Abstract
There is no worldwide recognized reference system and standard for urinary albumin measurement until now, so the analytical quality from different laboratories has always varied. In this study, we aimed to evaluate the analytical performance of a urinary albumin assay system using Sigma-metric, and thereby choose a suitable control rule to guarantee the analytical quality of the assays.Two levels of diluted reference material (ERM-DA47OK/IFCC) were used to calculate the biases, the coefficient of variation (CV) were calculated from six months of internal quality control measurements at two levels, and the external quality assessment standard of China for urinary albumin (30%) was used as the total allowable error(TEa).The Sigma values for quality control levels 1 and 2 were 4.28 and 6.14, leading to recommended Westgard rules of 13s/22s/R4s/41s (N = 2, R = 2) and 13s(N = 2, R = 1), respectively. Westgard rule 13s/22s/R4s/41s(N = 2, R = 2) was selected for the quality control of the urinary albumin measurements, and with it, the power function graph showed a high efficacy for determining the detection errors with a probability of false rejection of 1.004% and a probability of error detection of 98.80%.With a TEa of 30% recommended by the external quality assessment standard of China, Westgard rule 13s/22s/R4s/41s(N = 2, R = 2) with a high efficacy for determining the detection error is recommended for the quality control of urinary albumin measurements.
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