Contact person
Jennifer Rosendahl
Projektledare
Contact Jennifer
Performance Evaluation according to IVDR
With the increased requirements in the new regulatory framework for in vitro diagnostic products (IVDR), it is more important than ever to ensure, before a diagnostic test is put into use, that it provides reliable results and is useful for both patients and users.
Performance Evaluation
Our analytical services are designed to help companies validate and verify the performance of their IVD products.
The reliability of a test can be described by its sensitivity and specificity. Sensitivity describes the test's ability to detect a condition in those who actually have the condition. High sensitivity is important in diseases where the consequence is great if the test does not find an individual who is sick. Specificity describes the test's ability to exclude the condition in those who do not have the condition. A test should have high specificity in diseases where, for example, the risks of a treatment are high.
We test the analytical performance according to the relevant standard to ensure that the products meet the new IVDR requirements.
Method
Our molecular biology laboratory has an extensive portfolio of methods for genetic, immunological, protein, chemical, and cell-based analyses. We use advanced instrumentation, including a NextSeq2000, multiple qPCR machines, plate readers, HPLC, LC-MS, GC, and a BD FACSMelody To ensure the highest possible quality of our analytical results.
We have a dedicated group of researchers and technicians with extensive experience and expertise in the field. By using a combination of state-of-the-art technology and proven methods, we always strive to deliver high-quality results that meet our customers requirements and needs.
Delivery
We are committed to delivering the best analytical services to ensure that our customers are well prepared for the future. Please feel free to contact us for more information on how we can help meet your requirements and needs.
