Effect of Dried Blood Spot Quality on Newborn Screening Analyte Concentrations and Recommendations for Minimum Acceptance Criteria for Sample Analysis

Effect of Dried Blood Spot Quality on Newborn Screening Analyte Concentrations and Recommendations for Minimum Acceptance Criteria for Sample Analysis
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DOI:
10.1373/clinchem.2015.247668
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发表时间:
2016-03-01
期刊:
影响因子:
9.3
通讯作者:
Moat, Stuart J.
Moat, Stuart J.
中科院分区:
医学1区
文献类型:
--
作者:
George, Roanna S.;Moat, Stuart J.

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背景:自20世纪70年代初以来,干血斑点分析已被常规用于新生儿筛查,近年来筛查的疾病数量大幅增加。方法:在血池中添加苯丙氨酸、酪氨酸、亮氨酸、蛋氨酸、辛酰卡尼汀、癸酰卡尼汀、异戊基卡尼汀、戊二酰卡尼汀、促甲状腺激素和免疫反应性胰酶原,使其达到英国筛查方案中使用的分析截止点的浓度。我们评估了卡片上的样品体积(10、20、50、75和100亩L)、打孔位置(中心和外围)和样品质量(双层、滤纸两侧涂血、多点、不足样品和使用后压缩样品)的影响。结果:血点压缩的结果显著降低(14%-44%),所有被测物质的结果(P<0.001)。对于所有被测浓度下的所有分析物,较小的血点产生的结果显著较低(10亩L样本大小为15%-24%,而50亩L样本大小为15%-24%)(P<0.001)。从外围冲床获得的结果高于从中央冲床获得的结果,尽管这并没有达到对所有分析物的统计学意义。不足的和多个斑点的样本显示结果不均。结论:所有的血点都含有
BACKGROUND: The analysis of dried blood spots has been used routinely for newborn screening since the early 1970s, and the number of disorders screened has expanded substantially in recent years. However, there is a lack of evidence regarding minimum blood spot quality acceptance criteria for sample analysis.METHODS: Blood pools were spiked with phenylalanine, tyrosine, leucine, methionine, octanoylcarnitine, decanoylcarnitine, isovalerylcarnitine, glutarylcarnitine, thyroid-stimulating hormone, and immunoreactive trypsinogen to concentrations at the analytical cutoffs used in UK screening protocols. We evaluated the effect of sample volume applied to the card (10, 20, 50, 75, and 100 mu L), punch location (central vs peripheral), and sample quality (double layering, applying blood to both sides of the filter paper, multispotting, applying insufficient sample, and compressing the sample after application).RESULTS: Compression of blood spots produced significantly lower results (14%-44%) for all analytes measured (P < 0.001). Smaller blood spots produced significantly lower results (15%-24% for 10-mu L vs 50-mu L sample size) for all analytes at all concentrations measured (P < 0.001). Results obtained from peripheral punches were higher than those from a central punch, although this did not reach statistical significance for all analytes. Insufficient and multispotted samples demonstrated heterogeneous results.CONCLUSIONS: All blood spots containing