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THYROID GLAND: HORMONES AND DISEASE MARKERS

K201            K201A          K211            K212            K213

K214            K232            K131            K132



K201 Thyroid Stimulating Hormone (TSH) EIA, normal range

Thyroid stimulating hormone (TSH) is a glycoprotein with molecular weight ca.30kDa which is
secreted by hypophysis. A molecule of TSH consists of two noncovalently bound subunits: alpha- and
beta-. Beta-subunit determines biological activity and immunological specificity of TSH.
TSH stimulates thyroid gland to secrete thyroid hormones. TSH secretion in hypophysis is controlled
by a negative feedback regulation by thyroid hormones. TSH secretion is subject to circadian rhythms
with highest levels seen early in the morning (6 a.m.). Changes of TSH blood level during a day are
not significant; nevertheless, if the results do not correspond with clinical status and other laboratory
data, it is recommended to take and test another blood sample.
Determination of TSH level in serum is recommended in the following states and conditions:
1. Diagnostics of dysfunction of the thyroid gland
2. Hypothyroidism (TSH level is increased. The diagnosis is confirmed by low concentrations of total and
free T4 and T3. In mild subclinical forms when T4 and T3 levels are within normal ranges, determination
of TSH concentration is critical).
3. Hyperthyroidism (synthesis and secretion of TSH are inhibited); monitoring of replacement
therapy.
4. Screening for inherited hypothyroidism (on day 5 after birth TSH level in blood is determined). TSH level is
elevated just after birth but it comes within the normal range in several days (both in boys and in girls).
Serum TSH level is elevated during pregnancy, after physical stress, in individuals with lowered blood
pressure and lowered temperature. Secretion of TSH is inhibited by Cortisol and Growth hormone. Low
TSH levels are often seen in elderly people, in patients with chronic renal insufficiency, liver cirrhosis,
in retardation of sexual development, in secondary amenorrhea, Cushing syndrome, acromegaly.
In a present test system, beta chain specific monoclonal antibody XTB1 is used as capture reagent;
enzyme-labelled (Fab2)-fragment of another beta chain specific monoclonal antibody XTB2 is used
as tracer. This combination enables to minimize both cross-reactive reactions with other pituitary
hormones and false positivity caused by anti-species antibodies.

 

Sample type: serum, plasma                 Incubation: 30’/30’/15’, 370С                      Control sample: 1
Sample volume: 50 μl                           Calibrators: 6 (0-15 mIU/l)                         Shelf life: 12 months
Sensitivity: 0.1 mIU/l

 

K201A Thyroid Stimulating Hormone EIA, expanded range (TSH-plus EIA)

The kit is analogous to the previous one but has a higher sensitivity (0.025 mIU/l) and expanded range
(up to 50 mIU/l).
Attention: a microplate reader with two filters (450 nm and 492 nm) is necessary to measure
high TSH concentrations (>10 mIU/l) in this kit.


Sample type: serum, plasma                 Incubation: 60’/60’/15’, 370С                      Control sample: 1
Sample volume: 100 μl                         Calibrators: 7 (0-50 mIU/l)                         Shelf life: 12 months
Sensitivity: 0.025 mIU/l
 

K232 Thyroglobulin (TG) EIA                                                                                     New kit!

Thyroglobulin (TG) is a high MW (ca. 650-700 kDa) glycoprotein synthesized by the thyroid epithelial
cells. In normal thyroid gland, TG is secreted to the follicular lumen and undergoes iodination of tyrosine
residues leading to formation of thyroid hormones (T3 and T4). Minor quantities of TG penetrate to the
circulation in normal donors. Synthesis of TG is regulated by hormones (TSH, TRH, exogenous thyroid
therapy).
In differentiated thyroid carcinoma, serial determination of serum TG is used for post-treatment
monitoring. An elevation of serum TG in such patients indicates a presence of residual thyroid tissue,
relapse or metastatic growth of the tumor. The elevated serum TG are also observed in benign thyroid
diseases, e.g. thyroiditis, hyperthyroidism and non-toxic goiter. The monitoring of serum TG is also
used for prognostic evaluation of thyrostatic treatment of Graves’ disease.


