Product of the Month
Thyroid ELISA Line November / December 2008 + January 2009
Product of the Month
Thyroid ELISA Line Extensive Range of ELISA Tests HUMAN offers one of the broadest ELISA panels for the diagnosis of thyroid disorders, including tests for the determination of:
> thyroid status (T4, fT4, T3, fT3) > regulation of thyroid gland function (TSH) > causes of thyroid disorders by differentiation of all autoimmune diseases (Tg-Ab, TPO-Ab, TR-Ab)
NEW
Thyroid Gland and Disorders +++ hormones regulate body function +++ hypothyroidism +++ hyperthyroidism +++ The influence of the thyroid gland is both far-reaching and critical to normal body functioning. It affects heart rate, cholesterol level, body weight, energy level, muscle strength, skin condition, vision, menstrual regularity, mental state and a host of other aspects. Despite its pervasive influence, however, the thyroid gland and its disorders are still not widely understood among the general public. The thyroid, a butterfly shaped gland, produces hormones that regulate the body‘s metabolism and organ function. Thyroid hormones influence essentially every organ and every type of cell and tissue in the body. The most common thyroid disorder is an underactive thyroid, or hypothyroidism. This results when the thyroid fails to produce enough hormones. Less frequently, an overactive thyroid condition, or hyperthyroidism, occurs when the thyroid produces more thyroid hormones than are needed. If properly treated, patients with thyroid disorders lead normal, active lives. When left untreated, however, thyroid disorders can affect the patient‘s cardiovascular system, reproductive system and other major organs.
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Thyroid ELISA Line Thyroid Hormones and REgulation +++ feedback mechanism +++ thyroid gland - pituitary - other organs +++ The thyroid gland operates as part of a feedback mechanism involving the hypothalamus and the pituitary gland. First, the hypothalamus sends a signal to the pituitary gland through a hormone called TRH (thyrotropin releasing hormone). When the pituitary gland receives this signal, it releases TSH (thyroid stimulating hormone) to the thyroid gland. Upon receiving TSH, the thyroid responds by releasing two of its own hormones, T4 and T3, which then enter the bloodstream and affect the metabolism of the heart, liver, muscle and other organs. T4 is the main hormone released by the thyroid. T3 is made in the tissue after T4 to T3 conversion. Finally, the pituitary „monitors“ the level of thyroid hormone in the blood and increases or decreases the amount of TSH released, which then changes the amount of thyroid hormone in the blood.
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Thyroid ELISA Line Hypothyroidism +++ Underactive thyroid +++ Hashimoto‘s disease +++ risk factor for thyroid cancer +++ The most common type of thyroid disorder, hypothyroidism (underactive thyroid) occurs when the thyroid gland fails to produce enough thyroid hormones -- hormones which influence essentially every organ, every tissue and every cell in the body. Hypothyroidism affects particularly women and the elderly. 11% of Americans > 65 years of age exhibit hypothyroidism. Careful monitoring of thyroid hormone therapy is needed to prevent thyroid cancer. TSH is a risk factor for thyroid cancer in Hashimoto‘s. High TSH can stimulate latent cancer to grow. Characteristics
TSH elevated T4 and fT4 decreased T3 and fT3 decreased
Clinical Signs and Symptoms
In the case of mild thyroid failure, patients often do not show obvious symptoms and thus may not even be aware of their condition. Left untreated, however, mild thyroid failure can progress to where symptoms begin to surface. Some of the signs and symptoms of hypothyroidism include:
> Fatigue > Hoarse voice > Mood swings > Difficulty swallowing > Forgetfulness > Intolerance to cold > Dry, coarse skin and hair Causes
Hashimoto‘s disease lodine deficiency Therapeutic ablation (after surgery, radioiodine treatment)
Hashimoto‘s disease the most common type of hypothyroidism and the most frequent human autoimmune disease is a condition caused when the immune system produces killer lymphocytes that destroy the thyroid. As the damaged thyroid gland produces less of the thyroid hormones, the pituitary gland secretes more thyroid-stimulating hormone (TSH) to encourage the thyroid to work harder. This increased demand on the thyroid may cause it to enlarge, resulting in what is commonly known as a goiter. Antibodies are produced that are detectable with a diagnostic test for autoimmune disease.
