Calbiotech Neonatal TSH Elisa

SUMMARY AND EXPLANATION 
Determination of hypothyroidism within the first few days of birth has been recognized as the single most important diagnostic tests in neonates by the American Thyroid Association. The need for its early detection and treatment hast resulted in the establishment of screening centers by federal and state health departments. A program of early screening of neonates for congenital hypothyroidism was started in Quebec, Canada in the early seventies. They used dry blood spots on filter paper as the sampling device. Very soon the program was followed by other major public health institutions in Canada and the US. By 1978 almost one million infants had been screened and an incidence rate of congenital hypothyroidism was established to be approximately 1 in 7000 births. Congenital hypothyroidism is probably the single most common preventable cause of mental retardation. Diagnosis and treatment of congenital hypothyroidism within the first 1-2 months after birth appears to be necessary in order to prevent severe mental retardation.

PRINCIPLE OF THE TEST 
The Calbiotech Neonatal Thyroid Stimulating Hormone (TSH)) is a sandwich ELISA in blood spot dried on WHATMAN type 903 filter paper. In the assay, streptavidin coated wells are incubated with blood spots and biotin-conjugated monoclonal antibody anti TSH to form a streptavidin-biotin mAbTSH complex. After washing steps, other HRP-labeled mAb anti TSH is added to recognize the previous complex and complete the sandwich. Unbound HRP-labeled mAb is then removed by the washing steps. TMB Substrate is added, resulting in the development of blue color. The color development is stopped with the addition of stop solution, and the absorbance is spectrophotometrically measured at 450nm. A standard curve is prepared relating color intensity to the concentration of TSH.

STORAGE AND STABILITY 
1. Store the kit at 2-8ºC. 
2. Keep microwells sealed in a dry bag with desiccants. 
3. The reagents are stable until expiration of the kit. 
4. Do not expose test reagents to heat, sun or strong light.