Somru Bioscience

Pegylated Proteins ADA

$0.00

Catalog #: SB-06-016

SKU: SB-06-016 Category: Tag:
Category

Immunogenicity

Species

Size

1 pack ( 2 x 96 wells)

Data Sheet

Polyetheylene Glycol (PEG) ADA ELISA

Catalogue Number: SB-06-016

For the quantitative determination of Polyetheylene Glycol 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® Polyetheylene Glycol (PEG) ADA ELISA kit is a sandwich assay for the determination of antibodies against PEG in serum and plasma samples. Our ELISA-based kits combine a fast, user-friendly format with a sensitive and specific assay.
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 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.
Positive control Rabbit anti-PEG polyclonal antibody fortified in human serum. Check lot specific Certificate of Analysis (CofA) for details.
Precision The precision was determined by analyzing samples prepared at 400 ng/mL in 6 replicates on 6 different occasions. Intra-assay precision (coefficient of variation(CV)) ranges from 4% CV to 6%CV. Inter-assay mean precision precision was at 7%CV.
Sensitivity The detection limit is 35-217 ng/mL depending on the positive control used.
Drug Tolerance The drug tolerance is up to 8 µg/mL.
Sample Pre-treatment An acid dissociation step is recommended to improve drug tolerance and the detection of ADAs in biological samples. Please contact our technical service team at tec@somrubioscience.com.
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.
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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