A series of BBC reports have gone live today detailing concerns over PSA home testing kits. At GFCT, we have been conducting PSA tests for over 20 years, which have led to over 3,200 cancer diagnoses that otherwise may not have been discovered. PSA testing does not directly detect prostate cancer, but is an important indicator for determining your risk level. As well as our testing events, we offer home kits. Please note that our PSA home testing kits are NOT the same as the PSA lateral flows that are being rightfully questioned on the BBC today. Our founder, Graham Fulford, was featured on BBC Hereford & Worcester this morning (5th March) interviewed by Tammy Gooding, to explain the difference and give his insight.
What’s the difference?
With a PSA lateral flow home testing kit as referenced in BBC reports, a blood sample is taken at home, dropped onto a testing strip and a positive or negative (high or low) result appears within minutes. The home kits that we offer involve a self-collection of blood, but this sample is then posted to our laboratory partner for analysis, and a more detailed result is obtained - a PSA score that is signed off by a doctor.
Our stance on home testing kits:
We would like to make it clear that we only support fully accredited laboratory testing and in this respect are proud to announce that since launching our self-collection testing at home service during the Covid crisis in June 2020, we've carried out 25,663 tests to date without a single complaint concerning their accuracy. This has led to 1228 Red finds and 789 Amber finds, leading to the early detection of a number of prostate cancers that might otherwise have not been found. We offer these home testing kits for people who may not be able to get to a testing event for a blood sample due to factors such as disability or area of residence.
Where do our results come from?
All blood tests offered by GFCT are processed by TDL. The Doctors Laboratory (TDL) provides comprehensive cancer diagnostics with advanced technology and expert analysis. With over 30 years of experience, TDL is UKAS-accredited, ensuring high-quality, precise, and timely results, making it a trusted partner in healthcare. TDL also carries out all Stockholm3 (advanced PSA test) results. Please see this response from our laboratory partner following concerns about the accuracy of some lateral home testing kits:
“It is important to clarify whether the concern relates to Self Collection or Self Testing.
Self Collection (GFCT Tests)
Self-Collection sampling allows for the collection of a blood sample at home. Self-Collection allows for testing of the blood sample that has been collected at home to be processed in an ISO 15189 accredited clinical laboratory. The sample required is a collection of blood drops using a kit made up of components that are verified for the specific intended use of PSA testing. The kit and its contents must be registered to the accredited PSA test performed in the laboratory. The collected blood sample needs to be sent to the an ISO 15189 accredited laboratory by Royal Mail, or some other form of safe delivery arrangement, for testing. This addresses the need for clinically approved stability and comparative performance. To do this, the kit that is provided for self-collection of blood drops must be made up and comply with regulatory ISO standards of medical device manufacture. This standard ensures that kit must be made of high-quality components assembled in the UK using a quality system for medical device manufacture - ISO13485:2016. Self-collect kits need to be UKCA marked (or dual marked with UKCA/CE) to represent product claims for the collection of samples in a non-clinic setting. Instructions provided in the kit should advise on process for collecting enough blood drops to fill the blood tube to the level shown in the instructions. Instructions provided are to ensure there is enough blood collected for laboratory testing. This is not a HOME TEST.
Self Testing (Shown on BBC News)
A home test provides an immediate result without being processed by a laboratory. This might be carried out using a kit considered to have been carried out using a quality collection device. There may be claims that the kit fulfils all the quality checks for the kit manufacture. There may be claims that the quality of test itself compares and performs with that of an ISO 15189 accredited clinical laboratory. There may be claims that the standards for collecting and testing at home are aligned with ISO13485 (for kit manufacture) and ISO13485 (for PSA testing).”
- Annette Wilkinson, Director of Business Development and Service, The Doctors Laboratory.
Amy Rylance from Prostate Cancer UK, interviewed on BBC Today 5th March rightly pointed out that the rise of PSA lateral flows is a response to a wider issue of the prostate cancer testing guidelines being outdated. She added that GPs need to be proactively reaching out to men at highest risk to offer testing.
Read the BBC article - https://www.bbc.co.uk/news/articles/cgl00gn15y8o
PSA testing is a great indicator of prostate health and we continue to support, fund and recommend these tests. Please note the clear difference between a lateral home testing kit, which we do not offer, and a self-collection home kit that we do offer.
Early detection saves lives. Book your PSA test TODAY.
Find a PSA testing event near you - https://tgfct.org.uk/Events/Our-Events
Our home kits - https://mypsatests.org.uk/Orders/