Data Sheet
Trastuzumab (Herceptin®) – ADA ELISA
Catalogue Number: SB-06-035
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 for the qualitative determination of antibodies to Trastuzumab in serum and plasma. Our ELISA-based kits combine a fast, user-friendly format with a sensitive and specific assay. This assay is capable of detecting all isotypes of anti-Trastuzumab antibodies. |
| Detection Method | Colorimetric; absorbance at 450 nm with reference absorbance at 650 nm. |
| Storage | Store the unopened kit at 2-8 °C. |
| Positive control | Chicken anti-Trastuzumab antibodies fortified in human serum. Check lot specific Certificate of Analysis (CofA) for details. |
| Precision | The precision was determined by analyzing samples prepared at 500 ng/mL in 6 replicates on 6 different occasions. Intra-assay precision (coefficient of variation(CV)) ranges from 3% to 13%. Inter-assay mean precision was at 9%. |
| Sensitivity | The detection limit is 45 ng/mL |
| Drug Tolerance | The drug tolerance is up to 3.3 µg/mL. |
| Sample Pre-treatment | An acid dissociation step is recommended to improve drug tolerance and the detection of ADAs in biological samples. For further details, please contact our technical service team at tec@somrubioscience.com. |
| Sample Pre-treatment (RF Interference) | If high levels of rheumatoid factor (RF) is expected to be present in test samples, a sample pre-treatment step may be incorporated to minimize of the impact of these RF in anti-Trastuzumab antibody detection. Please contact our technical service team at tec@somrubioscience.com for details. |
| Interpretation of results | The results are reported as positive or negative relative to a pre-determined cutpoint. The cutpoint may be determined in each plate by running 4-10 negative controls. The cutpoint is calculated by calculating the mean of the negative controls and by adding 2*standard deviations to the calculated mean. |
| Safety Warnings and Precautions | All chemicals and biological samples should be considered potentially hazardous and infectious. 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. |
| 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). Please contact our technical service team at tec@somrubioscience.com for details. |
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
