Point of care diagnostics – simply & compact

The term point of care diagnostics, which in German means laboratory diagnostics close to the patient, is understood to mean medical diagnostics that cannot be carried out in a central laboratory, but directly in the hospital, a practice or a registered office. In certain cases, the use of point-of-care diagnostics is also conceivable outside of the corresponding facilities, for example in a patient's home or in an ambulance. Some tests are also intended for private use. This includes, for example, pregnancy tests or blood sugar measurements for diabetics.

Many people in this country are familiar with point-of-care diagnostics, mainly because of its use during the Covid pandemic in the form of rapid test kits. During the pandemic, point-of-care diagnostics played a key role in effectively containing infections. This form of diagnostics offers huge potential that is worth taking a closer look at. For this reason, we have compiled everything that is important about point-of-care diagnostics below and recorded the special requirements that result from this in the field of medical technology design.

In general, there is no uniform definition of point-of-care diagnostics. However, there is a consensus in medical technology about the essential properties of PoC technology. The basic characteristics of point of care diagnostics are as follows:

The first advantages can already be seen from the essential properties of point-of-care diagnostics. Point of care diagnostics is very fast. The results are therefore available after just a few minutes. This speed is mainly generated by the fact that the transport to a laboratory and their specific work processes are no longer necessary. As a result, the average time until a result is available is between 5 and 15 minutes. This time advantage compared to other diagnostic methods is particularly important in areas in which well-founded decisions must be made quickly. Therefore, point-of-care diagnostics are mainly used in intensive care units and outpatient clinics. The PoC tests used check so-called emergency parameters such as electrolytes, blood gas and blood coagulation values, heart enzymes, etc. Many PoC tests are designed as simple test strips, which significantly reduces manual effort and is therefore easy to implement even for laypeople.

Of course, point-of-care diagnostics does not only offer advantages. A disadvantage consists above all in the high reagent costs and a lower sensitivity and accuracy, which is often due to the method used. In addition, the sample throughput is usually significantly lower than with corresponding laboratory methods and corresponding rapid test methods are only available for a few parameters.

How exactly point of care diagnostics work cannot be answered simply, as there are a wide variety of tests and methods. Using the rapid test for detecting Covid-19, is an example of how point-of-care diagnostics can work. Quick- and self-tests belong to the so-called antigen tests and show protein structures of the corona virus. For this purpose, a swab is taken from the nose and throat with a stick and placed on a test strip together with a liquid (reagent liquid). This in turn reacts to protein components of the virus and indicates this by discoloration. The result is already available after 15 minutes. Antigen tests are also called PoC antigen tests and are therefore part of point-of-care diagnostics.

And how does a PCR test work? With the PCR technology, a sample is also taken. The genetic material of the virus is then greatly amplified in the laboratory, which means that a Covid infection can be detected even if only a small amount of virus was originally present. The PCR test is therefore often referred to as the gold standard of Covid tests. On the other hand, there is a long waiting time until the result. In contrast to point-of-care diagnostics, the result can only be viewed after 24 to 48 hours. So there are differences in ergonomics and usability here.

In connection with point-of-care diagnostics, packaging and labeling play a particularly important role in medical technology design. In order for the test to be used correctly and deliver valid results, appropriate and easily understandable instructions must be included or printed on the packaging. This way, incorrect use and thus false positive or negative results are prevented. Packaging and labeling is often associated with a number of challenges. If your own products are sold internationally, different labels are often required due to cultural and socio-economic differences. A formative evaluation is therefore required for medical devices of any kind.

If you have any further questions about point-of-care diagnostics and its importance for medical technology design, please feel free to contact us at any time. We look forward to your inquiry.