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Folic Acid Test

Check folic acid levels with quantitative accuracy.

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Only for Professional Use
The Welleo Folic Acid test quantitatively assesses folic acid levels to support evaluation of nutritional status. Digital analysis provides clear insight into folate levels.
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Technical product

Folic Acid Test

Description

Folic acid belongs to the class of phosphatidylglutamic acid (PGA) compounds and functions as a coenzyme in metabolic reactions involving the transfer of single carbon units from a donor to an acceptor molecule.

Both folic acid and vitamin B12 are essential for the synthesis of deoxyribonucleic acid (DNA) and are critical for the normal development and maturation of red blood cells. Folic acid is obtained through the daily diet, including foods such as fruits, green leafy vegetables, yeast, and organ meats. It is absorbed in the small intestine and stored in the liver.

Gastrointestinal disorders, pregnancy, and the use of certain medications—such as phenytoin—can lead to reduced folate intake or impaired absorption, resulting in folate deficiency. Chronic alcohol consumption is also associated with folic acid deficiency. Deficiencies in folic acid and vitamin B12 impair DNA synthesis and may lead to megaloblastic anemia.

Reference Interval

To determine the reference interval for this kit, serum or plasma samples were collected from 160 healthy women at hospitals and health examination centers. Based on the measurements, the reference interval established for this kit is: 5.2 – 20.0 ng/mL.

Intended use

The Folic Acid Assay Kit (Immunochromatographic Assay) is intended for the quantitative in vitro determination of folic acid in human serum, plasma, whole blood, and peripheral blood. This test utilizes a fluorescence immunoassay method. Folic acid levels in serum, plasma, or red blood cells are commonly measured to assess folate storage status. Serum folic acid serves as an indicator of recent dietary intake, while low folic acid levels in red blood cells may suggest a long-term deficiency. This product is for in vitro diagnostic use only and is intended for professional use.

Principle

The Folic Acid Assay Kit is based on fluorescence immunoassay technology and employs a sandwich immunodetection method. When a sample is added to the test's sample well, the fluorescence-labeled anti-folic acid detector antibody on the membrane binds to the folic acid antigen present in the blood specimen. As the sample mixture migrates along the nitrocellulose matrix of the test strip by capillary action, the formed complexes of the detector antibody and folic acid are captured by immobilized anti-folic acid antibodies on the strip. The amount of complex accumulated on the test strip is directly proportional to the concentration of folic acid in the specimen.

Technical dossier

Laboratory and clinical details

Materials provided
  • Main components (ref. SF430255, SF430256, SF430257):
  • 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 Folic Acid Assay Kit (Immunochromatographic Assay) at a temperature between 2°C and 30°C in its sealed pouch. The kit remains stable for up to 24 months under these conditions.
  • - If the kit is stored in a refrigerator, allow the test cartridge to reach room temperature for at least 30 minutes before use, while keeping it sealed in its pouch.
  • - Do not remove the test cartridge from its pouch until you are ready to perform the test. Once opened, the cartridge should be used within 60 minutes.
Test procedure
  1. Download the Welleo App from the Google Play Store or Apple App Store and sign in using your credentials. If you need to create an account, please contact your distributor. For detailed instructions on operating the instrument, follow the guidance provided on the reader screen.
  2. Step 1: Preparation
  3. Ensure both the test cartridge and the blood sample are at room temperature before starting. Open the foil pouch, remove the test cartridge, and place it on a flat surface. Press the “+” button in the app to start a new test. Scan the QR code on the test cartridge and follow the on-screen instructions. Enter the Patient ID, Sample ID, and select the sample type if applicable.
  4. Step 2: Sampling
  5. Using a transfer pipette, draw 20 μL of serum, plasma, whole blood, or peripheral blood and add it to the buffer tube.
  6. Step 3: Mixing
  7. Mix the specimen thoroughly with the buffer and allow it to react at room temperature for 1 minute.
  8. Step 4: Loading
  9. Take 80 μL (approximately 3 drops) of the mixed sample and dispense it vertically into the sample well of the test cartridge. Start the timer immediately.
  10. Step 5: Testing
  11. Press the Start Timer button in the app and wait for the 15-minute reaction period. A countdown timer will be displayed on the screen.
  12. Before the timer expires, connect the Welleo Reader to the mobile app. Insert the test cartridge into the reader. Once inserted, the app animation will change, prompting you to extract the cartridge at a constant speed.
  13. After a few seconds, the test result will be displayed. If prompted to repeat the reading, follow the instructions provided.
  14. Important: If the test is not processed within 3 minutes after the countdown ends, the result will be considered invalid and a new test must be performed.
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
  • Limit of Blank
  • The lowest concentration distinguishable from zero is ≤ 1.0 ng/mL.
  • Accuracy
  • The assay provides results within ±15.0% of the true value.
  • Linearity
  • The test shows linear performance across the concentration range of 1.0 ng/mL to 20.0 ng/mL, with a correlation coefficient (R) of ≥ 0.99.
  • Repeatability
  • The coefficient of variation (CV) for repeated measurements is ≤ 15.0%.
  • Batch Consistency
  • The variation between different production batches is ≤ 15.0% CV.
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.
- This product 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 should be used away from vibration and magnetic field.
- Do not smoke, eat, or drink in areas in which specimens or kit reagents are handled.
- Blood specimens, used test cartridges, blood collectors 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 kit is intended solely for the detection of folic acid in human serum, plasma, and whole blood samples.
- The results obtained from the Folic Acid Assay Kit (Immunochromatographic Assay) should be interpreted in conjunction with all available clinical and laboratory data. If the test results do not align with the clinical evaluation, additional diagnostic tests should be considered.
- The presence of interfering substances in the sample may affect the accuracy of the results. The assay has been validated to tolerate certain concentrations of common interferents, including hemoglobin up to 5 g/L, triglycerides up to 5 g/L, and bilirubin up to 0.2 g/L. Samples exceeding these levels may produce unreliable results.

How to use the Welleo tests