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多中心参考值:共享参考限值。

Multicentric reference values: shared reference limits.

作者信息

Ferré-Masferrer M, Fuentes-Arderiu X, Alvarez-Funes V, Güell-Miró R, Castiñeiras-Lacambra M J

机构信息

Servei de Bioquímica Clínica, Ciutat Sanitària i Universitària de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.

出版信息

Eur J Clin Chem Clin Biochem. 1997 Sep;35(9):715-8.

PMID:9352235
Abstract

In order to obtain shared reference limits, three laboratories in the same geographical area with a homogeneous population have developed a proposal to produce multicentric reference values. The strategy simulates a virtual laboratory, actually formed by the laboratories involved; the reference limits produced in the virtual laboratory are in fact derived from the blend of reference values obtained by each laboratory. Each laboratory has chosen its own reference sample and has measured the biochemical quantities under study. Reference individuals (n = 171) and 15 biochemical quantities among the most measured in clinical laboratories were selected. The reference values obtained in each laboratory were blended when permitted by the Harris & Boyd test (Clin Chem 1990; 36:265-70). The multicentric reference limits obtained by the virtual laboratory for each quantity were estimated according to the recommendations of the International Federation of Clinical Chemistry. For each quantity, each laboratory, with the results observed in their reference sample, estimated the diagnostic specificity, using as cut-off values the corresponding multicentric reference limits. Each observed value of diagnostic specificity was compared with the theoretical diagnostic specificity value, equal to 0.975, that should be observed when a reference limit is used as cut-off value. The multicentric reference limits obtained by the virtual laboratory are valid in all cases with the exception of the upper reference limit for the concentrations of calcium(II) and urate in serum in one of the laboratories.

摘要

为了获得共享的参考限值,同一地理区域内的三个实验室针对同质人群制定了一项生成多中心参考值的提议。该策略模拟了一个虚拟实验室,实际上由参与的实验室组成;虚拟实验室产生的参考限值实际上源自每个实验室获得的参考值的混合。每个实验室都选择了自己的参考样本,并测量了所研究的生化指标。选择了参考个体(n = 171)以及临床实验室中测量最多的15种生化指标。当经Harris & Boyd检验(《临床化学》1990年;36:265 - 70)允许时,将每个实验室获得的参考值进行混合。虚拟实验室针对每种指标获得的多中心参考限值根据国际临床化学联合会的建议进行估算。对于每种指标,每个实验室利用其在参考样本中观察到的结果,将相应的多中心参考限值用作临界值来估算诊断特异性。将观察到的每个诊断特异性值与理论诊断特异性值(等于0.975,这是在将参考限值用作临界值时应观察到的)进行比较。虚拟实验室获得的多中心参考限值在所有情况下均有效,但其中一个实验室血清中钙(II)和尿酸盐浓度的上参考限值除外。

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