Data Sheet
Glargine (Lantus®) ADA ELISA
Catalogue Number: SB-06-013
For the quantitative determination of Glargine 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® Glargine ELISA kit is a dual detection sandwich assay for the determination of antibodies against glargine in serum and plasma samples. Assay employs acid charcoal pre-treatment of samples to improve drug tolerance. The assay is designed to detect human IgGs against glargine. The assay can be modified to detect other isotypes of immunoglobulins. |
| 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-glargine 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 4% to 14%. Inter-assay mean precision was at 15%. |
| Sensitivity | The detection limit is 67 – 88 ng/mL depending on the positive control used. |
| Drug Tolerance | The drug tolerance is up to 100 ng/mL. |
| Sample Pre-treatment | An acid charcoal treatment to remove insulin and glargine from sample highly 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. |
| 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
