The IBA scientific staff is experienced in all aspects of reagent purification, method development, assay optimization, performance validation, and clinical utility assessment.
- Identification of an appropriate analytical platform
- Evaluation of commercially available reagents
- Development of proprietary reagents
- Suitability of reagents on an analytical platform
Assay Development
- Determination of optimum method format
- Determination of key reagent concentrations
- Optimization of incubation times and temperatures
- Optimization of buffer formulations
Assay Formats
- Singleplexed immunoassays
- Radioimmunoassay (RIA)
- Multiplexed immunoassays
- Analytical HPLC chromatography
- Analytical FPLC chromatography
- Gel densitometry
Performance Qualification
- Evaluation of the method’s analytical performance: precision, linearity, parallelism, accuracy, dynamic range, interferences
- Determination of the assay’s minimum detectable concentration (MDC)
- Determination of the assay’s lower limit and upper limit of quantitation (LLQ, ULQ)
- Evaluation of the method’s clinical performance: range of normal values, specificity, correlation with a reference method
The analytical and clinical method performance evaluations are performed in accordance with the approved validation procedures of the Federal Drug Administration (FDA), The International Committee on Harmonization (ICH), and The National Committee on Clinical Laboratory Standards (NCCLS).
Request Information
Let IBA customize and develop your bioassays and more!
Click here to request information.
To contact an IBA representative call (203) 315-5972
or e-mail: info@iba-analytics.com
|
|
