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TSH Test

Measure TSH levels with reliable digital precision.

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Only for Professional Use
The Welleo TSH test quantitatively measures thyroid‑stimulating hormone levels using fluorescence immunoassay technology to support assessment of thyroid function.
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Technical product

TSH Test

Description

Thyroid-stimulating hormone (TSH), also called thyrotropin, is a glycoprotein hormone secreted by the anterior pituitary gland. TSH regulates thyroid gland activity by binding to receptors on thyroid follicular cells and stimulating the synthesis and release of thyroxine (T4) and triiodothyronine (T3). Its secretion is controlled by hypothalamic thyrotropin-releasing hormone (TRH) and by negative feedback from circulating thyroid hormones.

Because circulating TSH responds sensitively to changes in thyroid hormone availability, quantitative TSH measurement is widely used as an aid in the functional assessment of the thyroid axis. Increased TSH concentrations are commonly associated with reduced thyroid hormone production, while decreased TSH concentrations may be seen with increased thyroid hormone activity or altered pituitary/hypothalamic regulation. TSH results should be interpreted together with clinical findings and, when appropriate, companion thyroid tests such as free T4 and free T3.

Normal reference values: 0.30-4.20 ?IU/mL

Notice: Individual reference range is suggested to be established for each laboratory.

Intended use

Thyroid Stimulating Hormone Assay Kit (Immunochromatographic Assay) is intended for quantitative determination the Thyroid Stimulating Hormone (TSH) content in human serum, plasma, and whole blood in vitro.

Fluorescence immunoassay.

An aid in the functional diagnosis of thyroidea.

For in vitro diagnostic use only. For professional use only.

Principle

The test uses a TSH antibody to conjugate the fluorescent latex particles and another TSH antibody to coat the test line. After the sample has been applied to the working buffer, TSH combines with the antibody to form an antigen-antibody-particle complex, when mixed sample was applied to the testing card, the complex moves to the detection zone by capillary effect. The complex combines with antibody that coated on test line, forming a sandwich complex. The fluorescence intensity of the test line increases in proportion to the amount of TSH in sample.

Normal reference values: 0.30-4.20 μIU/mL

Notice:Individual reference range is suggested to be established for each laboratory.

Technical dossier

Laboratory and clinical details

Materials provided
  • Main components (ref. SF110255, SF110256, SF110257):
  • The product is mainly composed of the following items:
  • Test cartridge | 15 tests | Detector Buffer | 15 units | Whole blood sampler | 15 units | Lancet | 15 units | Alcohol pad | 15 units | Biohazard bag 15 units | Instructions for use | 1 unit |
  • Note: The components of the different batches of kits are not interchangeable.
  • Materials needed but not provided:
  • - Welleo Lateral Flow Reader (ref. Q1A-DUO-USB)
  • - Transfer pipette
  • - Sample Collection Containers
Materials needed but not provided
  • - Welleo Lateral Flow Reader (ref. Q1A-DUO-USB)
  • - Centrifuge (for Plasma/Serum only)
  • - Transfer pipette set (100 μL size)
  • - Specimen Collection Containers
Sample collection and preparation
  1. The test can be performed using serum, plasma, whole blood, or peripheral blood specimens.
  2. Whole Blood Collected by Venipuncture
  3. - Collect a whole blood specimen via venipuncture using standard phlebotomy procedures. Use a blood collection tube containing a suitable anticoagulant (EDTA is recommended).
  4. - It is recommended to test specimens immediately after collection. Do not leave specimens at room temperature for extended periods. If immediate testing is not possible, specimens may be stored at 2°C to 8°C.
  5. - Whole blood specimens stored at 2°C to 8°C for more than 2 days are not suitable for testing.
  6. Serum and Plasma
  7. - Separate serum or plasma from the blood as soon as possible to avoid hemolysis.
  8. - Testing should be performed immediately after specimen collection. Do not leave specimens at room temperature for extended periods.
  9. - Specimens may be stored at 2°C to 8°C for up to 7 days. For long-term storage, specimens should be kept at below –20°C.
  10. Peripheral Blood
  11. - Clean the fingertip with an alcohol pad. Remove the lancet cap and press to puncture the skin. Gently squeeze the finger to obtain an adequate drop of blood, then collect the sample into the blood collection tube.
  12. - Peripheral blood specimens may be stored at 2°C to 8°C for up to 7 days. For long-term storage, specimens should be kept at below –20°C.
Storage and stability
  • 1. The test should be stored at 2°C ~ 30°C until the expiration date, valid for 24 months. Do not freeze.
  • 2. Keep away from direct sunlight, moisture, and heat.
  • 3. Do not remove the test from the foil bag until you use it.
  • 4. The test must be used within one hour of opening.
Test procedure
  1. Download the app from the Google Play Store or Apple Store and sign in with your credentials. If sign up is needed, please contact your distributor. For specific operation of the instrument, follow the instructions on the reader.
  2. Step 1: Preparation
  3. The test and blood sample should be balanced at room temperature before the test. Open the foil bag, take out the test card, and place it on a table.
  4. Press “+” button to start a new test, scan the QR code located in the test and follow the procedure. Select Patient ID, Sample ID, and sample type (if applicable).
  5. Step 2: Sampling
  6. Extract 20 μL of whole blood, serum, or plasma with a transfer pipette and add it to the sample buffer tube. If using whole blood sampler open the diluent tube by peeling off the foil at the top and insert the blood collector completely into the diluent liquid.
  7. Step 3: Mixing
  8. Close the lid of the sample buffer tube and mix the sample well by shaking it about 10 times.
  9. Step 4: Loading
  10. Pipet 75 μL of sample mixture and load it into the test sample well. If using the whole blood sampler, place 2 drops in the sample well.
  11. Paso 5: Testing
  12. Press Start Timer button and wait for the 15 minutes reaction time. A timer will be displayed on screen. The Welleo shall be connected to the Mobile App before this timer has expired.
  13. Insert the test into the Welleo. Once inserted, the animation on the Welleo App will change and you will be requested to extract the test at a constant speed. After some seconds, the test result will be displayed. If asked to repeat the reading, follow the feedback warning for proper action. If the test is not processed within 1 minute after the countdown concludes, the test will be considered invalid, and a new test must be used for retesting.
Quality control
  • This product used in conjunction with the Welleo Lateral Flow Reader contains internal control for routine quality control requirements. This internal control is carried out every time a patient sample is analyzed. This check indicates whether the test cartridge was inserted and read correctly using the Lateral Flow Reader. An invalid internal control result causes an error message in the analyzer indicating that the test should be repeated.
Performance characteristics
  • 1. Limit of blank: ≤0.10μIU/mL .
  • 2. Accuracy: ±15.0%.
  • 3. Linearity: 0.10μIU/mL, 100.00μIU/mL, R≥0.99
  • 4. Repeatability: CV≤ 15.0 %.
  • 5. Difference between batches: CV ≤ 15.0 %.
Precautions
1. This kit is for in vitro diagnostic use only. Do not swallow.

