Download Thyroid Stimulating Hormone, 3rd Generation

References
1Spencer CA, Takeuchi M and Kazarosyan M. Current status and performance goals for serum thyrotropin (TSH) assays.
Clinical Chemistry 1996;42:141-145.
2Rawlins, ML, Roberts, WL Performance characteristics of six third-generation assays for thyroid stimulating hormone.
2004 Clin Chem 50:12 2338-2344.
3Evolution of TSH Assays: A Third Generation Viewpoint. Siemens monograph.
4The National Academy of Clinical Biochemistry: Laboratory Support for the Diagnosis and Monitoring of Thyroid Disease 2002.
Laurence M. Demers, Ph.D., F.A.C.B. and Carole A. Spencer Ph.D., F.A.C.B.
5Wardle CA, Fraser WD and Squire CR. Pitfalls in the use of thyrotropin concentration as a first-line thyroid-function test.
Lancet 2001;357:1013-4.
6Clinical dialysis Allen R. Nissenson, Richard N. Fine McGraw-Hill Professional, 2005, p 803-818.
7Handbook of dialysis, Volume 236 By John T. Daugirdas, Peter Gerard Blake, Todd S. Ing. Lippincott Williams & Wilkins,
Dec 1, 2006.
8 Spectra data.
9 Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, Eisevier, Inc., 4th edition, 2006, p 2062.
10 Henry’s Clinical Diagnosis and Management by Laboratory Methods, Saunders, 21st edition, 2007, p 341.
Spectra Laboratories, Inc.
525 Sycamore Drive • Milpitas, CA 95035 • 800-433-3773
8 King Road • Rockleigh, NJ 07647 • 800-522-4662
www.spectra-labs.com
Thyroid Stimulating
Hormone, 3rd Generation
© 2013 Fresenius Medical Care Holdings, Inc. All rights reserved.
Spectra and the Spectra logo are trademarks of Fresenius
Medical Care Holdings, Inc. or its affiliated companies.
All other trademarks are the property of their respective owners.
TSHBULLETIN Rev. 3/2013
DISTRIBUTION
OF TSH and FT4 IN THE DIALYSIS POPULATION
New Test: Thyroid Stimulating Hormone,
3rd Generation
TSH
1
0.0
Spectra will no longer offer the current TSH assay
because the new TSH3 assay provides the full
testing range required for the determination of both
hypothyroidism and hyperthyroidism. The American
0.1
Thyroid Association (ATA) currently suggests a third
generation TSH as the most cost effective strategy
to detect thyroid disease.4 Many clinicians pair
0.01
the TSH with FT4 to recognize euthyroid hyperor hypothyroxinemia. The latter is common in
nephrotic syndrome.5 TSH can also be helpful in
determining whether an elevated T4 is indicative
of hyperthyroidism or is due to decreased proteinbinding site availability.4
The benefit of TSH3 is that, unlike 2nd generation
TSH assays, TSH3 can measure levels below
0.020 mIU/L and can be used to distinguish the
extremely low levels of TSH suppression of Graves’
disease from the less severely suppressed TSH of
non-thyroid illnesses.4
Reference Range
According to the ATA, >95% of the normal
population will have a TSH level below 2.5 mIU/L
with an average TSH level of approximately 1.5
mIU/L.4 Spectra has validated a TSH reference
range of 0.300-3.000 mIU/L, which is also the range
recommended by the American Association of
Clinical Endocrinologists (AACE).
The ESRD population includes about 20% of
individuals with TSH of up to 20 mIU/L and a
normal free T4 consistent
with non-thyroidal illness.
Persistant TSH values over 20 mIU/L
usually indicitive of hypothyroid
ESRD patients with true are
hypothyroidism
develop
condition
persistent values above 20 mIU/L.
