文摘
The least detectable concentration (LDC) and dynamicrange (DR) of three immunoassay systems are comparedusing four distinct antibodies (all specific for estradiol butwith different affinities) on each system. The systemsevaluated include the industry standard, ELISA, and twobiosensors, surface plasmon resonance and kinetic exclusion. In all cases, the measurements of inhibition curves(response vs estradiol concentration) were contracted tooutside experts (the biosensor manufacturers themselvesin the case of the biosensors), each of whom was suppliedwith the same blind samples. Each biosensor manufacturer also reported an estimate of the equilibrium dissociation constant (Kd) for each of the antibodies. TheLDC and DR observed for the kinetic exclusion biosensorare consistent with an interpretation of Kd limited detection while that from the other biosensor and ELISA showlimits of detection somewhat above those expected for Kdlimited performance. The determined LDC and DR of eachbiosensor is self-consistent in the sense that none of theinhibition data contradicts theoretical limits associatedwith the Kd as measured on that system; however, somecontradictions are apparent across platforms. The use ofmultiple antibodies of differing Kd improves confidencethat the observed differences in performance are associated with the immunoassay system rather than the particular analyte.