Evaluation of a Quantitative Solid Phase Reagent System for Determination of Blood Analytes

Abstract

In the first part of the Seralyzer system evaluation the precision and accuracy was studied with a total of 1245 clinical specimens, various commercial control sera, and pooled human sera. The calculated overall precision (between-run, and within-run) and day-to-day precision (% CV) was found to be within 3·0 to 5·4 for glucose, 2·8 to 7·1 for BUN, 1·5 to 6·2 for uric acid, 5·3 to 7·5 for bilirubin, and 3·2 to 8·6 for LDH. The clinical values are in agreement with values from respective comparative methods, as indicated by the regression statistics. The analysis of Seralyzer accuracy data using quality control sera showed in some cases a between-method difference. Supporting studies simulating additional important clinical situations showed that the clinical values for BUN, glucose, and uric acid of approximately 200 specimens from the emergency ward correlated with the respective comparative method values. In this phase of the study we verified that the instrument calibration was stable for a 24-hour period and that there is no effect of module (test) change on precision of Seralyzer determinations. The intra- and inter-laboratory performance in general practitioners' laboratories could be demonstrated using quality control sera.