Data Sheet
Pegfilgrastim (Neulasta®) – ADA ELISA
Catalogue Number: SB-06-044
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® Pegfilgrastim ADA ELISA kit is a direct sandwich assay for the determination of antibodies against pegfilgrastim in serum and plasma samples. Assay is capable of detecting IgG, IgM and IgA antibodies specific to pegfilgrastim. |
| Detection Method | Colorimetric; Absorbance at 450 nm with reference absorbance at 650 nm. |
| Storage | Store the unopened kit at 2-8 °C. |
| Positive control | Rabbit /Rat anti-pegfilgrastim antibodies fortified in human serum. Check lot specific Certificate of Analysis (CofA) for details. |
| Precision
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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 9% CV to 18%CV. Inter-assay mean precision precision was at 16%CV. |
| Sensitivity | The detection limit is 143 – 208 ng/mL depending on the positive control used. |
| Drug Tolerance | No significant interference was observed for up to 200 ng/mL of pegfilgrastim. |
| Sample Pre-treatment | An acid charcoal treatment to remove excess pegfilgrastim from sample is highly recommended to improve drug tolerance and improve the detection of ADAs in biological samples. Please contact our technical service team at tec@somrubioscience.com. |
| Interpretation of results | The results are interpreted as positive or negative relative to a pre-determined cut point. The cut point may be determined in each plate by running 4-10 negative controls. The cut point 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 cut point 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