2. Do not mix components from different kit lots.

3. Do not use test kit beyond the expiration date.

4. . Welleo Thyroid stimulating hormone Assay kit is operational in the Welleo Lateral Flow Reader, and tests should be applied by professionally trained staff.

5. The test cartridge should remain in its original sealed pouch until ready to use. Do not use the test cartridge if the pouch is punctured or not well sealed. Discard after single use.

6. The test cartridge and reader should be used away from vibration and magnetic field. During normal usage, the test cartridge may introduce minute vibration, which should be regarded normal.

7. Use separate clean pipette tips and detector buffer vials for different specimens. The pipette tips and detector buffer vials should be used for one specimen only. Discard after single use.

8. Do not smoke, eat, or drink in areas in which specimens or kit reagents are handled.

9. Blood specimens, used test cartridges, pipette tips and detector buffer vials are potentially infectious. Proper laboratory safety techniques, handing and disposal methods should be followed in accordance with standard procedures and relevant regulations observed by microbiological hazard materials.

10. The results should be interpreted by the healthcare professional along with clinical findings and other laboratory test results.

11. The test will be applied on a routine basis and not in emergency situations.
Limitations
1. This test has been developed for testing human whole blood, serum, plasma specimen only.

2. The results of the Welleo Thyroid Stimulating Hormone Rapid Test Kit should be evaluated with all clinical and laboratory data available. If TSH test results do not agree with the clinical evaluation, additional tests should be performed.

3. The false positive results include cross-reactions with some components of serum from individual to antibodies; and non-specific adhesion of some components in human blood that have similar epitopes to capture and detector antibodies. In the case of false negative results, the most common factors are: non-responsiveness of antigen to the antibodies by that certain unknown components are masking its epitope, such that antigen cannot be seen by the antibodies; instability of TSH antigen, resulting in degradation with time and, or temperature, such that they become no longer recognizable by antibodies; and degraded other test components. The effectiveness of the test is highly dependent on storage of kits and sample specimens at optimal conditions.

4. Plasma using anticoagulants (e.g. heparin or citrate) other than EDTA has not been evaluated in the Welleo TSH Rapid Quantitative Test and thus should not be used.

5. Other factors may interfere with the Welleo Thyroid Stimulating Hormone Rapid Test and may cause blood specimens.

How to use the Welleo tests