Fetal Pediatr Pathol. 2024 Aug 6:1-10. doi: 10.1080/15513815.2024.2386659. Online ahead of print.
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.
PMID:39105619 | DOI:10.1080/15513815.2024.2386659
