Assessment of response/error relationship and imprecision profile in immunoassay using computer simulation procedures.

Simulation procedures were applied to assess the response/error relationship (RER) and the imprecision profile (IP) for two model assays, a T4 RIA and a TSH IFMA both using duplicate samples. In order to define the reference functions, the mean data obtained in 10 successive experiments for dose/response curve (DR), RER and IP were employed. The following conclusions emerged from the study: (a) run sizes of ca. 100 duplicates can acceptably describe within-assay IPs, irrespective of the data distribution through the dose range; (b) the contribution of DR fitting error to the total variability of estimate can be disregarded in the case of small series but not for the larger ones; (c) the variability components related to the response error can be efficiently controlled by applying criteria based on RER parameters.