NEONATAL TSH Screening
Quantitative fluorometric determination of thyroid-stimulating hormone
from neonatal dried blood spots.
The NEONATAL TSH Screening FLISA is a fluorescent enzyme immunoassay for the quantitative determination of thyroid-stimulating hormone in dried blood spots from newborns, for congenital hypothyroidism screening.
Designed for professional use in screening laboratories. For in vitro diagnostic use only - not intended for self or confirmatory testing.
Regulatory Status: CE-IVDR
Format: 192/576 tests
Analyte: thyroid-stimulating hormone (TSH
Method: fluorescent enzyme immunoassay (sandwich ELISA)
Sample: DBS (903®/226 paper) - 3.2 mm punch
Storage: 2-8°C
Automation: Manual or automated
Turn around time: 3h
General information
Advantages
Compatible instruments & Related kits
The NEONATAL TSH Screening FLISA is a sandwich ELISA in which two monoclonal anti-TSH antibodies recognize native TSH in the blood specimen. The oxidation of 3-(4-Hydroxyphenyl)propionic acid (HPPA) by Horseradish Peroxidase (HRP)-labelled detection antibody will lead to a fluorogenic product. The measured fluorescent signal is directly proportional to the concentration of TSH in the test sample.
Test principle
Congenital hypothyroidism is one of the most common preventable causes of intellectual disability, most often caused by an absent or underdeveloped thyroid gland.
Detected within the first days of life and treated with thyroid hormone replacement, affected children develop normally; left untreated, the deficiency causes irreversible neurodevelopmental damage - which is why it is a cornerstone of newborn screening worldwide.
Elevated screening results are not diagnostic on their own and require confirmatory testing.
Disease
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