The fitting, acceptance, and processing of standard curve data in automated immunoassay systems, as exemplified by...

Methodologies for establishing standard curves on automated immunoassay systems are dependent on the computational capability of the instrument, its throughput, and, perhaps, the technical experience of the user. Here, factors constraining this approach are discussed in general and the procedures used for the Serono SR1 analyzer are considered in detail. The SR1 is a moderate-throughput, fully automated immunoassay system capable of performing tests for (currently) 18 analytes. The associated user-generated standard curves are utilized not only for interpolation of results but also for evaluation of system performance. The choices of curve-fitting method, weighting of data, acceptance criteria, and outlier rejection are taken out of the hands of the user and are made a vital and integral part of the system. I justify this approach and demonstrate how a sensible mathematical approach must be tailored to the configuration of the instrument.