Levey-Jennings Analysis Uncovers Unsuspected Causes of Immunohistochemistry Stain Variability.
Levey-Jennings Analysis Uncovers Unsuspected Causes of Immunohistochemistry Stain Variability.
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DOI：
10.1097/pai.0000000000000260
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发表时间：
2016
期刊：
影响因子：
--
通讯作者：
Bogen SA
中科院分区：
文献类型：
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作者：
Vani K;Sompuram SR;Naber SP;Goldsmith JD;Fulton R;Bogen SA
几乎所有的临床实验室检查都使用客观的定量质量控制（QC）措施，结合Levey-Jennings分析和Westgard规则。相比之下，临床免疫组织化学（IHC）检测依赖于主观的定性QC审查。在临床IHC检测中使用Levey-Jennings分析进行QC评估的结果尚不清楚。为了研究这个问题，我们进行了1-2个月的初步试验，其中在3个临床IHC实验室中对HER-2或孕酮受体（PR）的QC进行定量，并使用Levey-Jennings图进行分析。此外，常规组织对照补充了由偶联到8微米玻璃珠上的HER-2或PR肽抗原组成的新QC。在机构1，这种更严格的分析确定了HER-2组织对照的降低，这在主观评价中没有注意到。减少是由于组织对照本身的异质性。在机构2，我们发现PR组织对照的一天突然下降，由于复染变异性，主观评价也未检测到。在机构3，发现QC偏移，但仅在每个载玻片上安装两个质控品中的一个。QC偏移是由于使用了仪器的选择性试剂滴区分配功能。这些事件均未影响患者诊断。这些病例示例说明，组织质控品的主观QC评价可检测到总体检测失败，但无法检测到细微变化。事实上，每个研究中心都出现了QC问题，并且仅在初步研究中，这表明免疫组织化学染色变异性可能是一个未被充分认识的问题。
Almost all clinical laboratory tests use objective, quantitative measures of quality control (QC), incorporating Levey-Jennings analysis and Westgard rules. Clinical immunohistochemistry (IHC) testing, in contrast, relies on subjective, qualitative QC review. The consequences of using Levey-Jennings analysis for QC assessment in clinical IHC testing are not known. To investigate this question, we conducted a 1-2 month pilot test wherein the QC for either HER-2 or progesterone receptor (PR) in 3 clinical IHC laboratories was quantified and analyzed with Levey-Jennings graphs. Moreover, conventional tissue controls were supplemented with a new QC comprised of HER-2 or PR peptide antigens coupled onto 8-micron glass beads. At institution 1, this more stringent analysis identified a decrease in the HER-2 tissue control that had escaped notice by subjective evaluation. The decrement was due to heterogeneity in the tissue control itself. At institution 2, we identified a one-day sudden drop in the PR tissue control, also undetected by subjective evaluation, due to counterstain variability. At institution 3, a QC shift was identified, but only with one of two controls mounted on each slide. The QC shift was due to use of the instrument’s selective reagent drop zones dispense feature. None of these events affected patient diagnoses. These case examples illustrate that subjective QC evaluation of tissue controls can detect gross assay failure but not subtle changes. The fact that QC issues arose from each site, and in only a pilot study, suggests that immunohistochemical stain variability may be an under-appreciated problem.