System, method, and test strip for
solid phase, electrochemical, quantitative analysis of analytes contained in
biological fluid samples. Preliminary to analysis, a
test sample solution can be applied to a
sample collection pad associated with the
solid phase test environment of the test strip. The
test sample solution and a test kit
reagent are thereby initially contacted, under
assay conditions, within this
solid phase test environment, and caused to migrate along a fluid pathway therein. Irrespective of the
assay format (competitive
assay, sandwich assay, etc.), a test kit
reagent (e.g. labeled substance) and the
analyte of interest (e.g. proteins, hormones or enzymes, small molecules, polysaccharides, antibodies, nucleic acids, drugs, toxins, viruses or
virus particles, portions of a
cell wall and other compounds which have specific or characteristic markers that permit their identification), either interact with one another to form a complex, or, alternatively, compete with one another for interaction with another test kit
reagent, resulting in the concentration of an indicator substance within a delimited area of the solid phase. Thereafter, the delimited area of the test strip is subjected to electrochemical analysis and the results determined by monitoring an electrochemical transition in the form of an indicator, or derivative of the indicator (e.g. indicator species), by potentiostatic or potentiometric quantitative analysis (e.g.
anodic stripping voltammetry). This electrochemical transition of the indicator has a characteristic electrical
fingerprint that can be measured and which, when compared to a standard, can be correlated with the concentration of the
analyte in the sample. This method is suitable for the determination / monitoring of therapeutic range of drugs (anti-convulsants drugs), determination of critical and potentially dangerous levels of endogenous materials which are indicative of
disease states (
prostate cancer), and numerous other applications presently requiring elaborate and time-consuming clinical laboratory analysis.