SELFCHECK Lyme Disease Test - Data Sheet for HCPs
PRODUCT: SELFCHECK LYME DISEASE TEST
PRODUCT CODE: SCLYM1
REVISION DATE: 15th August 2025
Test Principle and Specifications
Intended use
The SELFCHECK Lyme Disease Test is a manual, qualitative, solid-phase immunochromatographic (lateral flow) immunoassay for the detection of anti-Borrelia IgM antibodies in a finger-prick whole blood sample. The test is intended for home use by lay individuals for self-testing, specifically to identify potential IgM antibodies to Borrelia bacteria following a recent tick bite.
Clinical Context and Limitations
This is a screening test and is not intended for diagnosing Lyme disease. A single test result should not be the sole basis for a clinical decision. A clinical evaluation by a healthcare professional is required to interpret results fully in the context of the patient's overall health and symptoms.
Upon Borrelia infection, the host's immune system elicits a response characterised by the production of specific antibodies. 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.
It is recommended that this test be carried out between two and six weeks following a tick bite, or after the appearance of a circular rash (erythema migrans) in an area where a tick bite is suspected. This timeframe represents Phase 1 of the illness, for which the test demonstrates a sensitivity of 53.8%.The presence of detectable IgM antibodies, shown by a positive result, suggests an infection for which prompt treatment is necessary.
A negative result indicates that IgM antibodies to Borrelia bacteria were not detected at the time of testing. However, false negative results can occur during Phase 1 when antibodies are present in 40 to 60% of cases, or Phase 2 when antibodies are present in 70 to 90% of cases of Lyme disease development.
This screening test does not determine the stage of illness in the event of a positive result.
All medical tests, whether used in a hospital laboratory or at home, have limitations and carry a possibility of false positive or false negative results due to individual physiological variations and interpretation of the instructions for use (IFU). This test should be used as one part of a broader approach to health management, including healthcare professionals.
Performance Characteristics
Biomarker
Human anti-Borrelia IgM antibodies
Methodology
Immunochromatographic (lateral flow) assay
Sample type
Finger-prick whole blood sample
International standard
N/A
Cut-off level
N/A
Performance vs. laboratory reference method (ELISA/ DIASORIN/VIDAS)
Sensitivity: 89.09%
Specificity: 89.29%
Overall agreement: 89.19% (95% confidence interval of (81.14 - 94.46%)
Regulatory and Quality Assurance
Device Classification
In Vitro Diagnostic (IVD) medical device for self-testing, and compliant with the UK Medical Devices Regulations 2002 (as amended).
Conformity Mark
CE marked for self-test use according to the EU In Vitro Diagnostic Directive 98/79 EC (IVDD), including the four-digit number (0483) of the responsible Notified Body. This number is a critical indicator that the device has undergone third-party review specifically for self-test use, distinguishing it from professional-use-only devices used in hospital laboratories and health care professionals. Notified and Approved Bodies are independent, third-party organisations designated by the Competent Authority (MHRA in the UK) to assess the conformity of IVDs to relevant regulations and standards including the IVDD and the In Vitro Diagnostic Regulations.
Regulatory Authority
Registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Quality Management System
Components are assembled in the United Kingdom by J R Biomedical Ltd., at an ISO 13485:2016 certified medical device manufacturing facility, independently audited by UKAS accredited auditors, for the design, development, and manufacture of in-vitro diagnostics. J R Biomedical Ltd (est. 2005), is a developer and supplier of diagnostics to the NHS and medical research laboratories.
Legal Manufacturer
VEDALAB, Rue de l'Expansion, Alençon, France.
UK Distributor
1st Health Products Ltd.
Further information
J R Biomedical Ltd. OpTIC Technology Centre, Wrexham University, St Asaph Business Park, St Asaph, LL17 0JD. United Kingdom.
Telephone 01745 535 169