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首页> 外文期刊>Journal of Inborn Errors of Metabolism & Screening >Evaluation of the Genetic Screening Processor for the Performance of Newborn Screening Tests
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Evaluation of the Genetic Screening Processor for the Performance of Newborn Screening Tests

机译：遗传筛查处理器对新生儿筛查测试性能的评估

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The collection of dried blood spots (DBSs) on filter paper has been a powerful tool in newborn screening (NBS) programs and in other fields. However, filter paper has been associated with some level of imprecision due to the filter paper matrix effect. In order to minimize measurement variations, these interferences should be evaluated by NBS assays. The aim of this study is to evaluate the performance of genetic screening processor (GSP) equipment in comparison with a widely used AutoDELFIA and to discuss the limitations and advantages of this new technology in NBS. We evaluated the performance of 3 NBS assays in DBS using GSP in comparison with AutoDELFIA. To determine the inaccuracy and the intra-assay precision, a comparative study and a replication experiment were performed. In the comparative study, human thyroid-stimulating hormone (hTSH) assay showed the highest correlation coefficient, followed by 17???±-OH-progesterone and immunoreactive trypsinogen (IRT) assays. The results of the present study suggest that the GSP equipment and kits are suitable for implementation and have acceptable performance for NBS routine. Genetic screening processor assay tends to underestimate hTSH and IRT concentrations in the clinically relevant range when compared to AutoDELFIA assays. More studies are necessary to reevaluate cutoff values. Furthermore, the equipment has advantages when compared with AutoDELFIA, such as methodology with more specificity, reduction in the processing time, and randomized routine. This helps promoting faster dynamic technical processes and faster report generation.
机译：在滤纸上收集干血斑（DBS）已成为新生儿筛查（NBS）计划和其他领域的强大工具。然而，由于滤纸基质效应，滤纸与某种程度的不精确度相关。为了最小化测量差异，应通过NBS分析评估这些干扰。这项研究的目的是与广泛使用的AutoDELFIA相比，评估基因筛选处理器（GSP）设备的性能，并讨论该新技术在NBS中的局限性和优势。我们与AutoDELFIA相比，使用GSP评估了DBS中3种NBS测定的性能。为了确定准确性和批内分析的准确性，进行了比较研究和复制实验。在比较研究中，人甲状腺刺激激素（hTSH）测定法显示出最高的相关系数，其次是17--OH孕酮和免疫反应性胰蛋白酶原（IRT）测定法。本研究的结果表明，GSP设备和套件适合实施，并且对于NBS常规具有可接受的性能。与AutoDELFIA分析相比，基因筛选处理器分析往往会低估临床相关范围内的hTSH和IRT浓度。重新评估临界值需要更多的研究。此外，与AutoDELFIA相比，该设备还具有优势，例如方法更专一，处理时间减少以及常规程序随机化。这有助于促进更快的动态技术流程和更快的报告生成。

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