Somru Bioscience

Bevacizumab (Avastin®) ADA

$0.00

Catalog #: SB-06-041

SKU: SB-06-041 Category: Tag:
Category

Immunogenicity

Species

Size

1 pack ( 2 x 96 wells)

Data Sheet

Bevacizumab (Avastin®) – ADA ELISA

Catalogue Number: SB-06-041

For the quantitative determination of Bevacizumab 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® Bevacizumab ELISA kit is designed for the qualitative determination of antibodies to bevacizumab 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-bevacizumab 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-bevacizumab 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 6% to 12%. Inter-assay mean precision was at 15%.
Sensitivity The detection limit is 63 ng/mL
Drug Tolerance The drug tolerance is up to 4.3 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-bevacizumab 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

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