The evolution and limitations of accuracy and precision standards
The evolution and limitations of accuracy and precision standards
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DOI：
10.1016/s0009-8981(96)06493-5
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发表时间：
1997-04-25
影响因子：
5
通讯作者：
Doumas, BT
中科院分区：
文献类型：
--
作者：
Doumas, BT
根据正常范围(Tonks)、复合生物变异(Cotlove)、个体内生物变异(Aspen Conference，美国病理学家学会)、医学意义(Bar-nett，Skendzel)以及医学意义和生物变异的组合(Fritsche，Klee)，定义了最大允许分析不精密度的范围。由于基于医学意义的误差限制没有基于生物变异的误差限制严格，因此基于医学意义的性能目标更有可能由实验室实现，而不是由生物变异定义的。大多数临床科学家意识到，将分析CV限制在生物CV的一半或更少的目标是武断的，对于绝大多数对患者没有好处的实验室测试来说，因为总变异的主要组成部分不是分析不精确；而是个体内变异本身。此外，实验室检测的目的是帮助医生确认或排除潜在的诊断和监测治疗，而不是检测与正常值的微小偏差。测试值的微小变化往往是无法解释的，或者导致代价高昂但徒劳无功的调查。鉴于用于卫生保健的资源日益减少，我们必须确定每一项检测所需的准确性和精密度。虽然提高某些检测的准确性是可取的，因为大多数检测的进一步改进与患者护理无关，因为很少有检测本身具有病因学特征，而且诊断往往不是基于单一的实验室结果做出的。如果需要更高的精确度，也必须负担得起，而且收益应该大于成本。(C)1997年爱思唯尔科学公司。
Limits of maximum allowable analytical imprecision have been defined on the basis of normal range (Tonks), composite biological variation (Cotlove), intraindividual biological variation (Aspen Conference, College of American Pathologists), medical significance (Bar-nett, Skendzel), and a combination of medical significance and biological variation (Fritsche, Klee). Because error limits based on medical significance are less stringent than those based on biological variation, performance goals based on medical significance are more likely to be attained by laboratories than those defined by biological variation. Most clinical scientists realize that the goal to limit the analytical C.V. to one-half or less of the biological C.V. is arbitrary, and for the large majority of laboratory tests of no benefit to the patient, for the major component of total variation is not the analytical imprecision; but the intraindividual variation itself Furthermore, the purpose of laboratory testing is to help physicians confirm or exclude potential diagnoses and monitoring therapy rather than detecting small deviations from normal values. Small changes in test values are quite often uninterpretable or lead to costly albeit fruitless investigations. In view of diminishing resources for health care we must establish the accuracy and precision required for each test. While improving the accuracy of some tests would be desirable, for most of them further improvement would be irrelevant to patient care because few tests are pathognomonic by themselves and quite often diagnosis is not made on the basis of a single laboratory result. If more accuracy is desirable, it must also be affordable and benefits should outweigh costs. (C) 1997 Elsevier Science B.V.