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Ferritin Test

Quantify ferritin levels to assess iron stores.

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Only for Professional Use
The Welleo Ferritin test measures ferritin levels in blood samples to evaluate iron storage in the body. Fluorescence immunoassay technology delivers objective and reliable results.
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Technical product

Ferritin Test

Description

Ferritin is a large molecular weight iron-containing protein, molecular weight of about 450000, a ferritin molecule can bind 4000 to 5000 iron atoms, ferritin is the main iron storage protein in the body. The concentration of ferritin is proportional to the total iron content in the body, making serum ferritin levels a common diagnostic tool for assessing iron status. Decreased serum ferritin concentration is common in iron deficiency anemia, occult iron deficiency anemia; Serum ferritin increased in patients with hemolytic anemia, and serum ferritin increased significantly in patients with megaloblastic anemia, aplastic anemia and acute hematopoietic arrest. The determination of ferritin in pregnant women can be used as an effective indicator for the prevention and treatment of iron deficiency and anemia during pregnancy.

The reference interval of the kit was determined by statistical analysis of the determination results of healthy people:

Gender | Reference Interval (ng/mL) | Male | 16.0-220.0 | Female | 10.0-125.0

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

Intended use

This product is intended for the quantitative determination of ferritin content in human serum, plasma, whole blood and peripheral blood samples in vitro, and is mainly used clinically for the auxiliary diagnosis of iron metabolism-related diseases. For in vitro diagnostic use for professional users.

Principle

The Ferritin Assay Kit is based on fluorescence immunodetection technology. The Ferritin Assay Kit uses the fluorescent immuno-double antibody sandwich method to determine the concentration of ferritin in a sample. The sample was added to the sample dilution and mixed and then added dropwise to the test card sampling well, and the ferritin in the sample and the fluorescent microspheres in the fluorescent pad labeled ferritin monoclonal antibody 2 combined to form an antigen-antibody complex, which spread forward along the nitrocellulose membrane under capillary action, and the complex was captured by ferritin monoclonal antibody 1 fixed on the nitrocellulose membrane detection line. Excess fluorescent microsphere-labeled ferritin monoclonal antibody 2 was captured by sheep anti-murine IgG immobilized on the nitrocellulose membrane quality control line, and the more ferritin in the sample, the more complexes accumulated on the detection line, and the intensity of the fluorescent antibody signal was positively correlated with the ferritin concentration in the sample.

Technical dossier

Laboratory and clinical details

Materials provided
  • Main components (ref. SF290255, SF290256, SF290257):
  • 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 detector buffer at 2~30℃. The buffer is stable up to 24 months.
  • - Store test kit at 2~30℃, shelf life is up to 24 months.
  • - Test Cartridge should be used within 60 minutes after opening the pack.
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. Draw 10 μL of whole blood with a transfer pipette and add it to the 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. Mix well the specimen with buffer for 10 seconds by tapping or inverting the tube.
  9. Step 4: Loading
  10. Take 75 μL of sample mixture and load it onto the sample well of the Test Cartridge. If using the whole blood sampler, place 3 drops in the sample well.
  11. Step 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 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
  • Blank detection limit
  • The blank detection limit ≤0.5 ng/mL
  • Accuracy
  • The relative deviation (Bias) is within ±15.0%.
  • Linear range
  • The linear range of determination is between 6.0ng/mL, 1000.0ng/mL, and the linear correlation coefficient (R) is ≥ 0.99.
  • Repeatability
  • The coefficient of variation within batch≤ 15.0%.
  • The coefficient of variation between batches ≤ 15.0%.
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.
- The tests should be applied by professionally trained and certified staff working in certified centers.
- 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.
Limitations
- This test has been developed for testing human serum, plasma specimen only.
- The results of the Assay Kit should be evaluated with all clinical and laboratory data available. If Ferritin test results do not agree with the clinical evaluation, additional tests should be performed.
- The false positive results may come from cross-reactions with some similar antibodies in blood; and similar epitopes from non-specific components in blood capturing fluorescent labeled antibodies.
- The false negative results may from some unknown substance blocking epitope adhering antibodies, unstable or degenerated Ferritin that cannot be identified due to prolonged time and temperature and storage condition of sample and reagent. .
- Other factors may interfere with the Assay Kit and may cause erroneous results. These include technical or procedural errors, as well as additional substances in blood specimens.

How to use the Welleo tests