Feature sponsored by Test & measurement
HOW SECURE ELECTRONIC AUTHENTICATION MITIGATES RISK AT THE POINT-OF-CARE
The growing adoption of rapid point-of-care (PoC) testing has significantly increased the number of in vitro diagnostic (IVD) tests being performed outside of the automated laboratory environment. This article from Aileen Cleary, marketing manager, Kris Panaro, field applications Engineer, and Chang Liu, business manager, Analog Devices, explores the security challenges associated with PoC diagnostics tests, the impact of reuse and misuse of patient samples, and how testing manufacturers can mitigate risk through secure electronic authentication.
Figure 1. The use of barcodes in PoC systems.
or many years, diagnostics testing performed on human samples was exclusively processed in clinical laboratories. The trend toward PoC testing is changing this by moving sample processing to the physician’s office, clinic, hospital, or even the home. PoC testing brings a clear benefit of achieving a faster time to diagnosis by removing the need to transport the patient sample to the centralised lab. It also has the potential to significantly improve workflows and provide more convenience to the patient. The need for robust PoC testing became significantly more evident during the COVID-19 pandemic when testing delays had a major impact on society and the spread of the virus during the early months of the pandemic. The trends toward PoC testing are here to stay, and diagnostic manufacturers are broadening their assay portfolio to include multiple targets, such as respiratory panels, sexually transmitted infections (STIs), bloodstream infections, and more. As this market expands, the number of patient samples processed outside of the laboratory setting is steadily increasing. Patient samples are now not only handled by professionals in closely controlled workflows but also by physicians in clinics and patients themselves in their homes, increasing the risk of misuse and reuse.
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CHALLENGES IN POC TESTING: THE RISK OF REUSE, MISUSE, AND COUNTERFEIT SAMPLES To fully achieve the benefits of PoC testing, the systems must produce a result that can be trusted by both patients and physicians alike. Measurement accuracy is a critical component of this, as without an accurate result, it is clear to see how misdiagnosis can occur. Even the highest accuracy test could result in the wrong diagnosis if the incorrect patient sample is processed. Providing a means to ensure that the correct patient samples are processed is therefore essential in creating a trusted result and reducing the risk of misdiagnosis. One major risk factor for patient samples is the potential for reuse. This can happen when a swab or cartridge is accidentally processed multiple times through the testing device. Imagine the scene of a busy kitchen with a large family, all taking home tests prior to the morning school run. It is easy to see how a parent could accidentally reuse one child’s swab in place of another. This risk also exists in the clinic or in the growing number of CLIA-waived labs that do not require trained laboratory technicians to perform the diagnostic tests.
A second key risk is the potential for intentional misuse of patient samples. For certain tests, such as the identification of the presence of illegal drugs, patients may be motivated to falsify results. Switching the sample cartridge prior to processing is one way of achieving this. Another challenge to obtaining accurate results is the availability of counterfeit cartridges in the market. In the traditional lab environment, purchasing is done through qualified channels.
38 August 2023 Instrumentation Monthly
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