Data Sheet
Trastuzumab (Herceptin®) – PK ELISA
Catalogue Number: SB-07-035
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 Trastuzumab ELISA kit is designed to measure trastuzumab with high specificity and enhanced sensitivity in buffer or biological matrices. This user-friendly assay design utilizes trastuzumab specific anti-idiotype monoclonal antibody to capture trastuzumab to the plate and trastuzumab 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. QCs are prepared by fortifying trastuzumab 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 8% to 11%. Inter-assay precision was at 9%. |
| 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 16%. |
| Selectivity Recovery | Selectivity of the assay was evaluated by spiking 10 individual serum lots with 1000 ng/ml of trastuzumab. The recovery ranges from 97% to 107%. The mean recovery was 104%. |
| Sensitivity | The limit of detection is 63 ng/mL. |
| Dilutional Linearity | Dilutional linearity was established up to 1000 fold. |
| Hook Effect | No hook effect was observed up to 300 µg/mL of trastuzumab. |
| 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
