External quality assessment for immunohistochemistry: experiences from NordiQC

External quality assessment for immunohistochemistry: experiences from NordiQC
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免疫组织化学的外部质量评估:NordiQC 的经验

DOI:
10.3109/10520295.2015.1033462
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发表时间:
2015
影响因子:
1.6
通讯作者:
S. Nielsen
S. Nielsen
中科院分区:
工程技术4区
文献类型:
--
作者:
S. Nielsen

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摘要免疫组织化学(IHC)在外科和临床病理学中被常规应用,因为它对许多肿瘤病变的诊断和分类是必不可少的。尽管它广泛使用了40多年,但缺乏标准化是一个主要问题;分析前、分析和分析后阶段的许多因素影响最终结果。北欧免疫组织化学质量控制(NordiQC)成立于2003年,旨在评估IHC的实验室间一致性,主要集中在分析部分。在2003年至2013年期间,对26,000多张国际碳氢化合物幻灯片进行了评估;15个−实验室参加了每一次评估。总体而言,评估的染色结果中有71%被评估为足以用于诊断,而29%被认为不足。所有用于提交给NordiQC的染色玻片的IHC方案都经过了评估,重点是实验室进行的技术校准,并确定了给出足够或不充分结果的具体参数。结果不充分的最常见原因是:一抗校准不当,一抗使用不当,表位检索方法选择不当,热诱导表位检索(HIER)不足,检测试剂盒使用不当。大约90%的不充分结果的特征是信号太弱或假阴性染色,而在其余10%的结果中,信噪比较差或假阳性染色。确定阳性和阴性组织对照以确保IHC检测的适当校准,结合针对方案优化的个性化建议,改善了许多标记物的IHC染色,从而改善了IHC结果的实验室间一致性。NordiQC 11年来产生的总体数据清楚地表明,外部质量评估是对内部质量控制的宝贵和必要的补充。
Abstract Immunohistochemistry (IHC) is applied routinely in surgical and clinical pathology, because it is essential for diagnosis and sub-classification of many neoplastic lesions. Despite its extensive use for more than 40 years, lack of standardization is a major problem; many factors during the pre-analytical, analytical and post-analytical phases affect the final results. Nordic immunohistochemical Quality Control (NordiQC) was established in 2003 to evaluate the inter-laboratory consistency of IHC, focusing mainly on the analytical part. More than 26,000 IHC slides have been evaluated during the period 2003–2013; 15 − 300 laboratories have participated in each assessment. Overall, 71% of the staining results assessed have been evaluated as sufficient for diagnostic use, while 29% were judged insufficient. All IHC protocols used for the stained slides submitted to NordiQC have been evaluated by focusing on the technical calibration performed by the laboratories, and specific parameters that gave sufficient or insufficient results have been identified. The most common causes for insufficient results were: inadequate calibration of the primary antibody, use of an inadequate primary antibody, inappropriate choice of epitope retrieval method, insufficient heat induced epitope retrieval (HIER) and use of an inadequate detection kit. Approximately 90% of the insufficient results were characterized by either a signal that was too weak or false negative staining, whereas in the remaining 10%, a poor signal-to-noise ratio or false positive staining was seen. Identification of positive and negative tissue controls to ensure appropriate calibration of the IHC assay combined with individually tailored suggestions for protocol optimization have improved IHC staining for many markers and thus inter-laboratory consistency of the IHC results. The overall data generated by NordiQC during 11 years clearly indicates that external quality assessment is a valuable and necessary supplement to internal quality control.
DOI: 10.1043/1543-2165-134.6.907
发表时间: 2010-06
影响因子: 4.6
作者:
M. E. Hammond;Daniel F. Hayes;M. Dowsett;D. C. Allred;K. Hagerty;S. Badve;P. Fitzgibbons;G. Francis
通讯作者: M. E. Hammond;Daniel F. Hayes;M. Dowsett;D. C. Allred;K. Hagerty;S. Badve;P. Fitzgibbons;G. Francis