Overview
Rapid self-test for detection of C-reactive protein (bacterial infection or inflammation) in blood.
The C-Reactive Protein (CRP) is a non-specific marker which is mainly produced by the liver and used to diagnose bacterial infectious disease and inflammatory disorders. The CRP is a very sensitive and fast appearing indicator which could therefore be helpful for deciding an antibiotic treatment. Depending on the CRP concentration, different lines will appear allowing the semi-quantitative interpretation of the test result.In healthy patients, CRP concentration is lower than 8mg/L while the concentration level can go higher than 100mg/L in case of severe infection or during inflammatory process. Intermediate levels, within 8 and 100mg/L, are concomitant with more or less mildly viral or bacterial infections that can be easily overcome byappropriate treatment ordered by your doctor.
Who is the test for?
CRP-Screen is for individuals seeking to distinguish the presence of a viral or bacterial infection.
How to use
- Prepare the test device, the pipette and the diluent dropper vial. Take them out from the protective pouch (tear at the notch. Remove the screw cap of the diluent dropper vial and leave it nearby.
- Clean the tip of the middle finger or ring finger with cotton wool moistened with alcohol. Press the lancet firmly against the side of the previously cleaned finger and press the release button.
- Without pressing the bulb, put in contact the plastic pipette with the blood sample. The whole blood migrates into the pipette through capillarity to the line indicated on the pipette. Place the collected whole blood sample into the opened diluent dropper vial by pressing the bulb of the pipette.
- Break the tip of the dropper bottle and slowly add exactly 4 drops in the sample well of the device with an interval of 2-3 seconds between each drop. Read the result after 5 minutes. Do not interpretafter 10 minutes.
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Results and recommendations
Analyze
Result
Summery
Test is negative
CRP level lower than 8 mg/L :Only two lines (no line under the mark T (Test)) appear. This result means that there is neither infection nor inflammation.
The test is positive
CRP level in the range of 8 to 40mg/L:
Three coloured lines appear in the windowbut the intensity of the line under T mark is weaker than the intensity of the two other lines. This result means that a viral infection could be on the way. You should consult your doctor.
The test is positive
CRP level in the range of 40 to 100mg/L: Three coloured lines appear in the window and the intensity of the 3 lines are more or less equal. This result means that a viral or bacterial infection is on the way. You must consult yourdoctor.
The test is positive
CRP level over 100mg/L:Three coloured lines appear in the windowbut the colour intensity of the lines under T and C marks are stronger than the colour intensity of the middle line. In case of very high CRP concentration, the middle line may even disappear. This result means that a severe bacterial infection is on theway. You must consult your doctor urgently.
Invalid result
Non valid result. If no line appears under the mark C (Control), it is not possible to interpret the test, which must be considered as non valid even a coloured line is visible under T (Test) mark and/or the middle line appears. In this case, it is recommended torepeat the test with a new CRP-Screen device
and a new blood sample.
Questions and answers
How does CRP-Screen® work?
If present in the sample, CRP will interact with the anti CRP antibodies as well as with the CRP antigen placed in the test producing different lines allowing a semi-quantitative measurement of the CRP concentration de in the blood sample (< 8 to > 100mg/L determined against W.H.O.* reference). A control line capturing the reagent excess appears as a coloured line under the C mark of the cassette.
*World Health Organisation.
When should the test be performed?
CRP-Screen® test should be performed in the case of acute infection symptoms such as
feverishness, fever, headaches or weakness. The test can be performed at any time of the day.
Can the result be incorrect?
The results are accurate as long as the instructions are carefully respected.
Nevertheless, the result can be incorrect if CRP-Screen® test gets wet before test performing or if the quantity of diluted blood dispensed in the sample well is not sufficient. The plastic pipette provided in the box allows making sure the collected blood volume is correct and is correctly diluted into the diluent dropper vial.
How to interpret the test if the colour and the intensity of the lines are different?
The colour intensity of the lines is important to interpret the test result. So please refer to the pictures and instructions in paragraph “Result interpretation”.
What is the line that appears under the mark C (Control) for?
When this line appears, it only means that the test has been performed well.
If I read the result after 10 minutes, will the result be reliable?
No. The result should be read within 10 minutes. The result is reliable up to 10 minutes but should be better read at 5 minutes after adding the sample.
What do I have to do if the result is positive?
If the result is positive when the CRP is higher than 8mg/L, please refer to the result interpretation and inform your doctor as soon as possible as an antibiotic treatment might be urgently needed.
What do I have to do if the result is negative?
If the result is negative when the CRP is lower than 8mg/L, it means that there is neither bacterial nor viral infection on the way. However, if the symptoms persist, it is recommended to consult your doctor.
What is the accuracy of CRP-Screen?
The CRP-Screenâ test is accurate and is used for more than 10 years by professionals in the field (hospitals, laboratories…). Evaluation reports show an overall agreement higher than 98.94% [93.85 – 100**] with reference methods. Although this test is reliable, false positive or false negative results can be obtained.
** CI 95%: 95% Confidence Interval