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Working Towards Accreditation by the International Standards Organization 15189 Standard: How to Validate an In-house Developed Method an Example of Lead Determination in Whole Blood by Electrothermal Atomic Absorption Spectrometry

Garcia Hejl C, Ramirez JM, Vest P, Chianea D, Renard C

Laboratories working towards accreditation by the International Standards Organization (ISO) 15189 standard are required to demonstrate the validity of their analytical methods. The different guidelines set by various accreditation organizations...
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Evaluation of the Performance of a Micromethod for Measuring Urinary Iodine by Using Six Sigma Quality Metrics

Hussain H, Khalid NM, Selamat R, Wan Nazaimoon WM

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...
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Assessment of the Trueness and Inter-Laboratory Precision of Routine Uric Acid Assays Using 4 Frozen Pooled Serum Samples Measured by the Japan Society of Clinical Chemistry's HPLC Method

Jiang Y, Liu O, Xu G

BACKGROUND: Reference procedures are required for evaluating the accuracy of routine analytical systems for uric acid (UA). External quality assessment (EQA) for UA has only been conducted with quality controls...
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Can a Point-of-Care Troponin I Assay be as Good as a Central Laboratory Assay? A MIDAS Investigation

Peacock WF, Diercks D, Birkhahn R, Singer AJ, Hollander , Nowak R, Safdar B, Miller CD, Peberdy M, Counselman F, Chandra A, Kosowsky J, Neuenschwander J, Schrock J, Lee-Lewandrowski E, Arnold W, Nagurney J

BACKGROUND: We aimed to compare the diagnostic accuracy of the Alere Triage Cardio3 Tropinin I (TnI) assay (Alere, Inc., USA) and the PathFast cTnI-II (Mitsubishi Chemical Medience Corporation, Japan) against...
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