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TSH ELISA Kit (Thyroid Stimulating Hormone)

INTENDED USE

Human TSH ELISA kit is a reliable quantitative procedure for measuring thyroid stimulating hormone (TSH, thyrotropin) in human serum samples. This assay has a sensitivity detection limit of 0.06 mIU/l.

BACKGROUND

Thyroid stimulating hormone (TSH) is also called thyrotropin, it has a molecular weight of 28,000 Daltons and is secreted by the pituitary gland. The function is to regulate the synthesis and release of T3 and T4 by the thyroid gland. It is composed of alpha and beta subunits, the alpha subunits are similar alpha subunits found in LH, FSH and hCG glycoprotein hormones alpha subunits whereas the beta is more specific and is different from one hormone to another.

The following assay is a second-generation assay that is able to provide a tool that can offer a means for discriminating the hyperthyroid-euthyroid range. Additionally, determining the levels of TSH is equally helpful in differentiating secondary and tertiary hypothyroidism (hypothalamic) from the primary thyroid disease. One of the most important maker in the diagnosis of thyroid disorders is the measurement of serum levels, where elevated concentrations thyrotropin is a good indicator for overt primary hypothyroidism and a decrease in the thyroid reserve levels.

CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

  • Microtiterwells, 12 x 8 (break apart) strips: Wells coated with TSH antibody.
  • Standard 0-5: Concentrations: 0,0.25, 0.75, 2.0, 5.0, 15 mIU/L. Made up from human TSH, the standards are calibrated against WHO International Standard for thyroid stimulating hormone IRP (81/565).
  • Control Low and Control High: Containing TSH.
  • Enzyme Conjugate: Consisting of anti-TSH antibody conjugated to horseradish peroxidase (HRP).
  • Substrate Solution: Tetramethylbenzidine (TMB).
  • Stop Solution: 0.5 M H2SO4, Avoid contact with the stop solution. It may cause skin irritations and burns.
  • Wash Solution (40x Concentrated).

SENSITIVITY

The minimum sensitivity detection limit for thyroid stimulating hormone (thyrotropin) using current TSH ELISA kit was approximately 0.06 mIU/l. The dynamic range for this assay is between 0.25 – 15 mIU/l.

ASSAY CHARACTERISTICS

– Assay Dynamic Range: 0.06 – 15.0 mlU/l
– Specificity (Cross Reactivity): No cross-reaction was found for hCG (100,000 mlU/l), hFSH (100 mlU/l), HLH (100 mlU/l).
– Sensitivity: Analytical sensitivity of 0.06 mlU/l
– Intra-Assay Variation: 3.16 – 3.88%
– Inter-Assay Variation: 3.32 – 9.17%
– Interfering Substances: None
– High-Dose-Hook Effect: No hook effected observed up to 2000 mlU/l of TSH.

REFERENCES

  1. Determination of Protein Bound Iodine. Joumal Biological Chemistry (1948) 173, 175. Barker, S.B.
  2. A Radioimmunoassay of Thyrotropin. J. Clinical Endocrinol. (1971) 33, 865 (1971). Chopra, I.J., Solomon, D.H., and Ho, R.S.
  3. Effects of Drugs on Clinical Laboratory Tests. Clinical Chemistry (1975) 21, 3660. Young, D.S., Pestaner, L.C., and Gilberman, U.

ADDITIONAL INFORMATION

  • Full Name: TSH ELISA Kit (Thyroid Stimulating Hormone)
  • Reactivity: Human
  • Sample Type: Serum
  • Sensitivity: 0.06 mIU/l

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