A computerized approach to statistical quality control for radioimmunoassays in the clinical chemistry laboratory.

Methods for statistical quality control for the clinical laboratory in general, and radioimmunoassay in particular, have been proposed for many years. Unfortunately, only a very small number of laboratories have adapted these procedures. By use of teletypes and other remote terminals, it is possible for all laboratories to access centralized computers where a general purpose quality control program can be stored. This relieves each laboratory of the costly task of developing software, provides some degree of inter-laboratory standardization and facilitates comparison of precision and accuracy between laboratories. A prototype program for this purpose is described. This program evaluates within-assay and between-assay variability, by means of an analysis of variance for a one-way classification random-effects model, and can monitor any assay parameter by use of control chart techniques. In addition, several tests are provided to evaluate the temporal stability of the assay system, and appropriate tests for outliers are included. Also, methods are described for combination of information from several quality control samples. This provides a valid basis for adjustment of assay results or for outright rejection of an assay. For convenience, this program is designed for output on a teletype or similar terminal located in the laboratory. Simplified versions of this program can be readily adapted to desk-top calculators. The original purpose for developing this system was to provide the clinical laboratory with a simple, general, and flexible method for assessing the performance of radioimmunoassays, but its usefulness should extend to virtually all assay methods.

The progression and evaluation of hetatologic and serum biochemical values in the chimpanzee.

Summary statistics of various hematologic and serum biochemical measures are presented for a colony of 74 chimpanzees (Pan troglodytes). Covariance analysis of longitudinal values revealed a progression of some measures with maturity. Equations for evaluating these measures as they relate to the health of individual colony members and new additions to the colony were formulated. From these equations, confidence bounds (95%), which can be regarded as normative ranges, were established for each of the measures. The literature on hematologic and serum biochemical values in the chimpanzee, especially as they pertain to the evaluation and progression of values, is reviewed.