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CRP Test

Quantitative CRP testing to assess inflammation levels.

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Only for Professional Use
The Welleo CRP test provides quantitative measurement of C‑reactive protein, a key inflammation marker. Used with the Welleo Reader, it delivers fast and objective data to support inflammatory status evaluation.
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Technical product

CRP Test

Description

C-reactive protein (CRP) is synthesized by the liver in response to interleukin-6 and well known as one of the classical acute-phase reactants and as a marker of inflammation. The serum CRP level may rise from a normal level of <5 mg/L to 500 mg/L during the body’s general, non-specific response to infectious and other acute inflammatory events. high-sensitivity CRP (hs-CRP) is also emerging as the strongest and most independent predictive risk factor for atherosclerosis and cardiovascular diseases(CVD).

For people the diagnosis of inflammatory disease and CVD assessment cutoffs have been recommended as follows:

Concentrations | Clinical reference | < 1.00 mg/L | Low CVD risk (No Inflammation Situation) | 1.00~3.00 mg/L | Moderate CVD risk (No Inflammation Situation) | > 3.00 mg/ | High CVD risk (No Inflammation Situation) | > 10.00 mg/L | There may be other infections (bacterial infections or viral infections) | 10.00~20.00 mg/L | Generally indicates viral infections or mild bacterial infection | 20.00~50.00 mg/L | Generally indicates moderate bacterial infection | > 50 mg/L | Generally indicates serious bacterial infection

Intended use

The Welleo CRP Rapid Test Kit is intended for the in vitro quantitative determination of CRP in human serum, plasma, and whole blood. It is a fluorescence immunoassay for the diagnosis infection and inflammation and predict future cardiovascular diseases (CVD). For in vitro diagnostic professional use only.

Principle

The Welleo CRP Rapid Test Kit is based on fluorescence immunoassay technology. The Welleo CRP Rapid Test Kit uses a sandwich immunodetection method, when sample is added to the sample well of the Test Cartridge, the fluorescence- labeled detector CRP antibody binds to CRP antigen in blood specimen. As the sample mixture migrates on the nitrocellulose matrix of test strip by capillary action, the complexes of detector antibody and CRP are captured to CRP antibody that has been immobilized on test strip. Thus the more CRP antigen is in blood specimen, the more complexes are accumulated on test strip. Signal intensity of fluorescence of detector antibody reflects amount of CRP captured and Welleo Lateral Flow Reader shows CRP concentration in specimen. The default results unit of Welleo CRP Rapid Test Kit is displayed as XXX mg/L from the reader. The working range and the detection limit of the CRP Test system are 0.50~200.00 mg/L and 0.50 mg/L.

Technical dossier

Laboratory and clinical details

Materials provided
  • Main components (ref. SF010255, SF010256, SF010257):
  • 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 set (10 μL, 100 μL size)
  • - Sample Collection Containers
  • - Centrifuge (for Plasma/serum only)
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. Store the product at 2-30℃ in its sealed pouch up to 24 months.
  • 2. 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 on “+” 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 8.5 μL of whole blood or 5 μL of serum/plasma 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 1 minute 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 2 drops in the sample well.
  11. Step 5: Testing
  12. Press Start Timer button and wait for the 3 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
  • Accuracy
  • A comparison study has been performed using 153 human blood samples, CRP concentrations ranging from 0.54 mg/L to 122.20 mg/L， demonstrated good correlation with a commercially available kit.
  • Comparison between this test kit and the FinecareTM CRP (C-reactive protein) Rapid Quantitative Test was conducted for 153 clinical samples, the Correlation Coefficient is 0.98.
  • Assay range and Detection Limit
  • - Assay Range: 0.50~200.00 mg/L
  • - Detection Limit: 0.50 mg/L
  • Linearity
  • A serial concentration of CRP controls of 0.50mg/L, 5.00mg/L, 10.00mg/L, 20.00mg/L, 50.00mg/L, 100.00mg/L were each tested for three times, the Correlation Coefficient (R) is≥0.9900.
  • Precision
  • Intra-Run
  • Within-run precision has been determined by using 10 replicates of four specimens containing 3.00 mg/L and 10.00 mg/L CRP. C.V. is ≤20%.
  • Inter-Run
  • Between-run precision has been determined by using 10 replicates for each of three lots using CRP specimen levels at 3.00 mg/L and 10.00 mg/L. C.V. is≤20%.
Precautions
1. This kit is for in vitro diagnostic use only.

2. Do not mix components from different kit lots.

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

4. 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.

5. The test cartridge should remain in its original sealed pouch until ready to use.

6. Do not use the test cartridge if the pouch is punctured or not well sealed,

7. 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.

8. 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.

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.
Limitations
1. This test has been developed for testing whole blood, human serum and plasma specimen only.

2. The results should be evaluated with all clinical and laboratory data available. If hs-CRP test results do not agree with the clinical evaluation, additional tests should be performed.

3. 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.

4. EDTA other than anticoagulants (e.g. heparin or citrate) is suggested to use for plasma.

5. Other factors may interfere with the product 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