GLP3

Biomarker Testing Service

ELISA Biomarker Assays

UBRL provides biomarker testing and analysis services to support preclinical diagnostic research of new therapeutics. We perform biomarker assay development, validation, and profiling of disease panels using ELISA technique.

Universal Biomarker Testing & Validation Service (UBRL-BTS)

UBRL provides ELISA biomarker assay development and validation for biomarker identification using the following formats:

  • Competitive immunoassays for peptides and small molecules.
  • Immunometric “sandwich” ELISA format assays for large protein analytes including cytokines, cell stress proteins, and signaling pathway regulators.

Biomarker Assay Development:

Each assay undergoes rigorous testing to ensure high precision and accuracy while also delivering the sensitivity and specificity required to detect biological levels of analytes in a number of biological matrices including serum, plasma, CSF, urine, breast milk (human), human saliva, cell culture supernatant and cell lysates.

  • Inventory and selection of critical raw materials,
  • Determination and/or optimization of coating and revelation conditions,
  • Development and optimization of measuring conditions,
  • Method validation on samples for:
    • Inter and intra-batch accuracy of the measure.
    • Edge affect and assay drift.
    • Limit of quantification.
    • Specificity.
    • Linearity of the response.
    • Parallelism.
    • Correlation with a reference method.
    • Robustness.
    • Stability study.

The validation process results in a comprehensive data packet that is reviewed by quality assurance personnel, who ensure that the test results meet established procedures.

These procedures require that:

  • Controls meet established specifications.
  • Non-specific binding, low standard, and high standard signals meet the established specifications.
  • Sensitivity, determined by assaying multiple replicates of the zero standard, falls within the established specifications.
  • Standards match master calibrators within the established specifications.

Data generation & Result Reporting

UBRL Biomarker Testing Service (UBRL-BTS) conducts all work confidentially and responsively to our clients' needs. We strive to meet and exceed your expectations. UBRL tries to achieve the best communication with our clients, the results are communicated in a timely manner and in an agreed upon format. Option to customize the report is also available.