Data Sheet
Cetuximab (Erbitux®) – PK ELISA
Catalogue Number: SB-07-015
For the quantitative determination of Cetuximab 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® Cetuximab ELISA kit is designed to measure cetuximab with high specificity and enhanced sensitivity in serum or plasma. This user-friendly assay design utilizes cetuximab specific monoclonal antibody to capture cetuximab to the plate and cetuximab 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. |
| 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. |
| Quality Control Samples (QCs) | Three levels of QCs are included for custom GLP kits for an additional cost. Three levels of QCs (900 ng/mL, 4000 ng/mL and 7500 ng/mL) are included with the kit. QCs are prepared by fortifying cetuximab in human serum. |
| Precision | The precision was determined by analyzing samples prepared at 4000 ng/mL in 6 replicates on 6 different occasions. Intra-assay precision (coefficient of variation(CV)) ranges from 4% to 9%. Inter-assay precision was at 10%. |
| 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 7%. |
|
Total Error |
Total Error (TE) was calculated by adding the mean %bias with inter-assay variability (%CV). The TE was found to be 17%. |
| Selectivity/ Recovery | Selectivity of the assay was evaluated by spiking 10 individual serum lots with 1000 ng/ml of Cetuximab. The recovery ranges from -5% to 9%. The mean recovery was 5%. |
| 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 400 µg/mL of cetuximab. |
| Sample Pre-treatment (ADA Interference)
|
If a high level of anti-cetuximab antibody is expected to be present in test samples, an acid dissociation step may be incorporated to minimize the impact of these antibodies in cetuximab quantitation. Please contact our technical service team at tec@somrubioscience.com. |
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
