Performance Validation of the NeoBase 2 Non-Derivatized MSMS Assay Kit and Cutoff Values Establishment of Term and Preterm Neonates.
Fetal Pediatr Pathol
; 43(5): 366-375, 2024.
Article
in En
| MEDLINE
| ID: mdl-39105619
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Infant, Premature
/
Neonatal Screening
Limits:
Humans
/
Newborn
Language:
En
Journal:
Fetal Pediatr Pathol
Journal subject:
PATOLOGIA
/
PEDIATRIA
Year:
2024
Document type:
Article
Affiliation country:
China
Country of publication:
United kingdom