The iLiteTM Technology
Neutekbio's iLiteTM technology is based upon conventional gene-reporter assay format that has been modified and adapted for commercial applications in the diagnostic and clinical research market segments.
All of Neutekbio's products, whether for use in diagnostic medicine or clinical research, have been manufactured under strict adherence to ISO 13485 quality systems and subjected to rigorous quality analysis and control.
Through these procedures an important but variable research tool has been converted into a precise, sensitive and reproducible assay format that is amenable to validation and use in disease diagnosis, pre-clinical and clinical investigations and cGMP manufacturing processes.
Specificity
Cytokines are, by definition, relatively inert in a biological sense and exert their measurable bioactivity through the very specific interaction with their cell surface receptors. The high affinity constant of this binding determines the specificity of the cell's response; hence, in the complex composition of biological fluids, a given receptor will only bind to a defined cytokine.
The ultimate specificity of the cytokine/receptor interaction is as great as, or greater than, the binding of antigen to a specific antibody.
Bioactivity
iLiteTM assays measure protein bioactivity and not simply protein mass which is a significant advantage over traditional ELISA methods.Sensitivity
The binding of cytokine to its receptor initiates an intracellular biosynthetic cascade of signal transduction reactions that results in the activation of a collection of cytokine sensitive genes.
This collection of "induced" genes are the candidates for the "reporter gene" function and a careful selection of the proper gene is critical for both specificity and sensitivity of the assay. Genetic engineering techniques are then used to replace the endogenous gene with the gene for enzyme firefly luciferase and modifications are made to maximize reporter gene expression.
Reproducibility and Repeatability
Critical to the use of a "gene reporter" format in diagnostic and clinical medicine and cGMP manufacturing is reliability and minimal batch to batch variation. Neutekbio's iLiteTM technology is designed to assure the investigator that each assay will perform in a reliable and repeatable manner. The reporter cells have been selected for a high level of active cytokine receptor protein and the cells are grown in a precise and defined manner to insure that the number of receptor molecules per cell is constant.
The cells are then treated in a proprietary manner to render the population "cell proliferation deficient" and these division arrested cultures respond in a predictable way when used according to the assay instructions. Each lot of "reporter cells" must pass quality control testing before it is incorporated into the final test kit.
Ease of Use
- Prepare Samples
- Thaw kit reagents
- Set up assay following assay specific procedures
- Incubate
- Add substrate
- Read luminescence
Correlation to International Units
The cytokine supplied with the kits have been calibrated against the appropriate WHO International Reference Standard.