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Congenital Hypotyroidism (CH) (TSH)

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The NEONATAL TSH Screening FLISA is a fluorescent enzyme immunoassay designed for the quantitative measurement of thyroid stimulating hormone (TSH). This device is intended for screening congenital hypothyroidism using neonatal samples, with blood spots dried on 903® or 226 filter paper.

This assay is dedicated to professional use in diagnostic laboratories. The device is not for self-testing.

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.

General information

Format: 192 – 576 determinations
Storage: At 2-8°C
Possible automation: Yes
Turn around time: Less than 3 hours

Establishment of a sustainable newborn TSH-screening program in the People's Democratic Republic of Laos: https://pubmed.ncbi.nlm.nih.gov/33440296/

Neonatal Screening for Congenital Hypothyroidism through Dried Blood Spots: A Cross-sectional Study: https://doi.org/10.7860/JCDR/2023/65497.18618

Test principle

Congenital hypothyroidism in newborns is defined as a deficiency of thyroid hormones present at birth. It is one of the most common preventable causes of intellectual disability worldwide.
What causes hypothyroidism in newborns is an abnormal development of the thyroid gland in about 85% of cases, or by a disorder of thyroid hormone biosynthesis in 10-15% of cases. These disorders cause primary hypothyroidism with high concentrations of thyroid stimulating hormone (TSH) and low levels of thyroxine (T4). Secondary hypothyroidism, or central hypothyroidism, is rarer and results from TSH deficiency. However, peripheral congenital hypothyroidism is due to an abnormality in the transport, metabolism, or action of thyroid hormones.
There are also forms of transient congenital hypothyroidism, most often affecting premature children. These transient forms usually resolve spontaneously within months or years.


Thyroid hormones play a key role in psychomotor development and growth, in the body’s thermoregulation process, in maintaining muscle tone, or in bowel movements.
Symptoms of congenital hypothyroidism in newborns are often absent, although some are mildly hypotonic and sleep more. Specific symptoms often appear only after several weeks. They include difficulty in sucking, constipation, prolonged jaundice, myxedematous facies and macroglossia,abdominal distension with umbilical hernia and hypotonia. Slowed growth and delayed psychomotor development are usually apparent.

Disease

Advantages

icon fast
Turn Around Time is less than 3 hours
icon flexibility
Different packagings to accommodate to laboratory needs
icon adaptability
Protocol available for manual and automated procedures
icon accurate
Quantitative test with controls and calibration curves supplied on blotting paper
icon complementary
T4 screening test available for confirmation of presumptive positive samples
icon comprehensive
All reagents and plates are included in the kit.

Linked products

LaCar
The NEONATAL TOTAL-T4 Screening ELISA is a colorimetric enzyme immunoassay for the quantitative determination of total thyroxine (TT4).
LaCar
The NEONATAL TSH Screening ELISA is a colorimetric enzyme immunoassay for the quantitative determination of thyroid stimulating hormone (TSH).
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