Effect of calibration material lot changes on results for the "SMAC".

The effect of two changes of calibration material (separated by five months) for the SMAC continuous-flow analyzer was followed by means of five quality-control indices: three normal and abnormal control sera, the mean of the central 50th percentile of patients' results, and the mean value for normal individuals. After the first and second changes of calibration materials, eight and six, respectively, of the 20 different tests exhibited statistically significant changes as shown by the indices. The cumulative shift for two of the 20 tests was considered medically significant. Prospective studies on split samples of patients' sera before the change in calibration material only predicted half the significant changes in test results later evidenced by the above-mentioned indices.