Evaluation of the Performance of a Micromethod for Measuring Urinary Iodine by Using Six Sigma Quality Metrics

BACKGROUND: The urinary iodine micromethod (UIMM) is a modification of the conventional method and its performance needs evaluation. METHODS: UIMM performance was evaluated using the method validation and 2008 Iodine Deficiency Disorders survey data obtained from four urinary iodine (UI) laboratories. Method acceptability tests and Sigma quality metrics were determined using total allowable errors (TEas) set by two external quality assurance (EQA) providers. RESULTS: UIMM obeyed various method acceptability test criteria with some discrepancies at low concentrations. Method validation data calculated against the UI Quality Program (TUIQP) TEas showed that the Sigma metrics were at 2.75, 1.80, and 3.80 for 51+/-15.50 microg/L, 108+/-32.40 microg/L, and 149+/-38.60 microg/L UI, respectively. External quality control (EQC) data showed that the performance of the laboratories was within Sigma metrics of 0.85-1.12, 1.57-4.36, and 1.46-4.98 at 46.91+/-7.05 microg/L, 135.14+/-13.53 microg/L, and 238.58+/-17.90 microg/L, respectively. No laboratory showed a calculated total error (TEcalc)

A cost-effective modified micromethod for measuring urine iodine

A modified micromethod for measuring urine iodine was successfully established and validated. The micromethod showed good correlation with the method used by several World Health Organization (WHO) collaborative laboratories (y = 0.9342x + 4.6213; r = 0.962; p = 0.01; n = 50). The micromethod also showed good agreement when compared to the reference WHO method. The sensitivity of the assay was 13.809 ug/L (n = 8) and mean recoveries were 114, 103 and 106% at concentrations of 30, 40 and 50 ug/L (n = 3) respectively. At iodine concentrations of 51 +/- 15.5, 108 +/- 32.4 and 149 +/- 38.6 ug/L, intra-assay coefficient of variations (CVs) were 13%, 7% and 5% respectively (n = 20), and inter-assay CVs were 10%, 15% and 7% respectively (n = 10). The assay showed good linearity plot (y = 1.0407x + 60.451; r = 0.993; n = 3).