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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 that help 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. 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. Every test we sell must should be 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.

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 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 Health test kit complies with the Medical Devices Regulations 2002 (SI 2002 No 618). These regulations are the cornerstone of medical device safety in the UK. They align with the highest standards of patient safety and product quality.
• CE marking – A seal of approval: 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 guarantees that every kit is fit for its intended use and meets the relevant laws.
• Rigorous safety assessments: Before any of our self tests reach you, they undergo extensive safety assessments. Our manufacturer uses only medical-grade components, 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? We understand that our customers rely on the consistency of our tests to make informed health decisions. Reliability is the cornerstone of effective self-testing.

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

Checked by Notified Bodies

The tests we sell are vetted by Notified Bodies. These are independent organisations that check these products conform to the right rules and regulations.

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

Strict quality control

To maintain reliability, every phase of our manufactures follow ISO 13485:2016 standards. This is the international quality management system specific to the medical device industry.

This certification means that our suppliers not only meet but maintain strict quality controls over 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.

Ongoing auditing and checks

Beyond internal checks, our products are independently audited. These external reviews offer an extra layer of assurance, verifying that our manufacturers' practices and products remain meet the strictest safety and quality standards.

This all 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 makes sure Rezure Health 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 Health, 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 production: 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 labs, meaning that our tests are built on medical science.
• Clear instructions and support: Every Rezure Health 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 can help you 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.