Rapid self-test for early detection of anti-Borrellia IgM antibodies from infected tick bites in blood (Lyme disease)

Ticks, insects found in undergrowth and temperate forests, can carry the Borrelia bacterium, which may be transmitted to humans (1 to 2% risk) through bites on unprotected areas like the arms or legs. Borrelia affects the nervous system, leading to serious neurological disorders. European Borrelia strains, including B. afzelli, B. garinii, B. burgdorferi sensu stricto, B. spielmanii, and B. bavariensis, are pathogenic, while B. valaisiana and B. lusitaniae are potentially pathogenic, causing cutaneous lesions and arthritis. Within 3 to 10 days after a tick bite, inflammation and erythema may occur, accompanied by fever. In case of infection, the immune system produces IgM antibodies, detectable 2 to 6 weeks post-infection. Lyme disease progresses in three phases: IgM antibodies appear in 40 to 60% during phase I (2 to 4 weeks), 70 to 90% during phase II (4 to 6 weeks), and are generally present in phase III. The TIK’ALERT® test can detect specific IgM antibodies, indicating recent Borrelia infection. Antibiotic therapy can treat infections, but the test cannot determine the illness stage with positive results.

Who is the test for?

For individuals to determine the presence or absence of IgM antibodies directed against the Borrelia bacterium in their bloodstream.

How to use

  1. 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).
  2. 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.
  3. 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.
  4. Dispense the blood into the sample well of the cassette, pressing down on the bulb of the pipette. Wait 30-40 seconds for blood absorption. Unscrew the blue cap from the dropper bottle, keeping the white cap secure. Add 4 drops of diluent to the well, spacing each drop 2-3 seconds apart. Read the result after 10 minutes. Do notinterpret after 15 minutes.

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Results and recommendations




  The test is positive
Two coloured lines appear in thewindow under the marks T Test) and C (Control). Theintensity of the line T may be clearer than the intensityof the line C. This result means that IgM antibodiesdirected against Borrelia bacterium are present inblood and an infection is starting. You must absolutelyconsult your doctor.
 Test is negative
Only one coloured line appearsunder the mark C (Control). Thisresult means that no antibodies directed againstBorrelia bacterium are detectable in blood.
 Invalid result
No line appears or a coloured lineappears under the mark T (Test) without any lineunder the mark C. In this case, it is not possible tointerpret the test, which must be considered as invalid.It is recommended to repeat the test with a newTIK’ALERT® device and a new blood sample

Questions and answers

How does TIK’ALERT® work?
In presence of Borrelia bacterium transmitted by a tick, specific IgMantibodies are produced first by the immune system. The antibodiescirculate in the blood and bind on the encountered bacteria. The Borreliaantigens coated on the TIK’ALERT® strip specifically detect those antibodiesby producing a coloured line under the T mark of the cassette.A control line capturing the reagent excess appears as a coloured lineunder the C mark of the cassette. In case both lines appear, the presence ofBorrelia bacterium can be suspected.
TIK’ALERT® test should be performed between 2 and 6 weeks after beingbitten by a tick or as soon as a round inflammation (erythema) appears on apart of the body likely which was exposed to a tick bite. It correspondsto the phase 1 of the disease for which the TIK’ALERT® is well suitable andfor which the test sensitivity is 53.8%. Contamination happens only in 1 to2% of the cases, but the presence of IgM antibodies, detected thanks to apositive result, indicates an infection that should be rapidly treated.
The results are accurate as long as the nstructions are carefully respected.Nevertheless, the result can be incorrect if TIK’ALERT® test gets wet beforetest performing or if the quantity of blood dispensed in the sample well isnot correct. The plastic pipette provided in the box makes sure the collectedblood volume is correct.
The colour and intensity of the lines have no importance for resultinterpretation. The lines should only be homogeneous and complete. Thetest should be considered as positive regardless of the colour intensity ofthe test line is (T) even weak.
When this line appears, it only means that the test has been performed well.
No. The result should be read within 10 minutes after adding the diluent.The result is reliable up to 15 minutes.
If the result is positive, it means that IgM antibodies directed againstBorrelia bacterium are detectable in blood and that you must absolutely consult a doctor showing him the test result. Then, the doctor will ordera treatment to follow in order to avoid complications arising after thisinfection. In case of past infection having occured several years before,a positive result can be obtained as the antibodies may be persisting insome persons. A positive result can also be obtained in patient having beenefficiently cured with antibiotics.
If the result is negative, it means that no IgM antibodies directed againstBorrelia bacterium are detectable in blood. Caution: Falsely negative resultscan be observed during phase I (antibodies appearing in 40 to 60% of thecases) or during phase II (antibodies rising in 70 to 90% of the cases) of thedisease development. In case of negative result, it is strongly recommendedto perform a new test 2 to 6 weeks later in order to check the increase ofantibodies level. If you have been preventively treated by antibiotics, theantibodies are not detectable or cannot be detected. If the tick’s bite istoo recent (less than 2 weeks), your organism has not had enough time toproduce detectable antibodies. It is recommended to repeat the test with anew TIK’ALERT® 2 to 6 weeks after the presumed bite. However, if a rash,accompanied or not by feverishness, persists, it is recommended to consultyour doctor.

The TIK’ALERT® test is accurate and is used by professionals in the field (hospitals, laboratories…). Evaluation reports show an overall agreement higher than 88.04% [81.88 – 92.5**] with reference methods. Despite the reliability of the test, falsely positive or false negative results are possible. This is especially true for patients being sero positive for cytomegalo-viruses (CMV) which may show false positive results when using the TIK’ALERT® test.

** CI 95%: 95% Confidence Interval