SELFCHECK Stomach Ulcer Test - Data Sheet for HCPs
PRODUCT: SELFCHECK Stomach Ulcer (H. pylori) TEST
PRODUCT CODE: SCSUT1
REVISION DATE: 15th August 2025
Test Principle and Specifications
Intended use
The SELFCHECK Stomach Ulcer Test is a manual, qualitative, solid-phase immunochromatographic (lateral flow) immunoassay for the detection of human anti-Helicobacter pylori antibodies (H. pylori) in a finger-prick whole blood sample.
Clinical Context and Limitations
This is a screening test and is not intended for diagnosing a stomach ulcer. A single test result should not be the sole basis for a clinical decision.
The presence of H. pylori bacteria in the lining of the stomach or intestine can cause chronic gastritis that can lead to a stomach ulcer. During an infection with H. pylori, the immune system may produce antibodies that are detected in the blood. Positive results may also be detected in patients who have been successfuly treated for a H. pylori infection.
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-H. pylori antibodies
Methodology
Immunochromatographic (lateral flow) assay
Sample type
Finger-prick whole blood sample
International standard
N/A
Cut-off level
15 AU/mL
Performance vs. laboratory reference method (VIDAS/ ELISA DSX/ ENZYGNOST)
Sensitivity: 92.54%
Specificity: 96.0%
Overall agreement: 93.48% (95% confidence interval of 85.74 - 97.72%)
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