Related Experiment Video
Updated: May 1, 2026
Biochemical Measurement of Neonatal Hypoxia
Published on: August 24, 2011
Performance Validation of the NeoBase 2 Non-Derivatized MSMS Assay Kit and Cutoff Values Establishment of Term and
Zhihui Wan1, Wei Liu1, Yanhong Zhai1
1Department of Laboratory Medicine, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing Maternal and Child Health Care Hospital, Beijing, China.
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.
