What are in vitro diagnostic (IVD) products?

Healthcare providers utilize data to recognize medical conditions and subsequently make treatment decisions informed by that data. This approach is essential for effectively assisting patients on their journey toward relief or recovery. Additionally, disease prevention constitutes a significant aspect of healthcare providers' responsibilities. For instance, the early identification of elevated cholesterol levels plays a crucial role in combating cardiovascular diseases. Similarly, the detection of specific DNA sequences can reveal the presence of latent diseases. A variety of tools are available for these purposes, with in vitro diagnostic products (IVDs) being the most prevalent.

IVDs encompass clinical tests designed to analyze human bodily fluids, including blood, urine, and saliva. Their primary objective is to assess the concentration of particular substances, such as sodium and cholesterol, identify specific markers, or detect antibodies in response to infections, such as COVID-19. IVDs come in various forms, ranging from pregnancy tests to genetic tests aimed at identifying certain cancer types. Companion diagnostics, which are medical devices that forecast a patient's potential benefit from personalized medication, also fall under the category of IVDs. This area of companion diagnostics represents a specialized field of expertise that we actively engage in.

IVD Products Available

IVD as a comprehensive term

In Vitro Diagnostics (IVD) is a comprehensive term encompassing both the reagents and the associated measuring instruments, which include both hardware and software components. The term 'any' is significant, as not all IVD tests necessitate the use of devices; while hardware and software systems are frequently employed in hospital laboratories, certain IVD tests, such as pregnancy tests, are conducted manually. IVD tests can be categorized into self-tests, Point of Care tests for healthcare providers, and laboratory tests, all of which are included under the IVD classification.

IVDs are classified into three distinct categories based on the level of risk that inaccurate results may pose to patients and public health:

I. Relatively low risk (e.g., cholesterol test)

II. Moderate risk (e.g., pregnancy test)

III. Highest potential risk (e.g., HIV test)

It is noteworthy that Future Diagnostics specializes in the development of IVD products. Our primary focus is on creating products within the third risk category, as the accuracy of category III tests is of paramount importance in the medical field. Our emphasis on immune analyses has allowed us to excel in this domain for many years, equipping our team to effectively address the most significant risks. Through this approach, we are diligently advancing our mission: to foster a world where our clients can assist healthcare professionals globally in their pursuit of optimal healthcare for all.

IVD Products Available