Robertson E A, Csako G, Faust A, Elin R J
Clin Chem. 1984 Aug;30(8):1402-5.
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.
通过五个质量控制指标跟踪SMAC连续流动分析仪校准材料的两次更换（间隔五个月）的效果：三种正常和异常对照血清、患者结果中心第50百分位数的平均值以及正常个体的平均值。在校准材料的第一次和第二次更换后，20项不同测试中分别有8项和6项测试显示出指数所表明的具有统计学意义的变化。20项测试中有两项的累积变化被认为具有医学意义。仅在校准材料更换前对患者血清的拆分样本进行的前瞻性研究仅预测了后来上述指数所证明的测试结果中一半的显著变化。
