Performance evaluation at IVD: Quality assurance in the health sector
In the world of medicine and healthcare, the quality of diagnostic procedures is crucial. This is where in vitro diagnostic (IVD) products come into play, which are used to test in vitro samples from patients to obtain medical information on their health status. Performance evaluation of IVD products is an indispensable process to ensure that these products are accurate, reliable and safe in their analytical results. Regulations such as the IVDR place high demands on this performance evaluation.
In this blog article, we will go into more detail about why performance evaluation of IVD products is so important and how it improves quality and efficiency in healthcare.
What are in vitro diagnostics?
In vitro diagnostics are medical tests and procedures that are performed outside the patient’s body. This includes a wide range of tests, from blood tests to urine and tissue samples. IVD products are used to diagnose diseases, monitor the progression of diseases, make treatment decisions and monitor overall health. They form the basis of modern medicine and play a crucial role in providing accurate and reliable health information.
An exemplary product in the field of in vitro diagnostics (IVD) is SARS-CoV-2 tests, which are used to detect the virus responsible for COVID-19. These tests involve taking a sample from the body of the person being tested, typically a nasal or throat swab, with the aim of detecting the pathogen in the sample.
The three cornerstones
Proof of scientific validity
While the two cornerstones of scientific validity and analytical performance leave little to no questions unanswered, it is a bit more complicated with the clinical performance evaluation. But from the beginning:
Demonstrating scientific validity means proving that a particular test or marker is actually related to a particular health condition. This evidence is usually based on published peer-reviewed scientific literature. If such literature does not exist, research must be conducted.
Analytical performance evaluation
Analytical performance evaluation refers to how well a device is able to correctly detect or measure a specific substance. To demonstrate the quality of this analytical performance, certain parameters must be substantiated according to the IVDR. In order to demonstrate that a product meets the analytical performance, in-house performance studies must be conducted. This is done in accordance with common standards or specific regulations.
Clinical performance evaluation
Clinical performance evaluation refers to “the ability of a device to provide results that correlate with a specific clinical condition or physiological or pathological process or state in a specific target population and specific intended users” (IVDR, Article 2 (41)).
In some cases, it is even possible to dispense with separate clinical performance studies. However, this is only possible in certain cases. Relevant factors are the clinical function of the product, the risk class and the novelty of the IVD. Deciding whether a study is necessary for one’s own IVD is not so easy, however, and is usually done on a case-by-case basis.
Why performance evaluation of IVD products is so important
It is important that IVD products are accurate and reliable. Let’s look at the reasons why.
First, performance evaluation is important for patient safety. It ensures that the results of IVD products are valid and reliable. Faulty or inaccurate test results can have serious consequences for patient safety by leading to wrong diagnoses or incorrect treatment.
IVD products are performed in various medical facilities and laboratories around the world. Performance evaluation ensures a consistent quality standard of tests regardless of their location. This is critical for comparability of results and ensuring overall quality in healthcare.
Thorough performance evaluation of in vitro diagnostics also enables manufacturers to improve existing tests and develop new ones. This promotes innovation in healthcare and helps discover new diagnostic and treatment options.
Also of importance is that there are strict regulatory requirements for IVD products in many countries. The risk class and performance evaluation are often a key criterion for the approval and sale of such tests on the market.
Conclusion
Performance evaluation of in vitro diagnostics is a critical step in ensuring that the healthcare industry provides accurate and reliable health status information. It helps to ensure patient:internal safety, improve quality in healthcare and drive innovation. For the future of healthcare, IVD performance assessment remains critical, ensuring that we can count on accurate and reliable diagnoses and tests to protect and improve the health of people worldwide.
How we support you
With BAYOOSOFT Themis you digitize linked processes and sustainably reduce documentation efforts while minimising redundant data. In this way, you maintain an overview of your required evidence and documents when it comes to performance evaluation and thus comply with the regulations.
Curious? Find out more here.