Gentel Biosciences

Assay Development Process

Gentel's core competency is the custom development and production of highly validated multiplexed immunoassays. Gentel will manage the entire development process from the procurement of reagents through the final data delivery of your processed samples, according to your desired specifications. Additionally, Gentel will process your samples and deliver analyzed data or enable you to implement the developed assays in your lab. Well characterized reagents are sourced from reliable vendors or your proprietary reagents can be utilized. Rigorous standardized assay development processes will be used to validate the assay for:

• Lowest level of detection (LLOD): derived by assaying high replicate numbers of blank sample matrices along with standard curves. LLOD defined as the the back calculated concentration based on the mean blank signal level + 2x Standard Deviation.

• Lowest level of quantitation (LLOQ): derived by assaying replicate numbers of decreasingly concentrated analyte spiked into matrix. LLOQ is defined as the lowest concentration level of spiked analyte in matrix where replicate coefficient of variation is less than or equal to 20%

• Dynamic range: defined as the quantitatively detectable concentration range from the LLOQ to the back calculated concentration at saturation.

• Precision and accuracy: validated by evaluating replicate analyte spiked matrices of know concentrations. Minimal acceptance criteria is mean measurements within 80%–120% recovery of known concentrations and less than or equal to 20% coefficient of variation.

• Specificity: validated by single plex evaluation of each analyte and its cognate detector to observe capture antibody/antigen interactions as well as a blank to observe capture antibody/detector antibody interactions. Specificity threshold is less than or 5% non-specific signal when compared to the corresponding appropriate positive signal up to saturation.

• Interference factors: evaluated to ensure they have no deleterious effects on assay performance.

Benefits of Gentel's multiplexed assays

• Reduce financial risk of protracted in house development
• Accelerated access to market or study data
• Validated high quality data
• IP security of possessing your own proprietary panels
• Picogram sensitivities
• Precision and consistency to clinical standards
• Low sample volume enabled by multiplexing
• Automated
• Collaboration so your assay and data is useful and easy to understand

Applications

• Quantitative Assays utilize sandwich antibody arrays and standard controls for highly accurate and reproducible low to medium density multiplexed protein concentration measurements
• Profiling Assays yield relative abundance measurements of medium to high density multiplexed analytes using sandwich antibody arrays
• Screening Assays characterize large numbers of proteins using direct sample labeling and extremely high density antibody arrays
• Protein Arrays probe for dose response, auto-immunity or pathogen response by using high density antigen or lysate arrays