An evaluation of IRT neonatal analytical performance in AutoDELFIA®

Abstract

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.

Evaluation of the Genetic Screening Processor for the Performance of Newborn Screening Tests

“…Those effects should also be considered in the determination of the more adequate cutoff value, to avoid an increase in false-negative or false-positive results. 8…”

“…Those effects should also be considered in the determination of the more adequate cutoff value, to avoid an increase in false-negative or false-positive results. 8 Besides the specific differences in each assay, some advantages of GSP are developing a quicker and less labor-intensive assay, possibility to add plates while the instrument is running, high capacity with up to 26 plates and up to 13 techniques, traceability of consumables, operators and operations, easy-to-use software, and automatic elimination of the waste. Disadvantages are high need of deionized water (12.5 mL/s); quite heavy instrument (610 kg), may need special reinforcement of the floor; refrigeration noisy; and some mechanical and software problems during the evaluation: need for a trained technical assistance service.…”

Silica nanoparticle-based microfluidic immunosensor with laser-induced fluorescence detection for the quantification of immunoreactive trypsin

“…c o m / l o c a t e / y a b i o [21,29,23,30,31]. Depending on the country, the IRT cutoff value currently used for CF newborn screening ranges between 65 and 70 ng ml -1 [32][33][34].…”