Although the average level of TSH in the general population is approximately 1.5 mIU/L, the mean TSH in the
dialysis population is higher, with a significantly greater variation, compared to the general population. Free
thyroid hormone can increase temporarily due to inflammation and following the administration of heparin
due to the competition for the carrier proteins binding sites.10
20% of dialysis patients have TSH levels
between 5-20 mIU/L and appear not to
be related to thyroid disease
DISTRIBUTION OF TSH and FT4 IN THE DIALYSIS POPULATION
TSH and the Dialysis Patient
The effects of uremia on dialysis patients are
Reference Ranges
sometimes indistinguishable from symptoms
of
Free T4: 0.89 - 1.76 ng/dL
6
TSH:
0.300-3.000
hypothyroidism. Peritoneal and hemodialysis do mIU/L
not directly affect the thyroid hormone levels, but
0.5
1.0 in peritoneal
1.5
2.0 lead to 2.5
a loss of protein
dialysis can
a decrease in the total thyroxin levels.7 Dialysis
patients may have decreased FT3 and FT4, and
increased TSH levels and still be euthyroid.6
Abnormal thyroid results in dialysis patients
are more commonly due to abnormal protein
levels, malnutrition, or non-thyroid intercurrent
illnesses than to actual thyroid dysfunction.6
Although decreases in thyroid hormones are
generally associated with non-thyroid disease and
malnutrition, dialysis patient decreases in FT3 are
also due to decreased ability to convert FT4 to FT3
at the cellular level.9
1000
FT4
3.0
Persistant TSH values over 20 mIU/L
are usually indicitive of hypothyroid
condition
100
20% of dialysis patients have TSH levels
between 5-20 mIU/L and appear not to
be related to thyroid disease
10
Reference Ranges
Free T4: 0.89 - 1.76 ng/dL
TSH: 0.300-3.000 mIU/L
TSH
1000
Spectra Laboratories is pleased to announce
the addition of a new test, 3rd Generation
Thyroid Stimulating Hormone (TSH3). This 3rd
100 TSH
Generation TSH assay will replace the current
assay. TSH3 provides a tenfold improvement in
sensitivity over the previous method. In order to
be designated a 3rd Generation TSH assay, a TSH
10
method must have a functional sensitivity below
1,2
a 0.020 mIU/L. The detectable limit of Spectra
Laboratories’ new 3rd Generation TSH assay has a
functional level validated to 0.008 mIU/L.3
1
0.0
0.5
1.0
1.5
2.0
2.5
FT4
3.0
DIALYSIS VS NON DIALYSIS THYROID HORMONES
9.00
8.64
8.00
7.00
FT4:
FT3:
6.00
TSH:
LITTLE DIFFERENCE
DECREASED IN DIALYSIS POPULATION
IMPAIRED CONVERSION OF FT4 TO FT3
DECREASED THYROID HORMONE INCREASES TSH
5.00
4.72
4.00
3.00
3.20
2.00
1.00
0.00
2.10
1.13
0.1
1.14
FT4
FT3
TSH
NON DIALYSIS
1.13
3.20
4.72
DIALYSIS
1.14
2.10
8.64
0.01
These relatively mild decreases in FT3 and FT4 levels are not usually related to hypothyroidism but may,
in part, contribute to the moderately increased TSH as compared to the normal population. Factors related
to non-thyroid disease and the dialysis process result in 19-20% of dialysis patients having levels of TSH
between 5 and 20 mIU/L.7,8 However, repeatedly decreased levels of FT4 and elevated TSH levels greater
than 20 mIU/L may be indicative of true hypothyroidism.6,7 In addition, because of the prevalence of diabetes
in the dialysis population, the incidence of primary hypothyroidism is increased (4%) in the ESRD population
when compared to the normal population.6
DIALYSIS VS NON DIALYSIS THYROID HORMONES
The new TSH3 assay provides the full testing range required for the
determination of both hypothyroidism and hyperthyroidism.
Reference Range: 0.300-3.000 mIU/L
9.00
Factors related to non-thyroid
disease and the dialysis process result in
8.64
19-20% of dialysis patients
having levels of TSH between 5 and
20 mIU/L.7,8
8.00
However, repeatedly decreased
of FT4 and elevated TSH levels greater
FT4: levels
LITTLE DIFFERENCE
7.00
FT3:
DECREASED IN DIALYSIS POPULATION 6,7
than 20 mIU/L may be indicative IMPAIRED
of trueCONVERSION
hypothyroidism.
