An evaluation of IRT neonatal analytical performance in AutoDELFIA®

Jornal Brasileiro de Patologia e Medicina Laboratorial

Raquel Weber²  Michele Pavan²  André Canto De Souza¹  Simone Martins De Castro¹ 

[1] ,Universidade Federal do Rio Grande do Sul Pharmacy School

关键词: neonatal screening;    cystic fibrosis;    validation studies;    trypsinogen;    triagem neonatal;    fibrose cística;    estudos de validação;    tripsinogênio;   

DOI  :  10.1590/S1676-24442013000600002

来源: SciELO

【 摘 要 】

Neonatal screening programs for cystic fibrosis (CF) usually consist of an immunoreactive trypsinogen assay. The objective of this study was to validate the AutoDELFIA® Neonatal immunoreactive trypsinogen kit. We carried out a comparative study between two equipments. The following results were yielded: random error = 26.6%systematic error = 4.95% and analytical error = 31.5%. Several factors contributed to the assay variations in dried blood spot, namely chromatographic, hematocrit and total blood volume effects. These factors should be taken into account in the assessment of validation results. The studied kit can be deployed in neonatal screening routine.

【 授权许可】

CC BY   
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