National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in clinical practice: quality requirements.
National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in clinical practice: quality requirements.
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美国国家临床生物化学研究院实验室医学实践指南在临床实践中使用肿瘤标志物：质量要求。
DOI：
10.1373/clinchem.2007.094144
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发表时间：
2008-08
影响因子：
9.3
通讯作者：
National Academy of Clinical Biochemistry
中科院分区：
文献类型：
--
作者：
Sturgeon CM;Hoffman BR;Chan DW;Ch'ng SL;Hammond E;Hayes DF;Liotta LA;Petricoin EF;Schmitt M;Semmes OJ;Söletormos G;van der Merwe E;Diamandis EP;National Academy of Clinical Biochemistry
这份报告介绍了最新的国家临床生物化学实验室医学实践指南，总结了使用肿瘤标记物的质量要求。一个小组委员会制定了当前临床实践中与血清和组织肿瘤标记物相关的分析质量指南。另外两个小组委员会提出了与发展中的微阵列和质谱学技术特别相关的建议。在常规实践中最佳使用肿瘤标记物的先决条件包括：制定正确的临床问题以确保选择适当的测试，遵守良好的临床和实验室实践(例如，将不正确的患者和/或标本识别、管型或时间的风险降至最低)，使用国际标准化和特征明确的方法，仔细遵守制造商的说明，以及对来自内部质控和能力测试样本的信息做出积极和及时的反应。非常理想的程序包括那些旨在最大限度地减少由于异嗜性抗体或钩子效应等干扰而报告错误结果的风险，以促进提供信息性临床报告(例如，累积和/或图形报告、适当推导的参考间隔和解释性评论)，以及在可能的情况下通过电子健康记录将这些报告与其他患者信息整合的那些程序。在引进微阵列和质谱仪等新技术之前，还必须进行广泛的验证，包括分析的所有阶段。研究人员、诊断公司、临床和实验室用户以及监管机构之间的对话有助于提供高质量的肿瘤标记物服务。实施这些建议，适应当地的实践，应该会鼓励优化肿瘤标记物的临床使用。
This report presents updated National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines summarizing quality requirements for the use of tumor markers. One subcommittee developed guidelines for analytical quality relevant to serum and tissue-based tumor markers in current clinical practice. Two other subcommittees formulated recommendations particularly relevant to the developing technologies of microarrays and mass spectrometry. Prerequisites for optimal use of tumor markers in routine practice include formulation of the correct clinical questions to ensure selection of the appropriate test, adherence to good clinical and laboratory practices (e.g., minimization of the risk of incorrect patient and/or specimen identification, tube type, or timing), use of internationally standardized and well-characterized methods, careful adherence to manufacturer instructions, and proactive and timely reactions to information derived from both internal QC and proficiency-testing specimens. Highly desirable procedures include those designed to minimize the risk of the reporting of erroneous results attributable to interferences such as heterophilic antibodies or hook effects, to facilitate the provision of informative clinical reports (e.g., cumulative and/or graphical reports, appropriately derived reference intervals, and interpretative comments), and when possible to integrate these reports with other patient information through electronic health records. Also mandatory is extensive validation encompassing all stages of analysis before introduction of new technologies such as microarrays and mass spectrometry. Provision of high-quality tumor marker services is facilitated by dialogue involving researchers, diagnostic companies, clinical and laboratory users, and regulatory agencies. Implementation of these recommendations, adapted to local practice, should encourage optimization of the clinical use of tumor markers.
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影响因子：
9.3
作者：
Bristow, A;Berger, P;Sturgeon, C
通讯作者：
Sturgeon, C
影响因子：
9.3
作者：
Bossuyt, PM;Reitsma, JB;de Vet, HCW
通讯作者：
de Vet, HCW
DOI：
10.1016/0731-7085(89)80079-2
发表时间：
1989-01-01
影响因子：
3.4
作者：
EKINS, RP
通讯作者：
EKINS, RP
影响因子：
4.4
作者：
Kallioniemi, OP
通讯作者：
Kallioniemi, OP
DOI：
10.1017/s0266462303000102
发表时间：
2003-12-01
影响因子：
3.2
作者：
Durieux, P;Ravaud, P;Chaussade, S
通讯作者：
Chaussade, S