Point-of-care diagnostics (POCT) is becoming increasingly important, while at the same time the number of available devices and providers is growing. For many parameters, several POCT systems are available today, which provide comparable performance data at first glance.

This shifts the central challenge: away from the question of whether a parameter can be measured to the question of which device is the best choice in the specific context of use.

Why analytical performance data alone is not enough

In practice, the selection usually begins with a specific analyte. Further differentiation is often based on key figures such as sensitivity, specificity or precision. These are essential, but primarily reflect technical performance under controlled conditions.

However, other questions are crucial for everyday care:

• How does the device work in real use?
• How well can it be integrated into existing processes?
• What impact does it have on clinical decisions?

This is where different types of studies come in, which go beyond pure analysis.

Four study types that are crucial for selection

Application studies (handling & workflow)
Evaluate practical use in everyday life, in particular usability, training effort and susceptibility to errors. This is particularly crucial in the POCT sector, as the devices are often used by non-laboratory specialists.

Laboratory evaluations (compared to the central laboratory)
Examine compliance with reference methods and provide the basis for confidence in the measurement results.

Comparative studies (system vs. system)
Enable direct comparison of multiple POCT instruments – both in terms of analytical performance and practical aspects such as turnaround time or sample handling.
Particularly relevant: differences in cut-offs, operating concepts and training effort in the event of a possible changeover.

Health economic studies
Evaluate the influence on processes, resources and costs, e.g. with regard to hospital stays or therapy decisions.

Challenge: Too many studies, too little structure

Although this evidence exists, it is often used only to a limited extent in practice. Studies are spread across different sources, difficult to compare and time-consuming to analyze.

In addition, different study designs and endpoints make interpretation difficult. New approaches therefore use artificial intelligence to summarize studies in a structured way and make them comparable. AI-powered summaries make it possible to gain an overview of the performance of POCT devices more quickly.

Increasing market diversity as an additional challenge

In addition to established manufacturers, new suppliers are increasingly entering the market. Many of these systems show comparable analytical performance in studies, but are less visible in everyday clinical practice, often due to limited sales and marketing structures.

For users, this means that relevant innovations are potentially not taken into account, even though evidence-based data is available.

Structured market transparency as a solution

Against this background, approaches that systematically combine both evidence and market overview are gaining in importance. This includes:

• Structured preparation of studies (incl. AI summaries)
• Comparability between devices
• Visibility of both established and new vendors

In addition, the practical application can be made transparent through independent, video-based demonstrations. This gives users a realistic impression of the workflow and operation – regardless of on-site appointments. Digital assistance systems also enable product-specific questions to be answered continuously.

Conclusion

The selection of POCT devices today is an evidence-based decision that goes beyond analytical metrics. Only the interaction of different study types enables a well-founded assessment in a clinical context.

At the same time, the increasing variety of devices and providers requires new ways to make evidence accessible and comparable.

For more information, as well as a structured overview of POCT devices, studies, and AI-powered summaries, visit www.diagnoodle.com.

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