Department of Laboratory Medicine, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing Maternal and Child Health Care Hospital, Beijing, China.
Fetal Pediatr Pathol. 2024 Sep-Oct;43(5):366-375. doi: 10.1080/15513815.2024.2386659. Epub 2024 Aug 6.
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.
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.
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.
The performance of the NeoBase 2 kit is acceptable and can be implemented in clinical diagnostic laboratories.
采用 NeoBase 2 非衍生 MSMS 检测试剂盒（NeoBase 2 试剂盒）进行新生儿筛查，在将其应用于临床诊断实验室之前，应对其性能进行验证。
使用 NeoBase 2 试剂盒中的剩余干血斑样本、质控材料以及从 NSQAP 收到的能力验证材料。对 Waters ACQUITY TQD MS/MS 系统与 NeoBase 2 试剂盒用于新生儿筛查的性能进行精密度、准确度、检测限、定量下限、回收率和稳定性验证。确定了截止值，并研究了早产儿中需要不同截止值的分析物。
批内和批间精密度范围为 3.95%至 14.41%。准确度和稳定性在 15%以内。所有分析物的检测限、定量下限和回收率均令人满意。建立了足月和早产儿的截止值。
NeoBase 2 试剂盒的性能可接受，可应用于临床诊断实验室。
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