Data Sheet
Pegfilgrastim (Neulasta®) – PK ELISA
Catalogue Number: SB-07-044
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 ELISA assay employs the quantitative double antibody sandwich enzyme immunoassay technique using two monoclonal antibodies. A monoclonal antibody specific to filgastim is used as capture antibody and another antibody specific to polythelene glycol is used as detection antibody. This combination of antibodies allows for measurement of whole pegfilgrastim molecule. |
| 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 pegfilgrastim in human serum or plasma. |
| Precision | The precision was determined by analyzing samples prepared at 800 pg/mL in 6 replicates on 6 different occasions. Intra-assay precision (coefficient of variation(CV)) ranges from 4% to 8%. Inter-assay precision was at 7%. |
| Accuracy | The accuracy was determined by analyzing three levels of quality control samples in 6 replicates on 6 different occasions. Mean %bias was less than 9%. |
| Total Error | Total Error (TE) was calculated by adding the mean %bias with inter-assay variability (%CV). The TE was found to be less than 16%. |
| Selectivity/ Recovery | The recovery of pegfilgrastim was evaluated by fortifying 800 pg/mL of pegfilgrastim in various matrices. The recovery ranged from 98% to 118%. |
| Sensitivity | The limit of detection is 156 pg/mL. |
| Dilutional Linearity | Dilutional linearity was established up to a dilution of 200 fold. |
| 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
