One Step TSH Whole Blood/Serum Combo Cassette
Test
A rapid chromatographic immunoassay for the detection of thyroid
stimulating hormone in infant human serum or whole blood.
NAME AND INTENDED USE
One Step TSH Serum Cassette Test for Infants is a colloidal gold/antibody complex
based immunoassay designed for the qualitative determination of thyroid stimulating
hormone (TSH) in serum. It is intended for professional use as an aid in the diagnosis of
hypothyroidism as well as to monitor response to therapy in babies.
SUMMARY AND EXPLANATION OF THE TEST
In normal infants, thyroid releasing hormone (TRH) from the hypothalmus stimulates the
release of thyroid stimulating hormone (TSH) from the pituitary gland. In turn, TSH
stimulates the release of thyroid hormones T3 and T4, which (by a negative feedback
system) stops the release of TRH. Thus, measuring the level of TSH in the serum is a
useful way to determine if the thyroid gland is functioning properly.
A TSH concentration higher than 3 ng/mL(15uIU/mL) in infants is indicative of
hypothyroidism. The One Step TSH Serum Cassette Test for Infants is very sensitive,
and able to detect 1 ng/mL of TSH and higher, making it an easy way to diagnose
hypothyroidism. If left untreated in babies, deficiency of thyroid hormone results in
mental retardation and stunted growth
PRINCIPLES OF THE PROCEDURE
The One Step TSH Serum Cassette Test for Infants consists of a chromatographic
absorbent device and a unique combination of monoclonal antibodies that selectively
detect TSH in test samples with a high degree of sensitivity. In fifteen minutes, levels of
TSH as low as 1 ng/ml are detected.
Whole Blood/Serum migrates through the absorbent area and along the test membrane.
TSH present in the specimen is bound by antibody-dye conjugate forming antibodyantigen complex. The complex is captured by anti-TSH antibody immobilized in the test
ZONE(T) of the membrane forming a pink-rose band ( in the absence of TSH, no line
will form in the test ZONE). Dye conjugate is captured by the antibody immobilized in
the control ZONE(C) of the membrane, producing pink-rose color.
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TEST STORAGE
Store the test below 28 oC, do not freeze. Prior to use bring test and components to room
temperature.
WARNINGS AND PRECAUTIONS FOR USERS
1. Handling should preclude any pipetting by mouth.
2. Do not allow smoking or eating where specimens and reagents are being handled.
3. Wear disposable gloves while handling kit reagents or specimens. Wash hands
thoroughly afterwards.
4. Avoid splashing or aerosol formation.
5. Clean up spills thoroughly using an appropriate intermediate-to high level
disinfectant.
6. Decontaminate and dispose of all specimens and potentially contaminated materials
as if they were infectious.
7. Do not use reagents after the expiration date.
8. For in vitro diagnostic use only.
QUALITY CONTROL
The use of controls (positive control at 1 ng/ml and negative control at 0ng/ml of TSH) is
recommended to verify proper kit performance. Quality control samples should be tested
according to quality control requirements established by the testing laboratory.
Use the control in the same manner as a specimen by following the test procedure.
TEST PROCEDURE
NOTE: In order to get an accurate result, it is necessary to run a cassette in a standard
with a TSH concentration of 1 ng/mL along with the test sample.
1. Bring test components including serum or whole blood to room temperature. Remove
test cassette from the pouch.
2. Add 120uL of serum or whole blood into the sample well.*
3. Read results at fifteen minutes
* For neonatal TSH test one drop (25~30ul) of baby's blood is added to sample well
followed by addition of three drops of chase buffer to same well.
INTERPRETATION OF RESULTS
A positive or negative result is determined by comparing the color intensity of the
test line with that of the cassette run in the 1 ng/mL TSH standard.
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a. POSITIVE: The test band is equal to or darker than the test band of the cassette run in
the 1 ng/mL TSH standard. The color intensity of the test band reflects the concentration
level of TSH.(3ng/ml for Neonatal TSH Test)
b. NEGATIVE: The test band's color intensity is lighter than the cassette run in the 1
ng/mL TSH standard, meaning that the TSH level is below the 1 ng/ml cutoff.
c. INVALID: If there is no rose-color band visible in the control window, then the test
result is invalid. It is recommended that the specimen be retested.
IMPORTANT: A positive result will not change once established at ten minutes.
However, in order to prevent any incorrect results, do not interpret results after fifteen
minutes.
References:
1. Bowen, R. Thyroid and Parathyroid Glands, Pathophysiology of the Endocrine
System. 20 Sept. 1998
<http://arbo.cvmbs.colostate.edu/hbooks/pathphys/endocrine/thyroid/index.html>
2. Thyroid Stimulating Hormone. Macromol Online. 21 Jan. 1999
<http://macromolonoine.8m.com/endo/hormones/tsh.htm>
3. Martel, J., Despres, N., Ahnade, C., Lachance, J., Monticello, J., Fink, G.
Ardemagni, A Ganfi, G., Tovey., Dykes, P., John, R. , Feffery, J., Grant, A.
Comparative Multicentre Study of a Panel of Thyroid Tests Using Different
Automated Immunoassay Platforms and Specimens at High Risk of Antibody
Interference. Clin Chem Lab Med 2000; 38(8): 785-793
4. Kopp, p. Human Genome and Diseases: Review The TSH Receptor and its Role
in Thyroid Disease. Cell Mol Life Sci 2001; 58:1301-1322
5. Billson, V. et al. Manual of Use and Interpretation of Pathology Tests: 3rd
Edition. Royal College of Pathologists of Austratlia 2001 Sydney.
<http://www.rcpa.edu.au/pathman/thyroid6.htm>
6. Panesar, N. S., Li, C. Y., Rogers, M. S. Reference Intervals for Thyroid
Hormones in Pregnant Chinese Women. Ann Clin Biochem 2001; 38:329-332
7. Rafferty, B., Das, R. G. Comparison of Pituitary and Recombinant Human
Thyroid-Stimulating Hormone(rhTSH) in a Multicenter Collaborative Study:
Establishment of the First World Health Organization Reference Reagent for rh
TSH. Clinical Chemistry 1999; 45(12): 2207-2215
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