Data Sheet
Glargine(Lantus®) PK ELISA
Catalogue Number: SB-07-013
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 solid phase two-site enzyme immunoassay. The assay is designed to measure glargine with high specificity and enhanced sensitivity in serum or plasma. | ||||||||||||
| 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 glargine in human plasma or serum. | ||||||||||||
| 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 6%. Inter-assay precision was at 9%. | ||||||||||||
| Accuracy/ Recovery | 20 μU/mL of glargine was fortified in 10 lots of human serum. Recovery ranges are from 91-103% with an average recovery of 94%. | ||||||||||||
| 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 15%. | ||||||||||||
| Sensitivity | The limit of detection is 4.3 μU/mL. | ||||||||||||
| Dilutional Linearity | Not tested. The assay range of 4.3 μU/mL – 200 μU/mL is sufficient to measure clinical and pre-clinical samples. | ||||||||||||
| Hook Effect | No hook effect was observed up to 4000 μU/mL of glargine. | ||||||||||||
| Cross-reactivity |
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| Sample Pre-treatment (ADA Interference) | If a high level of anti-glargine antibody is expected to be present in test samples, an acid dissociation step may be incorporated to minimize the impact of these antibodies in glargine quantitation. Please contact our technical service team at tec@somrubioscience.com. |
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
