The Biomarker Research Clinical Chemistry Laboratory features
newly refurbished labs equipped with state of the art instrumentation
including fluorescence/luminescence/absorbance microplate reader and
automated liquid handling system.
Method development and validation is conducted along the lines of
current CLSI, FDA, EMEA, ISO and ICH guidance. Increasing levels of
assay validation are implemented throughout the biomarker pipeline,
including evaluation of:
- Curve fitting
- Range
- Limits of Detection and Quantitation
- Accuracy
- Precision
- Sensitivity
- Specificity
- Linearity
- Interference
- Biological and technical pre-analytical factors
- Uncertainty of measurement
Biomarker evaluation is conducted through a phased, protocol driven
approach, in line with relevant good practice guidance (e.g.CONSORT,
REMARK, STARD) using validated assays with internal quality control
procedures. Sample numbers are determined through prospective power
analysis by a statistician.