Lyme Disease Test | Borrelia IgM Antibody Home Blood Test

Intended use The SELFCHECK Lyme Disease Test is registered with MHRA as a CE certified, in-vitro diagnostic medical device for self-testing. Finger-prick blood test Safe and easy to use Results at home in minutes CE certified for self-test use Contains 1 test. The test is a manual, qualitative, immunochromatographic (lateral flow), self-test for the immunological detection of anti-Borrelia immunoglobulin M (IgM) antibodies in a finger prick whole blood sample. The test is intended for home use by the general public to detect IgM antibodies to Borrelia bacteria following a recent tick bite. General information Lyme disease is an infection caused by Borrelia bacteria, which are 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 antibodies after a bite. IgM antibodies are produced first, which increase to a maximum level after about six weeks, but then begin to decline. Once transmitted, Borrelia bacteria can affect the nervous system, potentially leading to severe neurological disorders. An infection can manifest as skin lesions and arthritis. A characteristic redness of the skin, accompanied by inflammation, may appear at the bite site within three to ten days, or even several weeks post-bite, and may be accompanied by fever. Upon Borrelia infection, the immune system elicits a response characterised by the production of specific antibodies in the blood stream. Immunoglobulin M (IgM), the initial antibody isotype to appear, is detectable within a two to six week post-infection window. Lyme disease exhibits a triphasic progression. During the initial phase (two to four weeks), IgM antibodies are demonstrable in 40 to 60% of affected individuals. In the subsequent phase (four to six weeks post-initial phase), antibody detection rates increase to 70 to 90%. In the final phase, antibodies are typically present and readily detectable. If diagnosis and treatment is delayed, some people may develop more severe symptoms months or years after being infected. Time to result The test gives a result in 10 minutes at home. Warnings A test for a single biomarker, such as IgM anti-Borrelia antibodies, is not a diagnosis. Do not change your medication, diet or lifestyle solely on the basis of a self-test - always discuss your result with an appropriate healthcare professional first. Not following the instructions exactly as written in the instructions for use may cause a false positive or false negative result. In the event of a positive result, this test does not determine the stage of illness. IgM antibody tests for Borrelia, whether performed at home with a self-testing kit, or by a hospital laboratory, have significant limitations due to frequent false positive results, including individuals who are sero-positive for cytomegalo-viruses (CMV), Epstein Barr virus, (EBV), herpes simplex virus (HSV), syphilis, leptospirosis, mononucleosis or autoimmune disorders. A self-test result for anti-Borrelia IgM antibodies by itself should be viewed with caution until it is followed up by a consultation with a doctor. Whether you have a positive or negative self-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. Accuracy The test has an overall agreement of 89.19% (81.14-94.46)*, sensitivity of 89.09%, and specificity of 89.29% with laboratory tests for anti-Borrelia IgM antibodies. Although this test is reliable for the detection of anti-Borrelia IgM antibodies, all medical tests can give false positive or false negative results. IMPORTANT: These figures refer to the agreement of the SELFCHECK test with laboratory anti-Borrelia IgM antibody tests, and not to the accuracy of tests for the diagnosis of Lyme disease. *95% confidence interval. Further information Information on Lyme disease, Borrelia infection and related diseases: www.nhs.uk/conditions/lyme-disease www.nice.org.uk/guidance/ng95 Information for health care professionals Principle, performance data, and regulatory information on the SELFCHECK Lyme Disease Test for health care professionals. Updated 14th April 2026