کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1966484 1538723 2009 6 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Specifications for trueness and precision of a reference measurement system for serum/plasma 25-hydroxyvitamin D analysis
موضوعات مرتبط
علوم زیستی و بیوفناوری بیوشیمی، ژنتیک و زیست شناسی مولکولی زیست شیمی
پیش نمایش صفحه اول مقاله
Specifications for trueness and precision of a reference measurement system for serum/plasma 25-hydroxyvitamin D analysis
چکیده انگلیسی

BackgroundThe divergence in analytical quality of serum/plasma 25-hydroxy-vitamin D analysis calls for defining specifications for a reference measurement system.MethodsFundamentally, in a reference measurement system, there should be a relationship between the analytical specifications for higher- (reference) and lower-order (routine) measurements. Therefore, when setting specifications, we started with limits for routine imprecision (CVrou) and bias (Brou) using 4 models: (1) the misclassifications in diagnosis, (2) biological variation data (reference interval (RI) and monitoring), (3) expert recommendations, and (4) state-of-the-art performance. Then, we used the derived goals to tailor those for reference measurements and certified reference materials (CRMs) for calibration by setting the limits for CVref at 0.5 CVrou, Bref at 0.33 Brou, max. uncertainty (Umax) at 0.33 Bref.ResultsThe established specifications ranged between CVrou ≤ 22%, Brou ≤ 10%, CVref ≤ 11%, Bref ≤ 3.3%, Umax 1.1% (model 3) and CVrou ≤ 4%, Brou ≤ 2.6%, CVref ≤ 2%, Bref ≤ 0.9%, Umax 0.3% (model 2, monitoring).ConclusionsModel 2 (monitoring) gave the most stringent goals, model 3, the most liberal ones. Accounting for state-of-the-art performance and certification capabilities, we used model 2 (RI) to recommend achievable goals: for routine testing, CVrou ≤ 10%, Brou ≤ 5%, for reference measurements, CVref ≤ 5%, Bref ≤ 1.7%, and for CRMs, Umax 0.6%.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Clinica Chimica Acta - Volume 408, Issues 1–2, 1 October 2009, Pages 8–13
نویسندگان
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