensitivity | The limit of detection is 156 ng/mL. |
| Dilutional Linearity | Dilutional linearity was established up to 40 fold. |
| Hook Effect | No hook effect was observed up to 500 µg/mL of Adalimumab. |
| Sample Pre-treatment (ADA Interference) | If a high level of anti-Adalimumab antibody is expected to be present in test samples, an acid dissociation step may be incorporated to minimize the impact of these antibodies in Adalimumab quantitation. Please contact our technical service team at tec@somrubioscience.com. |
| Safety Warnings and Precautions | All chemicals should be considered potentially hazardous. We recommend that this product and its components be handled by those trained in laboratory techniques and be used according to the principles of Good Laboratory Practice. |
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
