Lyme Disease Screening Test

Tik'Alert Self-Testing Kit

The Tik'Alert self-testing kit is a simple, 10 minute, finger-prick blood test which screens for immunoglobulin M (IgM) anti-Borrelia burgdorferi antibodies.

Lyme disease, tick bites and Borrelia bacteria

Lyme disease is caused by an infection with Borrelia bacteria which is spread to humans by tick bites.

Ticks are tiny spider-like creatures often found in UK woodlands, parks and gardens. It can take the body two to four weeks to produce detectable levels of IgM antibodies after a tick bite, reaching a maximum at about six weeks and then begin to decline. According to the UK's Health Security Agency, ticks can be active all year round, but they are most active in the months April to July, and sometimes later in the autumn. Not all ticks harbour Borrelia bacteria.

Symptoms of Lyme disease

Reliable information on the signs and symptoms of Lyme disease can be found on the NHS website. In some people, early symptoms may include a circular or oval shape rash around a tick bite. The rash usually appears within 1 to 4 weeks, but can appear up to 3 months after being bitten by an infected tick, and can last for several weeks. Some people also get flu-like symptoms a few days or weeks after an infected tick bite.

More severe symptoms, months or years after being infected, may occur in some people if treatment for Lyme disease is delayed.

Whether you have a positive or negative Tik'Alert test result, you must ask for an urgent GP appointment If you have symptoms of Lyme disease and think you may have been bitten by a tick.

How Borrelia specific IgM antibodies are detected

The Tik'Alert technology is similar to that of a 'Western blot' used in serology laboratories, where Borrelia antigens (proteins) are bound to a nitrocellulose membrane. Blood is then added to the membrane and allowed to react with the bound proteins. If anti-Borrelia IgM antibodies are present in the blood sample, they will also bind to the Borrelia antigens immobilised on the nitrocellulose membrane. The next step is to add detector antibodies that bind specifically to human IgM antibodies - in our case, the detector antibodies are conjugated to gold nanoparticles which are red in colour.

The Tik'Alert chemistry takes just 10 minutes to give a result - a positive result is indicated by a pink or red coloured line next to both T and C symbols on the lateral flow test cassette.

Tik'Alert Test Procedure

Each Tik'Alert test kit contains instructions and follow-up information in clear English. The procedure is safe and simple but it is important to read and understand the instructions before starting the test. In summary:

1. Collect a few drops of blood from your finger tip using the sterile lancet and soft plastic pipette provided
2. Add the blood to the Tik'Alert lateral flow test device
3. Add the diluent drops and wait 10 minutes to read your result

Tik'Alert accuracy and limitations

The accuracy of serological IgM tests depends on when the test is used, as the level of IgM antibodies can take a few weeks or more to develop to detectable levels and some people may not produce detectable levels of anti-Borrelia IgM antibodies. Full information is provided with the Tik'Alert test kit.

• Sensitivity 89.09%
• Specifcity 89.29%
• Overall agreement 89.19%

These figures represent the accuracy of the VedaLab Tik'Alert self-test device for detecting anti-Borrelia IgM antibodies compared to a laboratory reference method (ELISA/ Diasorin/VIDAS), and not the accuracy of the test for diagnosing Lyme disease, which is dependent on other factors such as how long after the tick bite the test was used. Read more about the limitations of IgM antibody screening for Lyme disease diagnosis.

UK certification and regulation

All self-test devices must be properly certified and registered in the UK. The Tik'Alert Lyme disease screening self-test kit is CE certified for self-testing according to the In-Vitro Diagnostics Directive (IVDD) which are the regulatory requirements for use in the UK, and registered with the MHRA. Manufactured in France by VedaLab.

Tik'Alert Test contents

• 1 x Instruction leaflet
• 1 x Test cassette
• 1 x Blood spot collection tube
• 1 x Dropper bottle
• 1 x Finger pricker

UK customer support

If you have any questions regarding how the test works or need help to use your test, technical support is provided by our team of immunodiagnostics experts. However, we do not provide medical advice.

Further reading on Lyme disease

Lyme disease IgM tests - LabTestsOnline UK

Lyme disease NICE guideline Reference number: NG95

Lyme Disease UK

NHS Lyme Disease

What is Lyme disease and why do we need to be tick-aware? UK Health Security Agency

Self-testing kits are intended for preliminary screening only. Whether your result is positive or negative, always speak with your pharmacist or doctor if you are anxious about your health or concerned about your symptoms.