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Thyroid ELISA Line Hyperthyroidism +++ Overactive thyroid +++ Graves‘ Disease +++ Hyperthyroidism, a less common thyroid disorder, occurs when the thyroid gland becomes overactive and produces too much thyroid hormone. It is more prevalent among women, particularly those in their 30s and 40s. In the U.S. it only affects approximately 2.5% of Americans > 65 years of age. Characteristics
TSH decreased T4 and fT4 elevated T3 and fT3 elevated
Clinical Signs and Symptoms
The spectrum of possible signs and symptoms resulting from an overactive thyroid includes:
> Irritability / nervousness > Sleep disturbances > Muscle weakness / tremors > Enlarged thyroid (goiter) > Irregular menstrual periods > Heat intolerance > Weight loss > Vision problems or eye irritation Causes
Graves‘ disease Thyroiditis Adenoma Carcinoma
Graves’ Disease (Morbus Basedow), the most common form of this disorder, is an autoimmune disease which is triggered by endogenous antibodies directed against the TSH receptor. By binding to the receptor they stimulate the production and secretion of additional thyroid hormones.
Product of the Month
Thyroid ELISA Line Significance of Diagnostic Assays +++ Untreated for years +++ New TSH reference range +++ Particularly hypothyroidism may be difficult to detect because its often vague signs and symptoms are easily confused with other conditions, such as the natural aging process, menopause or stress. Many patients remain undiagnosed and untreated for years due to their lack of awareness of hypothyroidism and its signs and symptoms. Fortunately, even mild hypothyroidism can be detected by TSH (thyroid stimulating hormone) testing, which enables physicians to identify thyroid disorders much earlier than with previous tests. By detecting hypothyroidism in its early stages, physicians may administer treatment and prevent the onset of symptoms. New data has caused a change in the normal TSH range. Hypothyroidism is likely if TSH is > 3.6 mIU/l.
Testing Strategy
I. Examination It is advised to perform a case history and clinical / physical examination before starting the determination of thyroid hormone levels. II. TSH Testing TSH is the leading indicator of thyroid gland failure; accordingly the testing strategy for determination of thyroid disorders is initially based on TSH.
Product of the Month
Thyroid ELISA Line Testing Strategy (continued) III. Confirmatory follow-up tests A) In case of reduced TSH levels (indicative for hyperthyroid disorders): A1) Thyroid Hormones - fT4 or - (total) T4 in combination with TBG (when changes in binding globulins expected) alternatively with: - fT3 or - (total) T3 in combination with TBG (when changes in binding globulins expected) A2) Autoimmune Antibodies - TPO Ab - TG Ab B) In case of TSH levels in the upper range of normal values or increased TSH levels (indicative for hypothyroid disorders): B1) Thyroid Hormones - fT4 or - (total) T4 in combination with TBG (when changes in binding globulins expected) B2) Autoimmune Antibodies - TRAB - TPO Ab
IV. Interpretation - The hormone level indicates the thyroid disorder Disorder Manifest Hyperthyroidism
Hormone
Level
Concentration
TSH
Low
< 0.1 mlU/l
fT4 (or T4)
High
> Ref. Range
fT3 (or T3)
High
> Ref. Range
Low
> 0.1 - < 0.3 mlU/l
TSH Subclinical Hyperthyroidism
Euthyroid
Subclinical Hypothyroidism
Manifest Hypothyroidism
fT4 (or T4)
Ref. Range
8 - 20 ng/l (44 - 108 µg/l)
fT3 (or T3)
Ref. Range
1.4 - 4.2 ng/l (0.7 - 2.0 µg/l)
TSH
Ref. Range
0.3 - 3.6 mlU/l
TSH
High
4 - 10 mlU/l
fT4 (or T4)
Ref. Range
8 - 20 ng/l (44 - 108 µg/l)
fT3 (or T3)
Ref. Range
1.4 - 4.2 ng/l (0.7 - 2.0 µg/l)
TSH
High
< 10 mlU/l
fT4 (or T4)
Low
< Ref. Range
fT3 (or T3)
Low
< Ref. Range
Product of the Month
Thyroid ELISA Line Intended Use and Characteristics of HUMAN ELISAs We have expanded our well known HUMAN thyroid panel with assays of the IMTEC ELISA line. We now offer new thyroid assays for the determination of autoimmune antibodies: Parameter
HUMAN ELISA Performance data
Cat. No.
TSH (Thyroid Stimulating Hormone) / Thyrotropin
TSH ELISA
54030
> Reflects the availabilty of thyroid
Functional Sensitivity
hormones in tissues
> The basic parameter for the thyroid testing strategy
> Important tool for therapeutic monitoring
< 0.1 mlU/l
(Sensitivity at CV ≤ 20%)
Measuring Range:
0 - 30 mlU/l
Sample Volume:
50 µl
Sample Type:
Serum
Free T4 / Free Thyroxine
fT4 ELISA
> Assessment of hormone secretion
Analytical Sensitivity
0.05 ng/dl
Measuring Range:
0 - 7.4 ng/dl
Sample Volume:
50 µl
Sample Type:
Serum
activity of thyroid gland.
(Only 0.02 - 0.03 % of T4 is available as free T4, thus it is the better parameter for diagnosis than T3, which is more frequently bound (0.2 - 0.3 %)).
