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Cortisol Test

Track cortisol levels with quantitative, data‑based results.

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Only for Professional Use
The Welleo Cortisol test quantitatively measures cortisol levels to help assess stress response and adrenal function. Fluorescence detection and digital analysis provide clear, objective hormonal data.
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Technical product

Cortisol Test

Description

Cortisol is a steroid hormone classified as a glucocorticoid, primarily synthesized in the zona fasciculata of the adrenal cortex. Approximately 90% of circulating cortisol is bound to corticosteroid-binding globulin (CBG), while 5–10% exists as free cortisol and is excreted in the urine.

Cortisol plays a vital role in maintaining physiological homeostasis and is essential for the metabolism of proteins, fats, and carbohydrates. During stress responses, cortisol is rapidly released into the bloodstream to help stabilize blood glucose levels and blood pressure.

Excess cortisol production may result in Cushing’s syndrome, which typically presents with central obesity, moon-shaped face, purple striae on the lower abdomen and inner thighs, facial redness, menstrual irregularities or amenorrhea in women, and reduced libido in men. Conversely, cortisol deficiency may lead to Addison’s disease, characterized by fatigue, weight loss, poor appetite, hypoglycemia, hypotension, and skin hyperpigmentation.

Measuring cortisol levels in serum or plasma is clinically valuable for diagnosing adrenal gland disorders such as Cushing’s syndrome and Addison’s disease, and for monitoring treatment efficacy. Cortisol secretion is closely linked to adrenal gland function and significantly influences water-salt balance and metabolic processes.

The reference range for cortisol was established by testing samples from apparently healthy individuals. The results are as follows:

Group | n | 95% Reference Range (nmol/L) | Healthy adults | 275 | 185–624

Please note that expected values may vary depending on factors such as age, sample type, diet, and geographical location. Each laboratory is advised to verify the applicability of these reference values to its own patient population and, if necessary, establish its own reference ranges in accordance with good laboratory practices.

Intended use

The Welleo Cortisol Assay Kit is intended for the quantitative in vitro determination of cortisol concentrations in human serum and plasma. It is primarily used as an auxiliary tool in the evaluation of adrenal cortex function. This test is designed for professional use in clinical laboratories only.

Principle

The Cortisol Fast Test Kit (Immunofluorescence Assay) is based on a competitive lateral flow immunoassay design. Once the sample is applied to the test strip, fluorescent latex-labeled monoclonal antibodies specific to cortisol bind to the cortisol present in the sample, forming a labeled antigen-antibody complex.

Any unbound fluorescent antibodies then interact with the immobilized cortisol antigen on the test line. As a result, the fluorescence intensity of the test line decreases proportionally to the concentration of cortisol in the sample. The fluorescent signal is measured using a compatible analyzer, allowing for quantitative detection of cortisol levels.

Technical dossier

Laboratory and clinical details

Materials provided
  • Main components (ref. IF1110, IF2110, IF3110, IF4110, IF5110):
  • 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)
  • - 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
  • - Store the kit at 4–30°C. It remains stable for 24 months from the date of manufacture, as indicated on the product label.
  • - Once the test cartridge pouch is opened, the cartridge must be used within 60 minutes to ensure accurate results.
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. Select the New Test mode, 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. For whole blood or capillary blood:
  7. Draw 30 μL of blood using the blood sampler and add it to the sample buffer tube.
  8. For serum or plasma:
  9. Draw 100 μL of serum or plasma using a transfer pipette and add it to the sample buffer tube.
  10. Step 3: Mix
  11. For whole blood or capillary blood:
  12. Mix the sample well with the buffer (dilution tube) by performing aspiration and dispensing movements with the blood sampler, repeating the process 6 to 8 times slowly and in a controlled manner.
  13. (That is, repeated pipetting to homogenize the mixture without shaking the tube.)
  14. For serum or plasma:
  15. Close the lid of the sample buffer tube and mix the sample well by shaking it about 6–8 times.
  16. Step 4: Loading
  17. Take 100 μL of sample mixture and load it into the test sample well.
  18. Step 5: Testing
  19. 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.
  20. 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 3 minutes 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
  • Assay Range and Detection Limit
  • - Assay Range: 11-1655 nmol/L
  • - Detection Limit: ≤ 11 nmol/L.
  • Precision
  • - Intra-Lot Precision (Within-Run): The coefficient of variation (C.V.) was ≤15%.
  • - Inter-Lot Precision (Between-Run): The coefficient of variation (C.V.) was ≤20%.
Precautions
- This kit is for in vitro diagnostic use only.
- Do not mix components from different kit lots.
- Do not use test kit beyond the expiration date.
- Tests should be applied by professionally trained staff working in certified laboratories at some remove from the patient and clinic at which the sample(s) is taken by qualified medical personnel.
- 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.
- The Test Cartridge and Meter should be used away from vibration and magnetic field. During normal usage, the Test Cartridge may introduce minute vibration, which should be regarded normal.
- 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.
- Do not smoke, eat, or drink in areas in which specimens or kit reagents are handled.
- 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.
- The results should be interpreted by the physician along with clinical findings and other laboratory test results.
- The test will be applied on a routine basis and not in emergency situations.
- Treat all specimens as potentially infectious.
- The foil pouch is non-biodegradable; handle and dispose of it in accordance with local environmental and biohazard regulations.
Limitations
- This test is designed for use with human serum, plasma, whole blood, and peripheral blood specimens only.
- The results of the Welleo Cortisol Assay should be interpreted in conjunction with all available clinical and laboratory data. If the Cortisol results do not align with the clinical evaluation, additional testing is recommended.
- False positive results may occur due to cross-reactivity with similar antibodies in the blood or due to non-specific components with similar epitopes binding to the fluorescent-labeled antibodies.
- False negative results may be caused by unknown substances that block epitope-binding antibodies, or by unstable or degraded Cortisol that cannot be detected due to improper sample handling, temperature fluctuations, or unsuitable storage conditions
- Other factors may interfere with the performance of the Welleo Cortisol Assay Kit, potentially leading to inaccurate results. These include technical or procedural errors and the presence of interfering substances in the blood specimen.

How to use the Welleo tests