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So you have questions about self testing? Great!

Our goal is to help you better understand your own health through clear and accessible testing. Part of growing that understanding is answering the questions and concerns that will naturally arise as you learn more about the tests themselves.

In 2023, the UK’s Royal College of General Practitioners (RCGP) asked regulators to promote greater transparency around self-testing kits. In a statement, they expressed concern that without clear instructions and easily-interpreted results, “self-testing kits can lead to anxiety, unwarranted use of health services or false reassurance.”

We wholeheartedly agree with these doctors that self testing needs to be transparent and trustworthy. That's why we're committed to providing you with the most reliable tools to manage your health, ensuring every test is both user-friendly and scientifically sound.

To start demystifying self-testing, we want to answer some of your burning questions about the safety, reliability and accuracy of self tests.

How do I know self tests are safe to use?

It goes without saying that, when it comes to self-testing, your safety is our top priority. We have both a legal obligation and an ethical commitment to make sure that our testing kits not only adheres to but exceeds the strict requirements laid out by health authorities.

Here’s how we guarantee the safety of our self tests:

• Strict regulatory compliance: Every Rezure test kit complies with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended). These regulations are the cornerstone of medical device safety in the UK and align with the highest standards of patient safety and product quality.
• CE marking – A seal of approval: Spotting a CE mark on our products isn’t just a formality; it’s a promise. This mark confirms that our tests meet all EU regulations for health, safety, and environmental protection standards. The CE mark ensures that every kit is fit for its intended use and adheres to the relevant legal provisions.
• Rigorous safety assessments: Before any of our self tests reach you, they undergo extensive safety assessments. Our manufacturer uses only medical-grade components, like lancets and swabs, that are safe and suitable for home use. These assessments help ensure that every part of the kit is reliable and secure, reducing any risk of injury or incorrect usage.

Our commitment to safety doesn’t end when you open the box. We continue to support and educate on safe practices to ensure you can use our tests with confidence and ease, and that you get the most accurate results.

Can I be sure that these tests are reliable?

Why take a test if you can’t trust the outcome? Reliability is the cornerstone of effective self-testing. We understand that our customers rely on the consistency of our tests to make informed health decisions.

So how do we ensure that our tests are and remain dependable?

Validation by Notified Bodies

The tests we sell are vetted by Notified Bodies, independent organisations that check these products confirm to the correct regulations.

These bodies evaluate the test's design, manufacturing processes, and quality assurance systems to ensure they consistently produce accurate results. This validation is not a one-time event but an ongoing process that keeps standards high with every batch we receive.

Rigorous quality control

To maintain reliability, every phase of our manufacture’s process adheres to ISO 13485:2016 standards, the international quality management system specific to the medical device industry.

This certification requires that our suppliers not only meet but maintain rigorous quality controls that govern every aspect of production—from the initial design to the final inspection. This ensures each kit functions exactly as expected, every time it's used.

Continuous auditing and monitoring

Beyond internal checks, our products are subject to continuous independent auditing. These external reviews provide an additional layer of assurance, verifying that our manufacturer’s operational practices and products remain in compliance with the strictest safety and quality standards.

This comprehensive monitoring helps to detect and correct any problems before the tests reach you, the consumer. For us, this is all about safeguarding the reliability of every test we deliver.

What ensures Rezure tests are accurate?

When it comes to self-testing, you need to trust that the results you see reflect your true health status. At Rezure, we stake our reputation on providing tests that meet your expectations for accuracy.

Here's how we ensure each test delivers precise results:

• Scientific rigour in test development: Each test we stock is grounded in established scientific methods such as immunoassays, which are used to detect specific biomarkers associated with various health conditions. These methods are the same as those used in clinical laboratories, ensuring that our tests are built on a foundation of medical science.
• Comprehensive instructions and support: Every Rezure test kit comes with detailed, step-by-step instructions designed to be clear and easy to follow. To supplement our instructions, we provide access to our customer support team who are trained to assist with any questions about the testing procedure.

We know you’re bound to be curious about our tests, just as you’re curious about your own health. To explore your questions further, why not take a look at our range of self tests?

Safe, reliable, and backed-up by science, our tests offer a unique window into your health from the comfort of your own home.