Prostate Health Test (PSA Test)

Intended use The SELFCHECK Prostate Health Test (PSA Test) is registered with MHRA as a CE certified, in-vitro diagnostic medical device for self-testing. Finger-prick blood test Safe and easy to use Results at home in minutes CE certified for self-test use Contains 1 test. The test is a manual, qualitative, immunochromatographic (lateral flow), screening self-test for the immunological detection of prostate specific antigen (PSA) in a finger prick whole blood sample. In the UK, men over 50, those with a family history of prostate cancer, or are of black ethnic origin can ask their NHS GP for a PSA test, even if they do not have symptoms. General information PSA is produced by the prostate gland, which is situated in the abdomen under the bladder, and plays an important role in the production of semen. There are many reasons other than prostate cancer that can cause elevated levels of PSA in the blood. Time to result The test gives a result in 10 minutes at home. Warnings A screening test for a single biomarker, such as PSA, is not a diagnosis. Not following the instructions exactly as written in the instructions for use may cause a false positive or false negative result. Do not change your medication, diet or lifestyle solely on the basis of a self-test - always discuss your result with an appropriate healthcare professional first. A screening test for PSA by itself will not rule in, or rule out prostate cancer, or any other specific prostate disorder. The level of PSA in the blood is a general marker of prostate physiological status, and can be raised for many reasons other than prostate cancer. Conversely, only some people with prostate cancer will have higher than normal PSA levels. A positive PSA result can cause anxiety and lead to further tests which may show no serious problem, and a negative test result could give a false sense of security. Consider the potential emotional impact of your result before deciding to test. Whether you have a positive or negative PSA result, always speak with your doctor if you have symptoms or are at an increased risk of prostate cancer. This test is not intended for monitoring PSA levels in patients who have been diagnosed with prostate cancer. Accuracy The SELFCHECK PSA test has a cut-off of 4 ng/mL of PSA calibrated against the WHO 17/100 international standard, and an overall agreement of 97% (91.06-99.61)*, sensitivity of 98.28%, and specificity of 95.24% with laboratory tests for PSA. Although this test is reliable for the detection of PSA, all medical tests can give false positive or false negative results. IMPORTANT: These figures refer to the agreement of the SELFCHECK test with laboratory PSA tests, and not to the accuracy of tests for the diagnosis of prostate cancer. *95% confidence interval. Further information UK Government Guidance on PSA testing NHS - PSA Test Information for health care professionals Principle, performance data, and regulatory information on the SELFCHECK Prostate Health Test for health care professionals. Revision 14th April 2026.