SELFCHECK Gluten Sensitivity Test - Data Sheet for HCPs
PRODUCT: SELFCHECK GLUTEN SENSITIVITY (COELIAC DISEASE) TEST
PRODUCT CODE: SCGLU1
REVISION DATE: 15th August 2025
Test Principle and Specifications
Intended use
The SELFCHECK Gluten Sensitivity Test is a manual, qualitative, solid-phase immunochromatographic (lateral flow) immunoassay for the detection of human anti-tissue transglutaminase IgA antibodies (t-TG IgA) in a finger-prick whole blood sample.
Clinical Context and Limitations
This is a screening test and is not intended for diagnosing coeliac disease. A single test result should not be the sole basis for a clinical decision.
The test is not intended for patients who are on a strict gluten free diet, actively avoiding food and drink products containing wheat, rye or barley. The test is unsuitable for children under 2 years old. As this test is specific for IgA antibodies, a false negative result may be caused by IgA deficiency.
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
Anti-tissue transglutaminase IgA antibodies (t-TG IgA)
Methodology
Immunochromatographic (lateral flow) assay
Sample type
Finger-prick whole blood sample
International standard
N/A
Cut-off level
10 U/mL
Performance vs. laboratory reference method (ImmunoCAP Phadia)
Sensitivity: 97.2%
Specificity: 96.0%
Overall agreement: 96.7% (95% confidence interval of 90.79 - 99.60%)
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