Data Sheet
Etanercept (Enbrel®) PK ELISA
Catalogue Number: SB-07-012
For the quantitative determination of Etanercept 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® Etanercept ELISA kit is designed to measure etanercept with high specificity and enhanced sensitivity in serum or plasma. This user-friendly assay design utilizes a pair of antibodies that allows the detection of the whole etanercept molecule in biological matrices. |
| 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 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. |
| Quality Control Samples (QCs) | Three levels of QCs are included for custom GLP kits for an additional cost. QCs are prepared by fortifying etanercept in human serum or plasma. |
| Precision | The precision was determined by analyzing samples prepared at 800 ng/mL in 6 replicates on 6 different occasions. Intra-assay precision (coefficient of variation(CV)) ranges from 3% to 9%. Inter-assay precision was at 13%. |
| 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 16%. |
| 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 24%. |
| Sensitivity | The detection limit is 64 ng/mL when the regular protocol is used.
The detection limit is 19 ng/mL when the high sensitivity protocol is used. |
| Dilutional Linearity | Dilutional linearity was established up to 10,000 fold. Samples can be diluted up to 10,000 fold without any significant impact on the recovery of the samples. |
| Hook Effect | No hook effect was observed up to 90,000 ng/mL of etanercept. |
| Specificity | The following factors prepared at 200 ng/mL were assayed and exhibited no cross-reactivity or interference:
Recombinant human: sTNF- alpha, TNF-beta, sTNF RI, sTNF RII |
| Sample Pre-treatment (RF Interference) | If a high level of rheumatoid factor (RF) is expected to be present in test samples, a sample pre-treatment step using Somru® Indigo buffer may be incorporated to minimize of the impact of these RF in etanercept quantitation. 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
