SELFCHECK Faecal Immunochemical Test (FIT) - Data Sheet for HCPs
PRODUCT: SELFCHECK FAECAL IMMUNOCHEMICAL TEST
PRODUCT CODE: SCFIT1
REVISION DATE: 15th August 2025
Test Principle and Specifications
Intended use
The SELFCHECK Faecal Immunochemical Test (FIT) is a manual, qualitative, solid-phase immunochromatographic (lateral flow) immunoassay for the detection of occult (hidden) blood in a stool sample. It is designed specifically for use at home by members of the public for the detection of colorectal abnormal bleeding disorders.
Clinical Context and Limitations
This is a screening test and although FIT is used in bowel cancer screening programs, this test is not intended for diagnosing bowel cancer. 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.
Although faecal immunochemical tests are used for bowel cancer screening, blood may be present in faeces for other reasons such as ulcers, colitis or haemorrhoids. Colon polyps are known to bleed intermittently, and testing samples from three different days increases the probability of detecting blood compared to sampling on just one occasion.
This test uses a pair of antibodies that specifically detect human haemoglobin, producing a coloured line next to the letter T on the test cassette. A control line next to the letter C on the test cassette captures excess reagents. As with other faecal immunochemical tests, there is a risk of false positive results if the stool sample is contaminated with blood from another area such as cuts, haemorrhoids, or menstruation.
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 haemoglobin
Methodology
Immunochromatographic (lateral flow) assay
Sample type
Stool sample
Calibration material
Purified haemoglobin
Cut-off level
40 µg Hb/g faeces
Performance vs. laboratory reference method (HEMOCCULT II/ HEMOFEC / HEMOLEX)
Sensitivity: 90%
Specificity: 100%
Overall agreement: 93% (95% confidence interval of (86.78 - 97.17%)
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