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Categorizing and Establishing CD4 Service Equivalency: Testing of Residual, Archived External Quality Assessment Scheme Sample Panels Enables Accelerated Virtual Peer Laboratory Review.
Cytometry Part B: Clinical Cytometry ( IF 2.3 ) Pub Date : 2019-02-28 , DOI: 10.1002/cyto.b.21772
Deborah Kim Glencross 1, 2 , Lindi Marie Coetzee 1, 2
Affiliation  

BACKGROUND Testing of collated, curated residual archived external quality assessment (EQA) trial material, with pre-established true (consensus) values collated into 25-sample panels enables virtual peer review of a laboratory's proficiency. In this study, we introduce how archived EQAS samples/panels can establish equivalency of CD4 reporting across multiple laboratories in a national program. METHODS Curated unused trial material from archived EQAS CD4 trials were collated into 25-sample panels comprising three sets of five-sample replicates and at least three duplicate samples. Panel-samples were tested using predicate methods of participating laboratories and proficiency determined by calculating a Standard Deviation Index (SDI) for each panel-sample reported according to retrospective consensus pooled trial outcomes. All data were plotted using MS Excel and Graphpad-Prism with SDI limits between -2 and +2 SDI to define acceptable performance. Percentage similarity analysis determined agreement. Bead-count-rate data was used to determine pipetting error. RESULTS Tight clustering of SDI outcomes predicted acceptable laboratory proficiency with acceptable accuracy and precision as evidenced by mean SDI < 0.5 and SD of SDI < 0.5. Random pipetting error was identified with aberrant BCR. Systematic under-reading of results was noted in one lab with excellent precision but mean SDI > 1.6. Additional training requirements were evident where a respective laboratory's SD of SDI exceeded 0.7. CONCLUSIONS Archival panel testing undertaken across a network of CD4 laboratories using the same CD4 method to simultaneously test the same panel prior to national implementation highlighted proficient laboratories and was useful for identifying sites with service deficiencies and immediate additional training needs. © 2019 International Clinical Cytometry Society.

中文翻译:

分类和建立CD4服务等效性:测试残留的,已归档的外部质量评估方案样本面板可加快虚拟对等实验室审查的速度。

背景技术整理整理后的残留存档外部质量评估(EQA)试验材料的测试,将预先建立的真实(共识)值整理到25个样本面板中,就可以对实验室的能力进行虚拟同行评审。在这项研究中,我们介绍了已归档的EQAS样本/面板如何在国家计划中的多个实验室中建立CD4报告的等效性。方法将来自存档的EQAS CD4试验的经过整理的未使用的试验材料整理成25个样本的面板,包括三组,每组五份重复样品,至少三份重复样品。使用参与实验室的谓词方法对样本进行测试,并通过根据回顾性共识汇总试验结果计算报告的每个样本的标准偏差指数(SDI),确定熟练程度。所有数据均使用MS Excel和Graphpad-Prism绘制,SDI限制在-2和+2 SDI之间,以定义可接受的性能。百分比相似性分析确定了一致性。磁珠计数率数据用于确定移液误差。结果SDI结果的紧密聚类预测了可接受的实验室熟练程度,具有可接受的准确度和精确度,这由平均SDI <0.5和SDI SD <0.5所证明。异常BCR识别出随机吸液错误。在一个实验室中,对结果的系统性读取不足被认为具有出色的精度,但平均SDI> 1.6。当相应实验室的SDI SD超过0.7时,显然还有其他培训要求。结论在国家实施之前,跨CD4实验室网络进行的档案小组测试使用相同的CD4方法同时测试同一小组,这突显了熟练的实验室,对于识别服务不足和即时额外培训需求的站点很有用。©2019国际临床细胞计量学会。
更新日期:2019-02-28
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