Sample type: serum, plasma                 Incubation: 60’/15’, RT, shaker                   Control sample: 1
Sample volume: 50 μl                           Calibrators: 5 (0-400 ng/ml)                       Shelf life: 12 months
Sensitivity: 3 ng/ml
 

K211 Total Т3 EIA

Thyroid hormones thyroxin (T4) and 3,5,3’-triiodothyronine (T3) exert regulatory influences on growth,
differentiation, cellular metabolism and development of skeletal and organ systems. T4 and T3 in blood
are found both in free and bound form – mostly, they are bound to thyroxin binding globulin (TBG).
Only free forms of T3 and T4 exert hormonal activity also their percentage is very low – 0.3% for T3
and 0.03% for T4.
The concentration of T3 is much less than that of T4 but its metabolic activity is about 3 times greater.
About 80% of T3 is produced in peripheral tissues by deiodination of T4, and only 20% is secreted by
thyroid gland. That is why in hypothyroid patients T3 level may for a long time remain on the lower limit
of the normal range, because its loss may be compensated by enhanced conversion of T4 into T3.
Determination of T3 level is most useful in T3-hyperthyroidism because 5-10% of such patients
do not show significant changes in T4 level while concentration of T3 is highly elevated.
Elevated T3 levels are seen in early thyroid hypofunction, after intake of estrogens, oral contraceptives,
heroin, methadone, during pregnancy.
Decreased concentrations of T3 are found in initial stage of hyperthyroidism, acute and subacute
thyroiditis, after intake of androgens, dexamethasone, salycilates.

 

Sample type: serum, plasma                 Incubation: 30’/15’, 370С                           Control sample: 1
Sample volume: 50 μl                           Calibrators: 5 (0-15 nmol/l)                        Shelf life: 12 months
Sensitivity: 0.4 nmol/l
 

K212 Total T4 EIA

The concentration of T4 is generally accepted as an index of thyroid function which provide enough
information to differentiate between hyper-, hypo- and euthyroidism.
Elevation of total T4 is found in hyperthyroidism, in patients with tumors of pituitary gland, in subjects
with elevated TBG level (pregnancy, acute or chronic active hepatitis, estrogen-secreting tumors
or estrogen intake, hereditary elevation of TBG), in patients taking oral contraceptives, heroin,
methadone, thyroid preparations, TSH, thyroliberin.
Low total T4 is found in hypothyroidism, in patients with panhypopituitarism, in subjects with low TBG
level (acromegaly, nephritic syndrome, hypoproteinemia, chronic liver diseases, androgen-secreting
tumors, hereditary reduction), in patients taking aminosalicylic and acetylsalicylic acids, cholestyramine,
reserpine, potassium iodide, triiodothyronine.
 

Sample type: serum, plasma                 Incubation: 60’/15’, 370С                           Control sample: 1
Sample volume: 50 μl                           Calibrators: 5 (0-320 nmol/l)                      Shelf life: 12 months
Sensitivity: 13 nmol/l
 

K213 Free T3 EIA
K214 Free T4 EIA

Only free forms of T3 and T4 exert hormonal activity also their percentage is very low – 0.3% for T3
and 0.03% for T4. Although concentration of FT3 is lower than that of FT4, its metabolic activity is
about 3 times higher. Roughly 80% of serum T3 is produced by de-iodination of T4 in peripheral tissues
and only small amount – by direct synthesis in the thyroid gland. That is why T3 level in hypothyroid
states may for a long time stay at the lower level of its normal range, as its loss is compensated by
enhanced transformation of T4 into T3.
T4 serum concentration is generally accepted as an index of thyroid gland function capable of
differentiating between hyper-, hypo- and euthyroid states.
Elevation or decrease of free T3 and T4 are seen in the same states as for total T3 and T4 (see above
the information for K212 and K212) except for those states accompanied by changes in level of thyroidbinding
globulin (TBG; in such cases results for total T3 and T4 may not correspond to levels of their
free forms). At first, elevation of TBG level leads to a short-term decrease of free T3 and T4 levels.
Later on, secretion of T3 and T4 is enhancing until normalization of free T3 and T4 serum levels. And
vice-versa: if TBG level is low, total T3 and T4 levels are decreasing until normal concentrations of free
T3 and T4 are restored. Therefore, determination of free forms of T3 and T4 is more reliable as just
they exert hormonal activity.
Elevated TBG concentrations are seen in pregnancy, acute or chronic active hepatitis, acute or
intermittent porphyria, estrogen-secreting tumors or estrogen intake, taking of heroin, methadone,
perfenasine. Besides, TBG elevation may be hereditary.
Decreased TBG levels are seen in acromegaly, nephrotic syndrome, hypoproteinemia, chronic liver
diseases (cirrhosis, etc.), androgen-secreting tumors or androgen intake, taking of high doses of
glucocorticoids. TBG decrease may also be hereditary.

