Category NameThyroid MarkersMethodELISAPrincipleELISAControls Standards0,1.5,3,6,12.5,25,50µIU/mlSensitivity0.05µIU/mlSample50 µlRuntime75 minWavelength450 nmSafetyPlease refer to MSDSShelflife18 Months
5. Linearity
Two different patient samples were diluted with the “0” calibrator to 1:2, 1:4 and 1:8. TSH values were assayed
and results were corrected with the dilution factor. The results of these dilution tests are as follows:
Serum Original Value ( mIU/ml) Percentage of Recovery
1:2 1:4 1:8
12
30.0
08.6
93.3
109.0
98.6
89.4
84.8
85.0
REFERENCES
1. Frank JE; Faix JE; Hermos RJ; Mullaney DM; Rojan DA; Mitchell ML; Klein RZ Thyroid function in very low birth
weight infants: effects on neonatal hypothyroidism screening. J Pediatr 1996;128(4):548-54.
2. Thakur C; Saikia TC; Yadav RN. Total serum levels of triiodothyronine (T3) thyroxine (T4) and thyrotropine (TSH)
in school going children of Dibrugarh district: an endemic goitre region of Assam. Indian J Physiol Pharmacol
1997;41(2):167-70.
3. Morimoto K; Inouye K.A sensitive enzyme immunoassay of human thyroid-stimulating hormone (TSH) using
bispecific F(ab')2 fragments recognizing polymerized alkaline phosphatase and TSH. J Immunol Methods
1997;205(1):81-90
4. Maes M; Mommen K; Hendrickx D; Peeters D; D'Hondt P; Ranjan R; De Meyer F; Scharp´e S. Components of
biological variation, including seasonality, in blood concentrations of TSH, TT3, FT4, PRL, cortisol and
testosterone in healthy volunteers. Clin Endocrinol (Oxf) 1997;46(5):587-98
Thyroid Stimulating Hormone (TSH)
ELISA
Catalog No.: TS045T (96 tests), TS045T4 (48 tests)
INTENDED USE
The CBI TSH ELISA kit is used for the quantitative measurement of TSH in human serum or plasma.
SUMMARY AND EXPLANATION
Thyroid Stimulating Hormone (TSH) is a glycoprotein hormone secreted by the pituitary gland and regulates the
synthesis/ release of T3 and T4 by thyroid gland. TSH has two subunits, namely alpha and beta. The alpha subunit is
similar to the alpha subunit found in LH, FSH and hCG glycoprotein hormones. However, the beta subunit is specific
and differs from hormone to hormone. The serum TSH measurement is one of the most important tools in the diagnosis
of thyroid disorders. Increased serum TSH is an early and sensitive indicator of decreased thyroid reserve and overt
primary hypothyroidism. Decreased of TSH levels is an indicator of TSH-independent hyperthyroidism (Graves disease).
The sensitivity of this ELISA test is 0.05 mIU/ml.
PRINCIPLE OF THE TEST
The CBI TSH is a solid phase sandwich ELISA method. The samples, and anti-TSH-HRP conjugate are added to the
wells coated with Mab to TSH beta subunit. TSH in the patient’s serum binds to anti-TSH MAb on the well and the anti-
TSH second antibody then binds to TSH. Unbound protein and HRP conjugate are washed off by wash buffer. Upon
the addition of the substrate, the intensity of color is proportional to the concentration of TSH in the samples. A standard
curve is prepared relating color intensity to the concentration of the TSH.
MATERIALS PROVIDED 48 tests 96 tests
1. Microwell coated with TSH MAb 6x8x1 12x8x1
2. TSH Standard: 7 vials ( ready to use) 0.35 0.7ml
3. TSH Enzyme Conjugate: 1 bottle (ready to use) 6 ml 12 ml
4. TMB Substrate: 1 bottle (ready to use) 12ml 12ml
5. Stop Solution: 1 bottle (ready to use) 12ml 12ml
6. 20X Wash concentrate: 1 bottle 25ml 25ml
MATERIALS NOT PROVIDED
1. Distilled or deionized water
2. Precision pipettes
3. Disposable pipette tips
4. ELISA reader capable of reading absorbance at 450nm
5. Absorbance paper or paper towel
6. Graph paper
STORAGE AND STABILITY
1. Store the kit at 2 - 8 °C.
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. |