The quality of the home health tests

Sanotest is all about the quality. We provide reliable health tests for testing at home of the highest quality exclusively.

Sanotest Quality Guarantee

As with any device, it can happen also with health tests for testing at home (devices for self-testing*) to not function properly. Such cases are very rare, but if it happens to you, do not worry, we have got you covered.

Causes of errors can be technical, but mostly the cause is a human error (this is why following instructions for use strictly is so important). Every test has an internal control incorporated to validate whether a test functions properly. If any test will not function properly, we will replace it to you free of charge.

Certified quality

The tests correspond to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices and hold IVD mark.

*“device for self-testing” means any device intended by the manufacturer to be able to be used by laypersons in a home environment (Directive 98/79/EC).

Safety and quality are non-negotiables in the medical devices industry (https://www.iso.org/iso-13485-medical-devices.html). The tests are manufactured and maintained under strict conditions set by quality management system standard ISO 13485.

The tests are safe to use (please follow instructions for use carefully), and give you highly accurate results in just 10 minutes on average (time to read a result depends on the test itself).

Superior reliability and accuracy

The reliability and high accuracy of the tests have been demonstrated by clinical trials (number of samples in the trial and comparison method depends on the test assessed). Besides, each new production batch is evaluated to meet the high-quality standard.

The tests are based on the latest scientific advances in the field of nanotechnology. The sensitivity of the tests has increased with the use of gold nanoparticles, 5-200 nanometers (10-9) in size. Thanks to science, especially due to such high sensitivity, we can today control our health also ourselves at home.

Scientific advances enabled as well:

  • very high accuracy of the tests, with cases up to 100 % (proven in laboratory trials),
  • safe, easy and quick self-testing at home (supported by clear and easy-to-follow instructions for use),
  • results known in 5-10 minutes (with most of the tests).

Tests are also used by healthcare professionals worldwide

In daily health testing routine, rapid tests based on the same technology than tests we offer at Sanotest, have been used for many years by healthcare professionals in doctor offices and laboratories worldwide (POCT – Point of care testing). They are affordable, fast, highly reliable, and easy to use.

Home health tests of trusted origin

The health tests at Sanotest are of trusted origin and meet the highest quality standards in the field of diagnostic medical devices.

Every test is labelled with information on the manufacturing plant and its origin. Manufacturing plants are in the United Kingdom, France, Germany, Austria and the United States of America.

Questions?

Did we miss something? Please do not hesitate to contact us for any questions you might have about the quality of the tests or any other.

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