> Measures the free, unbound thyro xine levels in bloodstream.
(It represents the level of hormone available for uptake and use by cells. The free level of T4 represents the hormone immediately available; accordingly free T4 better reflects the patient‘s hormonal status than total T4 (below).)
54025
> Today it is state-of-the-art and
common practice to test free T4.
Total T4 / Total Thyroxine / Serum Thyroxine
T4 ELISA
> Produced by the thyroid gland
Analytical Sensitivity
0.4 µg/dl
Measuring Range:
0 - 25 µg/dl
Sample Volume:
25 µl
Sample Type:
Serum Plasma
> Measures the amount of protein-
bound hormone circulating in blood stream
(The bound levels may not all be available immediately, they are not biologically active. It is affected by drugs, illness, and physical changes such as pregnancy.)
54020
Product of the Month
Thyroid ELISA Line Intended Use and Characteristics of HUMAN ELISAs (continued) Parameter
HUMAN ELISA Performance data
Cat. No.
Free T3 / Free Triiodothyronine
fT3 ELISA
54015
> Mainly indicated for the determina
Analytical Sensitivity
0.5 pg/ml
Measuring Range:
0 - 16 pg/ml
Sample Volume:
50 µl
Sample Type:
Serum
tion of hyperthyroidism in the case of normal fT4 and suppressed TSH, and for therapeutic monitoring
> Measures the free, unbound levels of triiodothyronine in the blood stream.
> Free T3 is considered more accurate than total T3 and reflects the stateof-the-art.
Total T3 / Total Triiodothyronine
T3 ELISA
> Produced by the thyroid gland
Analytical Sensitivity
0.05 ng/dl
Measuring Range:
0 - 7.5 ng/ml
Sample Volume:
50 µl
Sample Type:
Serum Plasma
> Measures the amount of protein-
bound hormone circulating in blood stream. (It is not biologically active, see as well T4)
54010
TPO Ab (Thyroid Peroxidase Antibodies) / Antithyroid Peroxidase Antibodies
IMTEC-TPO-Antibodies
> Counteracts thyroid peroxidase, an
Analytical Sensitivity
< 3 lU/ml
Measuring Range:
11.5 - 2930 lU/ml
Sample Volume:
100 µl
Sample Type:
Serum
enzyme involved in the T4-to-T3 conversion and synthesis process.
> Detectable in approximately 95 per
cent of patients with Hashimoto‘s thyroiditis, and 50 to 85 percent of Graves’ disease patients. The concen trations of antibodies found in patients with Graves‘ disease are usually lower than in patients with Hashimoto‘s disease.
(diluted 1:100)
ITC85020
NEW
Product of the Month
Thyroid ELISA Line Intended Use and Characteristics of HUMAN ELISAs (continued) Parameter
HUMAN ELISA Performance data
Cat. No.
TG Ab (Thyroglobulin Antibodies) / Antithyroglobulin Antibodies
IMTEC-TG-Antibodies
ITC85010
> Indicated particularly in cases of
Analytical Sensitivity
negative TPO Ab results.
> Positive in about 60 percent of
Measuring Hashimoto‘s patients and 30 percent Range: of Graves‘ patients. Sample Volume: Sample Type:
< 5.5 lU/ml
15 - 3840 lU/ml 100 µl
(diluted 1:100)
Serum
TRAb (TSH Receptor Antibodies)
IMTEC-TSH-Receptor Antibodies
> Binds to the TSH receptor of the thy
Analytical Sensitivity
0.21 lU/ml
Measuring Range:
0 - 40 lU/l
Sample Volume:
75 µl
Sample Type:
Serum
rocytes and acts as a TSH agonist
> Mimics TSH and increases the
production and secretion of thyroid hormones
NEW
ITC85030
NEW (available December 2008)
Product of the Month
Thyroid ELISA Line Marketing Aspects +++ High volume parameter +++ System business +++ Reagent rental Optimize your marketing and sales strategy! The expansion of the HUMAN thyroid panel through the addition of autoimmune assays provides an excellent opportunity. The intended use of HUMAN’s thyroid panel and the clinical testing strategy for the screening, monitoring and cause analysis of thyroid disorders make an automatic system the ideal solution. The HUMAN ELISYS automatic analyzer line offers: > Automation solutions to suit your customers‘ throughput requirements for the high volume parameter TSH. > Flexibility for follow-up examinations with HUMAN‘s comprehensive thyroid panel to cover individual patient‘s needs. Overall, this creates the perfect basis to help you implement our expand your reagent-rental business. Take this opportunity to invest in the growth of your ELISA system business!
Elisys Uno
Elisys Duo*
Elisys Quattro
HUMAN ELISYS automatic analyzers in order of increasing throughput from left to right.
* available end of 1st quarter 2009
