Description

Quick, accurate and easy-to-use self-test that can performed in the comfort of your own home.

Ticks are insects living in undergrowth and forests of temperate climatic zones. Those insects can be infected by a bacterium (Borrelia) that can be then transmitted to humans (1 to 2% transmission risk) after being bitten on the arm, the leg and any other part of the body not protected with clothes. Borrelia bacterium affects the nervous system and can lead to serious neurological disorders. European strains of Borrelia include B. afzelli, B. garinii, B. burgdoferi sensu stricto B. spielmanii, and B. bavariensis which are known pathogenic. Species B. valaisiana and B. lusitaniae are potentially pathogenic. That infection can also cause cutaneous lesions and arthritis. From 3 to 10 days, or even several weeks, after being bitten, an inflammation and redness (erythema) can appear in the bite region. The inflammation can be accompanied by feverishness.

In case of infection, the immune system reacts by releasing specific antibodies directed against Borrelia bacterium. A particular category of antibodies (IgM: immunoglobulins M) which appears first can be detected between 2 and 6 weeks after being infected. Lyme disease develops in 3 stages: In phase I (2 to 4 weeks), The IgM antibodies appear only in 40 to 60 % of the cases. During the phase II (4 to 6 weeks later), the antibodies are detectable in 70 to 90 % of the cases. At last during phase III, the antibodies are generally present and can be detected.

Using Check4® Tick Bite Borrelia test, it is possible to detect the presence of those specific IgM antibodies which appears first , and thus, a recent infection with Borrelia bacterium between 2 and 6 weeks after the presumed tick bite. Should the case arise, an antibiotic therapy will eliminate the infection.

Attention: However, this screening test cannot detect the stage of the illness in case of positive results.

The box contains the material necessary to perform a test:

  • 1 sealed aluminium pouch containing: 1 test device, 1 plastic pipette and 1 desiccant bag.
  • 1 sterile lancet for blood sampling.
  • 1 dropper bottle containing 1 ml of diluent.
  • 1 instruction leaflet.

All our Check4® range of self-test products are:

  • CE-Marked for home self-test use
  • Made and Evaluated in France
  • Easy-to-use and easy to read results
  • Accurate and trust worthy
  • Quick with results in a matter of minutes

Product Specification

Specification Type Specification Value
Product Range Self-Tests
Product Code 70084AG
Product Name Check4® Tick Bite Borrelia
Product Category Infection Health Tests
Product Analyte Anti-borrelia IgM antibodies
Product Size 1 x 1 Test
Product Storage 2°C to 30°C
How does the Check4® Tick Bite Borrelia test work?

In presence of Borrelia bacterium transmitted by a tick, specific IgM antibodies are produced first by the immune system. The antibodies circulate in the blood and bind on the encountered bacteria. The Borrelia antigens coated on the Check4® Tick Bite Borrelia test strip
specifically detect those antibodies by producing a coloured line under the T mark of the cassette. A control line capturing the reagent excess appears as a coloured line under the C mark of the cassette. In case both lines appear, the presence of Borrelia bacterium can be suspected.

When should the Check4® Tick Bite Borrelia test be used?

The Check4® Tick Bite Borrelia test should be performed between 2 and 6 weeks after being bitten by a tick or as soon as a round inflammation (erythema) appears on a part of the body likely which was exposed to a tick bite. It corresponds to the phase 1 of the disease for which the Check4® Tick Bite Borrelia test is well suitable and for which the test sensitivity is 53.8%. Contamination happens only in 1 to 2% of the cases, but the presence of IgM antibodies, detected thanks to a positive result, indicates an infection that should be rapidly treated.

Can the result be incorrect?

The results are accurate as far as the instructions are carefully respected. Nevertheless, the result can be incorrect if the Check4® Tick Bite Borrelia test gets wet before test performing or if the quantity of 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.

How do you interpret the test if the colour and the intensity of the lines are different?

The colour and intensity of the lines have no importance for result interpretation. The lines should only be homogeneous and clearly visible. The test should be considered as positive whatever the colour intensity of the test line is.

What is the line that appears under the mark C (Control) for?

When this line appears, it only means that the test was performing well.

If I read the result after 15 minutes, will the result be reliable?

No. The result should be read within 10 minutes after adding the diluent. The result is reliable up to 15 minutes.

What do I have to do if the result is positive?

If the result is positive, it means that IgM antibodies directed against Borrelia bacterium are detectable in blood and that you must absolutely consult a doctor showing him the test result. Then, the doctor will order a treatment to follow in order to avoid complications arising after this infection. In case of past infection having occurred several years before, a positive result can be obtained as the antibodies may be persisting in some persons. A positive result can also be obtained in patient having been efficiently cured with antibiotics.

What do I have to do if the result is negative?

If the result is negative, it means that no IgM antibodies directed against Borrelia bacterium are detectable in blood. Caution: Falsely negative results can be observed during phase I (antibodies appearing in 40 to 60% of the cases) or during phase II (antibodies rising in 70 to 90% of the cases) of the disease development. In case of negative result it is strongly recommended to perform a new test 2 to 6 weeks later in order to check the increase of antibodies level. If you have been preventively treated by antibiotics, the antibodies are not detectable or cannot be detected. If the tick’s bite is too recent (less than 2 weeks), your organism has not had enough time to produce detectable antibodies. It is recommended to repeat the test with a new Check4® Tick Bite Borrelia test 2 to 6 weeks after the presumed bite. However, if a rash, accompanied or not by feverishness, persists, it is recommended to consult your doctor.

How accurate is the Check4® Tick Bite Borrelia test?

The Check4® Tick Bite Borrelia test is accurate and is used by professionals in the field (hospitals, laboratories…). A study performed on a panel of 251 patients samples shows an overall result correlation of 88% when compared to reference methods. However it is still possible that the IgM antibodies appearing after an infection by Borrelia are not detected due to late maturation of the immune system of certain persons depending on the level of the disease. Despite the reliability of the test, falsely positive or falsely 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 Check4® Tick Bite Borrelia test.

Where can I find out more information or get further assistance on tick bites?

For more information on tick bites you can visit the below:

  • https://www.nhs.uk/conditions/lyme-disease/
  • https://www.gov.uk/government/publications/tick-bite-risks-and-prevention-of-lyme-disease