"ThyroTest is an accurate diagnostic screening device that helps patients
with common hypothyroid symptoms such as fatigue, weight gain, loss of libido
and depression, gain vital diagnostic results in the best setting possible" –
the physician’s office.
Physicians and patients are no longer required to wait several days for their
lab results.
ThyroTest allows physicians to accurately detect abnormal / elevated levels (>
5µIU/mL) of TSH in 10 minutes.
Why ThyroTest?
- Studies estimate 13 million Americans are undiagnosed and needlessly
suffer from the treatable hypothyroidism disease.
- 1 out of every 8 American women will develop a thyroid disorder.
- It is estimated that 20% of all chronic depression cases are associated
with undiagnosed hypothyroidism.
1020 -
Wampole Laboratories ThyroTest TSH Test Kit, 20 Tests
What It Is
The function of the thyroid gland is to produce hormones that regulate the
body's metabolism. Hypothyroidism is when the thyroid gland does not produce
enough thyroid hormone, which regulates the way the body uses energy. A lack
of thyroid hormone affects many body systems.
When the thyroid produces too much of these hormones, the metabolism is too
fast and causes problems in many areas of the body. This is hyperthyroidism.
When the thyroid gland's production of hormones is less than normal, the
body's metabolism slows down and can cause reduced functionality of all
systems in the body. This is hypothyroidism.
Who It Effects
Hypothyroidism is much more common (about 10 to 1) than hyperthyroidism. Both
conditions have a strong genetic link. If someone in your family had "thyroid
problems" your chances of having thyroid disease is increased. Women are about
six times more likely to be hypothyroid than men. Hypothyroidism becomes more
prevalent as we age. Most patients are diagnosed after the age of 40, although
hypothyroidism can present at any age. It has been estimated in a recent study
that as many as 13 million Americans may have thyroid disease and not be aware
of it. Another study has estimated that over 15% of women over 65 years of age
are hypothyroid.
Symptoms of Hypothyroidism
>
Enlarged thyroid gland
>
Weight gain
>
Cold intolerance
>
Depression
>
Sluggishness, sleepiness
>
Slower reflexes
>
Brittle fingernails
>
Menstrual irregularities (heavier)
>
Muscular aches and cramps
>
Poor memory
>
Inability to concentrate
Treatment
Hypothyroidism is usually treated with a daily supplement of the hormone(s)
that the thyroid is failing to produce in adequate amounts. Periodic doctor
visits are required to maintain the dose at the correct level, as all patients
are different.
Most patients diagnosed with Hypothyroidism are able to live healthy normal
lives after beginning their daily regiment of thyroid therapy as prescribed by
their physician.
About ThyroTest
What It Is
FDA approved and CLIA Waived ThyroTest ® is a new rapid diagnostic screening
device used for initial detecting of hypothyroidism, a common thyroid disease.
This will allow for earlier detection for millions of Americans.
ThyroTest is the first, and only, product to receive FDA approval and CLIA
waiver for measuring above normal levels of thyroid stimulating hormone (TSH)
in a rapid format.
This simple rapid diagnostic test is a qualitative measurement that allows
physicians to review results for hypothyroidism in 10-Minutes with a whole
blood sample.
ThyroTest screens patients with symptoms of hypothyroidism by measuring the
level of TSH (thyroid stimulating hormone). It will yield a positive result if
the level of TSH is higher than 5 uIU/ml. This is the present day standard for
the upper limits of normal for TSH .
- No special training required (CLIA Waived)
- Easy to use screening test (physician’s office, clinic, health fair)
- 95.5% accurate
- Cost effective
- Quick results
- Read results in 10 minutes
How It Works
ThyroTest ® is a rapid immunoassay, similar to a rapid pregnancy test. By
using 2 drops of blood from a finger-stick and 5 drops of diluent, a
qualitative TSH level is indicated in minutes.
How Do I Use The ThyroTest ® Cassette?
- Remove the test cassette and pipette from the foil pouch by tearing a slot on
the side of bag. Do not remove the desiccant pack. Discard the pouch.
- Place the cassette on a hard flat surface with the window facing up.
- Add 2 drops of whole blood directly into Sample well on the Test Cassette with
the pipette provided in the pouch. Discard the pipette after use into a waste
container when done.
- Add six (6) drops of Test Buffer into the Sample well on the Test Cassette.
- Set a timer for 10 minutes. Do NOT move the cassette during this time.
- At the end of the 10 minutes, read the line(s) in the window of the cassette.
Do not move the cassette until you have checked the line(s).
Important
In order to prevent a wrong reading, do not read after 12 minutes.
Results
Negative: One pink/purple colored line appears in the rectangular window near
the Control mark. No colored line near the Test mark means the TSH level is
negative, and below the cut-off of 5 mIU/mL.
Positive: In addition to the pink/purple line by the Control mark, a second
pink/purple colored line seen near the Test mark means the TSH level is
positive, and above the cut-off of 5 mIU/mL
Invalid: A pink/purple line should always appear near the Control mark. If
there is no pink/purple line seen near the mark, the test is invalid. Do not
report the result. In this case the test should be repeated with a new
cassette or call 1-800-257-9525.
Please Note
Any Pink / Purple line that is seen near the Test mark of the cassette at the
10-minute time is considered a positive result. The intensity of the line does
not matter.
Reporting Results
The results of this test should be reported to a physician for individual
interpretation and managing the symptoms.