OF FT4 TO FT3
6.00
5.00
TSH:
DECREASED THYROID HORMONE INCREASES TSH
DISTRIBUTION
OF TSH and FT4 IN THE DIALYSIS POPULATION
New Test: Thyroid Stimulating Hormone,
3rd Generation
TSH
0.0
Spectra will no longer offer the current TSH assay
because the new TSH3 assay provides the full
testing range required for the determination0.1of both
hypothyroidism and hyperthyroidism. The American
Thyroid Association (ATA) currently suggests a third
generation TSH as the most cost effective strategy
to detect thyroid disease.4 Many clinicians0.01
pair
the TSH with FT4 to recognize euthyroid hyperor hypothyroxinemia. The latter is common in
nephrotic syndrome.5 TSH can also be helpful in
determining whether an elevated T4 is indicative
of hyperthyroidism or is due to decreased proteinbinding site availability.4
The benefit of TSH3 is that, unlike 2nd generation
TSH assays, TSH3 can measure levels below
0.020 mIU/L and can be used to distinguish the
extremely low levels of TSH suppression of Graves’
disease from the less severely suppressed TSH of
non-thyroid illnesses.4
Reference Range
According to the ATA, >95% of the normal
population will have a TSH level below 2.5 mIU/L
with an average TSH level of approximately 1.5
mIU/L.4 Spectra has validated a TSH reference
range of 0.300-3.000 mIU/L, which is also the range
recommended by the American Association of
Clinical Endocrinologists (AACE).
The ESRD population includes about 20% of
individuals with TSH of up to 20 mIU/L and a
normal free T4 consistent
with non-thyroidal illness.
Persistant TSH values over 20 mIU/L
usually indicitive of hypothyroid
ESRD patients with true are
hypothyroidism
develop
condition
persistent values above 20 mIU/L.
Although the average level of TSH in the general population is approximately 1.5 mIU/L, the mean TSH in the
dialysis population is higher, with a significantly greater variation, compared to the general population. Free
thyroid hormone can increase temporarily due to inflammation and following the administration of heparin
due to the competition for the carrier proteins binding sites.10
20% of dialysis patients have TSH levels
between 5-20 mIU/L and appear not to
be related to thyroid disease
DISTRIBUTION OF TSH and FT4 IN THE DIALYSIS POPULATION
TSH and the Dialysis Patient
The effects of uremia on dialysis patients are
Reference Ranges
sometimes indistinguishable from symptoms
of
Free T4: 0.89 - 1.76 ng/dL
6
TSH:
0.300-3.000
hypothyroidism. Peritoneal and hemodialysis do mIU/L
not directly affect the thyroid hormone levels, but
0.5
1.0 in peritoneal
1.5
2.0 lead to 2.5
a loss of protein
dialysis can
a decrease in the total thyroxin levels.7 Dialysis
patients may have decreased FT3 and FT4, and
increased TSH levels and still be euthyroid.6
Abnormal thyroid results in dialysis patients
are more commonly due to abnormal protein
levels, malnutrition, or non-thyroid intercurrent
illnesses than to actual thyroid dysfunction.6
Although decreases in thyroid hormones are
generally associated with non-thyroid disease and
malnutrition, dialysis patient decreases in FT3 are
also due to decreased ability to convert FT4 to FT3
at the cellular level.9
1000
FT4
3.0
Persistant TSH values over 20 mIU/L
are usually indicitive of hypothyroid
condition
100
20% of dialysis patients have TSH levels
between 5-20 mIU/L and appear not to
be related to thyroid disease
10
Reference Ranges
Free T4: 0.89 - 1.76 ng/dL
TSH: 0.300-3.000 mIU/L
TSH
1000
Spectra Laboratories is pleased to announce
the addition of a new test, 3rd Generation
Thyroid Stimulating Hormone (TSH3). This 3rd
100
Generation TSH assay will replace the current
TSH (Highly Sensitive) assay. TSH3 provides a
