In vitro diagnostics - the importance of in vitro diagnostics for patient management and the health of society
In vitro diagnostic medical devices (IVDs) play a central role in healthcare and make a significant contribution to individual patient management and the overall health of society.
What’s the definition of an IVD?
By definition, IVD refers to tests performed on samples taken from the human body, such as blood, urine, cerebral fluid, tissue, or other puncture fluids. The term "in vitro" means "in the glass" and indicates that these tests are carried out outside the living organism. In most cases, these tests are performed by professionals in a typical laboratory environment in medical laboratories, hospitals, or blood donation and transplant centres.
Professional use
These laboratory-based tests, also classified as "professional use tests" by regulation, are often used for complex diagnoses. It is not uncommon for these types of tests to be fully automated, such as in the laboratories of blood banks for the determination of pathogens relevant to transfusion medicine, and are carried out on large equipment in high throughput. However, there are also IVDs that are requested in the area of a rather special, rare question. The technological range is correspondingly high. Typical types of tests in the field of "professional use" use a wide variety of technologies for the detection of DNA or RNA, such as the very common PCR tests or – currently still rarer – next-generation sequencing tests (NGS). Various types of immune tests are used to determine antibodies. For the large field of clinical chemistry, several other technologies are added.
Point-of-care and self-tests
The "point-of-care tests" (POCT) or "near-patient tests" (NPT) have a somewhat different function. These are carried out at or near the point of patient care and allow for faster diagnosis and treatment decisions. They are usually carried out by medically trained personnel. The self-tests, on the other hand, are carried out by medical laypeople in the home environment. Both groups are subject to special, additional requirements on design and instruction for use, which result, for example, from a higher risk of application errors.
Clinical decisions are supported by the results of the IVD
IVDs are indispensable in modern healthcare for the diagnosis of diseases. They provide data that helps clinicians identify the presence of diseases. In particular, diseases that cannot be clearly identified on the basis of the symptoms – and this includes the majority of them – require a careful, sometimes complex, differential diagnostic laboratory examination. It is assumed that in 60 to 70% of cases, a clinical decision is supported by the use of specific IVDs.
A fast, reliable and, above all, correct diagnosis is the basis for effective treatment of the individual patient. IVDs are also used to track the course of a disease and the patient's response to treatment. This continuous monitoring is critical to managing chronic conditions and ensuring the long-term effectiveness of treatments. Completely individual treatment decisions can often be made on the basis of different, interlocking laboratory results in the context of personalized medicine. IVDs are also indispensable for this increasingly important field.
For public health, IVDs play an important role in the early detection and prevention of diseases and thus prevent the uncontrolled spread of infectious diseases. The identification of diseases at an early stage enables timely intervention, which can significantly reduce transmission rates – in times of the COVID-19 pandemic, both professional PCR laboratory tests and rapid tests were used extensively.
Without good diagnostics, it will be expensive
The cost savings in the healthcare system through precise, fast and reliable diagnoses, to which IVDs contribute, are considerable in the course of growing total costs for the expenditure of health insurance companies and ensure affordable and high-quality care in the long term.
Innovative and indispensable
The IVD industry, like the entire medical device industry, is experiencing significant technological advances, especially in areas such as next-generation sequencing (NGS), microfluidics, artificial intelligence (AI), and lab-on-a-chip technologies. These innovations improve the precision, speed and accessibility of diagnostic tests. The integration of digital health technologies, including AI, mobile health apps, and wearable sensors, creates new opportunities and may significantly change the design of IVDs. For example, these technologies enable real-time monitoring and provide valuable insights into patients' health, improving the diagnostic process. Great progress has also been and is being made in the field of oncology and dementia diagnostics.
In conclusion, in vitro diagnostic medical devices are a cornerstone of modern healthcare and offer significant benefits for patient management and society as a whole. Their role in diagnosis, treatment selection, and monitoring is critical to improving patient outcomes and healthcare system efficiency. As the field continues to evolve with technological advancements and a focus on personalized medicine, IVDs are poised to play an even more significant role in shaping the future of healthcare, helping to improve public health, economic efficiency, and overall societal well-being.
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