|
What It Is
CLIA 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 510(k) status and CLIA waiver for measuring above normal levels of thyroid stimulating hormone (TSH) in a rapid format. CPT code is 84443 or 84443 QW.
This simple rapid diagnostic test is a qualitative measurement that allows healthcare practitioner 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 five (5) 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 uIU/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 uIU/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.
|
|
|
|
|
|
|
|
|
|
|
 |
|
 |
|
 |
|
 |
|
 |
|
Negative |
|
Positive |
|
Positive |
|
Invalid |
|
Invalid |
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.
|
