Evaluation of the Performance of a Micromethod for Measuring Urinary Iodine by Using Six Sigma Quality Metrics
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
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±15.50μg/L, 108±32.40 μg/L, and 149±38.60 μg/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 μg/L, 135.14±13.53 μg/L, and 238.58±17.90μg/L, respectively. No laboratory showed a calculated total error (TEcalc)<total allowable error (TEa) for the low concentration level; all laboratories showed an acceptable performance for the medium-high level, and two laboratories showed an acceptable performance for the high level. When calculated against the Ensuring the Quality of UI Procedures (EQUIP) TEas, the performance of all laboratories was≤2.49 Sigma metrics at all concentrations. Only one laboratory had TEcalc<TEa for the medium-high and high concentrations. Conclusions: UIMM showed unacceptable performance for the iodine deficiency levels and variable performance at other concentrations according to different TEas.
Abstract
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±15.50μg/L, 108±32.40 μg/L, and 149±38.60 μg/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 μg/L, 135.14±13.53 μg/L, and 238.58±17.90μg/L, respectively. No laboratory showed a calculated total error (TEcalc)<total allowable error (TEa) for the low concentration level; all laboratories showed an acceptable performance for the medium-high level, and two laboratories showed an acceptable performance for the high level. When calculated against the Ensuring the Quality of UI Procedures (EQUIP) TEas, the performance of all laboratories was≤2.49 Sigma metrics at all concentrations. Only one laboratory had TEcalc<TEa for the medium-high and high concentrations. Conclusions: UIMM showed unacceptable performance for the iodine deficiency levels and variable performance at other concentrations according to different TEas.
참고문헌 (13)
- Hetzel BS, "Iodine deficiency disorders (IDD) and their eradication", Lancet, 2, pp.1126~1129 (1983)
- World Health Organization, "Assessment of iodine deficiency disorders and monitoring their elimination: a guide for programme managers. 3rd ed" (2007), WHO
- NHD, "Assessment of iodine deficiency disorders and monitor¬ing their elimination: a guide for programme managers. (WHO", pp.WHO, 01.1)
- Survey of iodine deficiency disorders in Peninsular Malaysia, "Institute for Medical Research, Ministry of Health, Malaysia", Ministry of Health, ~ (1996)
- Report on the monitoring of iodine deficiency in Pahang, Malaysia, "Selamat R", State Health Department of Pahang, ~ (2005)
- Report on the monitoring of urinary iodine in Perak, Malaysia, "State Health Department of Perak", State Health Department of Perak, ~ (2006)
- Selamat R, "Iodine deficiency status and iodised salt consumption in Malaysia: findings from a national iodine deficiency disorders survey", Asia Pac J Clin Nutr, 19, pp.578~585 (2010)
- Dunn JT, "Two simple methods for measuring iodine in urine", Thyroid, 3, pp.119~123 (1993)
- Pino S, "Ammonium persulfate: a safe alternative oxidizing reagent for measuring urinary iodine", Clin Chem, 42, pp.239~243 (1996)
- Husniza H, "A cost-effective modified micro method for measuring urinary iodine", Trop Biomed, 23, pp.109~115 (2006)
- Ohashi T, "Simple microplate method for determination of urinary iodine", Clin Chem, 46, pp.529~536 (2000)
- Westgard JO, "Six sigma quality design and control. 2nd ed" (2006), Westgard QC Inc.
- Westgard JO, "Basic method validation. 2nd ed" (2003), Westgard QC Inc.