CTK TSH ELISA

The CTK TSH ELISA is a solid-phase enzyme-linked immunosorbent assay. The four components are:

  • Solid microwells pre-coated with streptavidin
  • TSH Calibrators
  • TSH Assay Control
  • Liquid TSH Enzyme Conjugate Mixture comprised of two individual antibody conjugates: an anti-human TSH antibody labelled with horseradish peroxidase (HRP-Ab) and an anti-human TSH antibody labelled with biotin (Bio-Ab)

This test is intended for the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum. It is intended to be used by professionals as an aid in the diagnosis of thyroid dysfunction. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers.

Recommended for use:

  • Aid in diagnosis of thyroid dysfunction
  • Monitor treatment of hypothyroidism and hyperthyroidism
  • Screening pregnant women during the first trimester

The synthesis and secretion of TSH from the anterior pituitary is stimulated by the hypothalamic tripeptide thyrotropin releasing hormone (TRH), which is released from the hypothalamus in response to low levels of circulating T4/T3. T4 and T3 are responsible for regulating diverse biochemical processes throughout the body which are essential for normal development as well as metabolic and neural activity.

The mean TSH level in the general population is approximately 1.50 µIU/mL. Most physicians consider TSH levels > 5-10 μIU/mL as evidence of mild or subclinical hypothyroidism which occurs in about 4.6% of the adult population in the U.S., and TSH levels < 0.2-0.4 μIU/mL as evidence of hyperthyroidism, which is present in 1.3% of population in the U.S. However, it is important for each facility to establish its own TSH reference interval based on representative sampling of the local population.

Combining the measurement of TSH with the thyroid hormones (T3/T4) can provide more information for the determination of thyroid status.

  • Sensitivity: Detects TSH concentrations as low as 0.03 µIU/mL at 2SD
  • Specificity: No cross-reactivity detected with AFP at 10,000 ng/mL, ASA at 10 mg/mL, bilirubin at 10 μg/mL, CEA at 10,000 ng/mL, diiodotyrosine at 10 μg/mL, FSH at 7,000 mIU/ML, hCG at 6,600 uIU/mL, hemoglobin 10 μg/mL, LH at 6,600 mIU/mL, lipids at 10 μg/mL, T3 at 10 μg/mL, and T4 at 10 μg/mL, respectively
  • Accuracy: r= 0.98 against reference ELISA by an external lab
  • Intra Assay Precision: CV ≤ 4.3%
  • Inter Assay Precision: CV ≤ 10.2%
  • Hook Effect: No hook effect up to 1,000 μIU/mL
  • Shelf life: 18 months
  • Open kit stability:  8 weeks at 2-8°C, or until the expiration date
  • Streptavidin Coated Microwells
  • TSH Calibrators:
    • C1 (0 ng/mL)
    • C2 (0.4 ng/mL)
    • C3 (2.0 ng/mL)
    • C4 (5.0 ng/mL)
    • C5 (10.0 ng/mL)
    • C6 (20.0 ng/mL)
    • C7 (40.0 ng/mL)
  • TSH Assay Control
  • TSH Enzyme Conjugate Mixture
  • Wash Buffer (40X Concentrate)
  • TMB Substrate
  • Stop Solution
  • Product Insert
  • ELISA Working Sheet

Catalog #

Product

Quantity

Specimen

E1035

TSH ELISA

96/kit

S/P

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