K213 Free T3 EIA

Sample type: serum, plasma                 Incubation: 60’/15’, 370С                           Control sample: 1
Sample volume: 50 μl                           Calibrators: 6 (0-40 pmol/l)                        Shelf life: 12 months
Sensitivity: 1 pmol/l
 

K 214 Free T4 EIA
 

Sample type: serum, plasma                 Incubation: 60’/15’, 370С                           Control sample: 1
Sample volume: 25 μl                           Calibrators: 5 (0-100 pmol/l)                      Shelf life: 12 months
Sensitivity: 2.5 pmol/l
 

K131 Thyroperoxidase autoantobodies (anti-TPO) EIA

Anti-TPO antibodies (formerly - thyroid microsomal antibodies) are directed against a target protein -
thyroid peroxidase (TPO) - located in the smooth endoplasmic reticulum of thyroid cells. The presence
of anti-TPO antibodies in serum is associated with thyroid autoimmune diseases (Graves’ disease and
Hashimoto’s thyroiditis). Anti-TPO antibodies mostly belong to the IgG class.
Low to moderate levels of serum anti-TPO antibodies can be found in some other autoimmune pathology
(eg systemic lupus erythematosus or Sjogren syndrom) and, rarely, in apparently healthy subjects
(especially elderly women). Anti-TPO antibodies are more sensitive in diagnosis of thyroid autoimmune
diseases than anti-thyroglobulin (anti-TG) antibodies. However, in some cases anti-TG positive sera may
be negative for anti-TPO. Therefore, combined determination of both types of anti-thyroid antibodies
(anti-TPO + anti-TG) provides a more sensitive laboratory diagnostic tool for thyroid autoimmunity.


Sample type: serum, plasma                 Sensitivity: 5 IU/ml                                   Control sample: 1
Sample predilution: 1:101                     Incubation: 30’/30’/15’, RT                         Shelf life: 12 months
Sample volume: 100 μl                         Calibrators: 5 (0-1000 IU/ml)

 

K132 Thyroglobulin autoantobodies (anti-TG) EIA

Thyroglobulin (TG) is a well known target for autoantibodies occurring in thyroid autoimmunity
(Graves’ disease and Hashimoto’s thyroiditis). Anti-TG antibodies mostly belong to the IgG class.
Low to moderate levels of anti-TG antibodies can be found in sera of other autoimmune patients (eg
systemic lupus erythematosus or Sjogren syndrom). In some cases anti-TG positive sera may show
negativity for other type of anti-thyroid antibodies - anti-TPO. Therefore, combined determination of
both types of anti-thyroid antibodies (anti-TPO + anti-TG) provides most sensitive laboratory diagnostic
tool for thyroid autoimmunity. Separately from autoimmunity, anti-TG antibodies may develop in
patients suffering from thyroid cancer. High level of anti-TG in such patients may interfere with correct
determination of serum thyroglobulin which serves as tumor marker for therapy control in this group
of patients.


Sample type: serum, plasma                 Sensitivity: 10 IU/ml                                 Control sample: 1
Sample predilution: 1:101                     Incubation: 30’/30’/15’, RT                         Shelf life: 12 months
Sample volume: 100 μl                         Calibrators: 5 (0-3000 IU/ml)

 

 

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Last modified: 05/29/09