In our journal In Vitro Diagnosis, a special issue is calling for papers about IVD test kits.

Health care providers rely on a variety of tools to diagnose conditions and guide treatment decisions. The most common and widely used of these are in vitro diagnosis (IVD), which are clinical tests that analyze samples taken from the human body. Patients may accept or forgo medical care based on the results of a diagnostic test, so the reliability of the test is critical.

In vitro diagnostic (IVD) test kits consist of materials used to determine the results of a specific test. However, they are subject to a very different level of scrutiny. IVD regulation is risk-based, with tests falling into one of three regulatory categories, from the lowest Class 1 to the highest risk tier, Class 3. This creates distortions in the diagnostics market, prevents regulators from gaining a full understanding of the tests used in clinical practice, and puts patients at increased risk of making consequential and perhaps irreversible medical decisions based on inaccurate test results.

Neither the advantages nor the disadvantages can be described as satisfactory, and their constant repetition suggests a lack of clinical perspective and advanced advice on experiential issues. In this issue, we would like to call for papers on IVD test kits, where topics could beclinical applications, IVD test kit types, related diseases, advances in kits, regulations about IVD tests in different countries, etc.

clinical applications, IVD test kit types, related diseases, advances in kits, regulations about IVD tests in different countries, etc.