SELFCHECK Urine Pregnancy Test - Data Sheet for HCPs
PRODUCT: SELFCHECK URINE PREGNANCY (hCG) TEST
PRODUCT CODE: SCPUT2
REVISION DATE: 15th August 2025
Test Principle and Specifications
Intended use
The SELFCHECK Urine Pregnancy Test is a manual, qualitative, solid-phase immunochromatographic (lateral flow) immunoassay for the detection of raised levels of human Chorionic Gonadotrphin (hCG) in a mid-stream urine sample.
Clinical Context and Limitations
Each pack contains two mid-stream urine device for the detection of pregnancy. The test can be used from the day of the first missed period. For maximum sensitivity, a urine sample from first thing in the morning should be used.
A high fluid intake can dilute the level of hCG in the urine increasing the chances of a false negative result during early pregnancy. A second device is included with the test kit to confirm the result two to three days later.
The test may show a false positive result if the patient is on medication containing hCG, or drugs used in combination with hCG, for example; Pregnyl, Porfasi or Pergonal. A false positive result may occur if the patient has had a miscarriage, abortion or has given birth within the past 8 weeks, due to residual, but detectable hCG in the blood.
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 Chorionic Gonadotrophin (hCG)
Methodology
Immunochromatographic (lateral flow) assay
Sample type
Mid-stream urine
International standard
WHO 99/688
Cut-off level
25mIU/mL
Performance vs. laboratory reference method (Chiron)
Sensitivity: 100%
Specificity: 98.33%
Overall agreement: 99%
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