Performance Validation of the NeoBase 2 Non-Derivatized MSMS Assay Kit and Cutoff Values Establishment of Term and Preterm Neonates.

IF 0.7 4区医学 Q4 PATHOLOGY

Fetal and Pediatric Pathology Pub Date : 2024-09-01 Epub Date: 2024-08-06 DOI:10.1080/15513815.2024.2386659

Zhihui Wan, Wei Liu, Yanhong Zhai, Zhijun Ma, Zheng Cao

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引用次数: 0

Abstract

Objective: NeoBase 2 Non-derivatized MSMS assay kit (NeoBase 2 kit) was used for newborn screening, the performance of the NeoBase 2 kit should be validated before its implementation in clinical diagnostic laboratories.

Methods: Leftover dried blood spot samples, quality control materials in the NeoBase 2 kit, and proficiency testing materials received from the NSQAP were used. Precision, accuracy, LOD, LLOQ, recovery, and stability were carried out to verify the performance of the Waters ACQUITY TQD MS/MS system with the NeoBase 2 kit for newborn screening. Cutoffs were determined and analytes requiring different cutoffs in preterm neonates were investigated.

Results: Within-run and between-run precisions ranged from 3.95% to 14.41%. The accuracy and stability were within 15%. All analytes demonstrated acceptable LOD, LLOQ, and recoveries. Cutoffs for term and preterm neonates were established.

Conclusions: The performance of the NeoBase 2 kit is acceptable and can be implemented in clinical diagnostic laboratories.

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NeoBase 2 非衍生化 MSMS 检测试剂盒的性能验证及足月儿和早产儿临界值的确定

目的：将 NeoBase 2 非衍生化 MSMS 检测试剂盒（NeoBase 2 试剂盒）用于新生儿筛查，在临床诊断实验室使用前应验证 NeoBase 2 试剂盒的性能：方法：使用剩余的干血斑样本、NeoBase 2 试剂盒中的质控材料和国家质检中心提供的能力验证材料。对精密度、准确度、LOD、LLOQ、回收率和稳定性进行了测试，以验证沃特世 ACQUITY TQD MS/MS 系统与 NeoBase 2 试剂盒在新生儿筛查中的性能。确定了临界值，并对早产新生儿中需要不同临界值的分析物进行了研究：运行内和运行间的精确度在 3.95% 至 14.41% 之间。准确度和稳定性均在 15%以内。所有分析物的LOD、LLOQ和回收率均可接受。确定了足月和早产新生儿的临界值：NeoBase 2 试剂盒的性能是可以接受的，可以在临床诊断实验室中使用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Fetal and Pediatric Pathology 医学-病理学

CiteScore

3.00

自引率

0.00%

发文量

审稿时长

6-12 weeks

期刊介绍： Fetal and Pediatric Pathology is an established bimonthly international journal that publishes data on diseases of the developing embryo, newborns, children, and adolescents. The journal publishes original and review articles and reportable case reports. The expanded scope of the journal encompasses molecular basis of genetic disorders; molecular basis of diseases that lead to implantation failures; molecular basis of abnormal placentation; placentology and molecular basis of habitual abortion; intrauterine development and molecular basis of embryonic death; pathogenisis and etiologic factors involved in sudden infant death syndrome; the underlying molecular basis, and pathogenesis of diseases that lead to morbidity and mortality in newborns; prenatal, perinatal, and pediatric diseases and molecular basis of diseases of childhood including solid tumors and tumors of the hematopoietic system; and experimental and molecular pathology.