tenfold improvement in sensitivity over the previous
method. In order to be designated a 3rd Generation
10
TSH assay, a TSH method must have a functional
1,2
sensitivity below a 0.020 mIU/L. The detectable
limit of Spectra Laboratories’ new 3rd Generation
TSH assay has a functional level validated to 0.008
1
mIU/L.3
1
0.0
0.5
1.0
1.5
2.0
2.5
FT4
3.0
DIALYSIS VS NON DIALYSIS THYROID HORMONES
9.00
8.64
8.00
7.00
FT4:
FT3:
6.00
TSH:
LITTLE DIFFERENCE
DECREASED IN DIALYSIS POPULATION
IMPARIED CONVERSION OF FT4 TO FT3
DECREASED THYROID HORMONE INCREASES TSH
5.00
4.72
4.00
3.00
3.20
2.00
1.00
0.00
2.10
1.13
0.1
1.14
FT4
FT3
TSH
NON DIALYSIS
1.13
3.20
4.72
DIALYSIS
1.14
2.10
8.64
0.01
These relatively mild decreases in FT3 and FT4 levels are not usually related to hypothyroidism but may,
in part, contribute to the moderately increased TSH as compared to the normal population. Factors related
to non-thyroid disease and the dialysis process result in 19-20% of dialysis patients having levels of TSH
between 5 and 20 mIU/L.7,8 However, repeatedly decreased levels of FT4 and elevated TSH levels greater
than 20 mIU/L may be indicative of true hypothyroidism.6,7 In addition, because of the prevalence of diabetes
in the dialysis population, the incidence of primary hypothyroidism is increased (4%) in the ESRD population
when compared to the normal population.6
DIALYSIS VS NON DIALYSIS THYROID HORMONES
The new TSH3 assay provides the full testing range required for the
determination of both hypothyroidism and hyperthyroidism.
Reference Range: 0.300-3.000 mIU/L
9.00
Factors related to non-thyroid
disease and the dialysis process result in
8.64
19-20% of dialysis patients
having levels of TSH between 5 and
20 mIU/L.7,8
8.00
However, repeatedly decreased
of FT4 and elevated TSH levels greater
FT4: levels
LITTLE DIFFERENCE
7.00
FT3:
DECREASED IN DIALYSIS POPULATION 6,7
than 20 mIU/L may be indicative IMPARIED
of trueCONVERSION
hypothyroidism.
OF FT4 TO FT3
6.00
5.00
TSH:
DECREASED THYROID HORMONE INCREASES TSH
References
1Spencer CA, Takeuchi M and Kazarosyan M. Current status and performance goals for serum thyrotropin (TSH) assays.
Clinical Chemistry 1996;42:141-145.
2Rawlins, ML, Roberts, WL Performance characteristics of six third-generation assays for thyroid stimulating hormone.
2004 Clin Chem 50:12 2338-2344.
3Evolution of TSH Assays: A Third Generation Viewpoint. Siemens monograph.
4The National Academy of Clinical Biochemistry: Laboratory Support for the Diagnosis and Monitoring of Thyroid Disease 2002.
Laurence M. Demers, Ph.D., F.A.C.B. and Carole A. Spencer Ph.D., F.A.C.B.
5Wardle CA, Fraser WD and Squire CR. Pitfalls in the use of thyrotropin concentration as a first-line thyroid-function test.
Lancet 2001;357:1013-4.
6Clinical dialysis Allen R. Nissenson, Richard N. Fine McGraw-Hill Professional, 2005, p 803-818.
7Handbook of dialysis, Volume 236 By John T. Daugirdas, Peter Gerard Blake, Todd S. Ing. Lippincott Williams & Wilkins,
Dec 1, 2006.
8 Spectra data.
9 Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, Eisevier, Inc., 4th edition, 2006, p 2062.
10 Henry’s Clinical Diagnosis and Management by Laboratory Methods, Saunders, 21st edition, 2007, p 341.
Spectra Laboratories, Inc.
525 Sycamore Drive • Milpitas, CA 95035 • 800-433-3773
8 King Road • Rockleigh, NJ 07647 • 800-522-4662
www.spectra-labs.com
Thyroid Stimulating
Hormone, 3rd Generation
© 2013 Fresenius Medical Care Holdings, Inc. All rights reserved.
Spectra and the Spectra logo are trademarks of Fresenius
Medical Care Holdings, Inc. or its affiliated companies.
All other trademarks are the property of their respective owners.
TSHBULLETIN Rev. 3/2013