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APPLICATION OF CLSI EP15A3 GUIDELINE FOR VERIFICATION OF NEONATAL PHENYLALANINE MEASUREMENT METHOD IN DRY BLOOD SAMPLES ON PERKIN ELMER’S VICTOR 2D SYSTEM
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Abstract
Background: Analytical method verification is crucial for laboratories before proceeding to the testing of patients' samples. Objectives: The purpose of this study was to verify the performance of neonatal phenylalanine measurement in dry blood samples on Perkin Elmer’s VICTOR 2D system for newborn screening of Phenylketonuria. Subjects and methods: The verification of precision and trueness was conducted on the Perkin Elmer analyzer using the Perkin Elmer's Neonatal Phenylalanine kit and quality control materials in accordance with CLSI EP15-A3 guidelines. Results: The laboratory CVs of two QC levels were observed to be 18.2% and 8.58% respectively, lower than the manufacturer’s CVs of normal value 33.2% and Abnormal value 14.3%. The observed mean value of two QC levels were within the verification intervals. Conclusion: As a result, the precision and trueness of this Phenylalanine assay were verified, allowing it to be used for neonatal screening.
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Keywords
Phenylketonuria, Phenylalanine, newborn screening, method verification, EP15A3, Perkin Elmer.
References
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