Introduction to Congenital Hypothyroidism
Congenital Hypothyroidism is a condition in which a baby’s thyroid gland does not produce enough thyroid hormones at birth. Thyroid hormones play an important role in regulating a child’s metabolism, brain development, and physical growth.
Causes: underdeveloped or absent thyroid gland, misplaced thyroid gland, thyroid gland unable to produce Thyroxine (T4) and mutations in genes related to thyroid development: PAX8 and TSHR – related to hormone synthesis (DOUX2, SLC5A5, TG and TPO)
Incidence: the incidence of congenital hypothyroidism in newborns is from 1/3000 to 1/4000
Semi-automatic solution:
- Product name: DELFIA® Neonatal Thyroxine (T4)
- Product code: A065-110
- Manufacturer: Wallac Oy – Finland
- Packing: 960 tests
- Test principle:
The DELFIA® Neonatal T4 test is a solid-phase time-resolved fluorescence immunoassay based on the competitive reaction between europium-labeled T4 and a T4 sample for a limited amount of inhibits the binding site on a T4-specific monoclonal antibody (derived from a mouse). The use of 8-anilino-1-naphthalenesulfonic acid (ANS) and salicylate in the Neo T4 Assay Buffer facilitates the release of T4 from bound proteins. The assay thus measures the total amount of T4 in the sample. A second antibody, against mouse IgG, is coated onto the solid phase and binds to the thyroxine–IgG complex, facilitating separation between the bound antibody and free antigen. The Enhancement Solution separates the europium ions from the labeled T4 into solution where they form highly fluorescent chelates with the components of the enhancer. The fluorescence in each well is then measured. The fluorescence intensity of each sample is inversely proportional to the concentration of T4 present in the sample.
Application: The kit is used to screen for congenital hypothyroidism on dried blood spots of newborns from 2 to 4 days old on the VICTORTM 2D fluorescence measuring device. Suitable for hospitals with small and medium sample volumes.
Other equipment required for the test:
- VICTORTM 2D Fluorometer
- Wallac DBS Puncher or Panthera-Puncher™ 9 Dry Blood Puncher
- DELFIA® Plateshake
- DELFIA Trio Plate Washer
Automated Solution
- Product Name: GSP® Neonatal Thyroxine (T4) kit
- Product Code: 3302-0010
- Manufacturer: Wallac Oy – Finland
- Packing: 1152 tests
- Test Principle:
The GSP Neonatal T4 test is a solid-phase time-resolved fluorescence immunoassay based on the competitive reaction between europium-labeled T4 and a T4 sample for a limited number of binding sites on a T4-specific monoclonal antibody (derived from mice). The use of 8-anilino-1-naphthalenesulfonic acid (ANS) and salicylate in the Neo T4 Assay Buffer facilitates the release of T4 from bound proteins. The assay therefore measures the total amount of T4 in the sample. A second antibody, against mouse IgG, is coated onto the solid phase and binds to the thyroxine IgG complex, facilitating separation between the bound antibody and free antigen. The Enhancement Solution separates the europium ions from the labeled T4 into solution where they form highly fluorescent chelates with the enhancer components. The fluorescence in each well is then measured. The fluorescence intensity of each sample is inversely proportional to the concentration of T4 present in the sample.
- Application: The kit is used to screen for G6PD deficiency on dried blood spots of newborns aged 2-4 days on the GSP® system. Suitable for hospitals and testing centers with medium and large sample volumes.
Other equipment required for testing:
- GSP® System
- Wallac DBS Puncher or Panthera-Puncher™ 9
