Feature sponsored by Test & measurement
Figure 2. The use of mechanical features in PoC systems.
device as inaccurate, or in a worst-case scenario, triggering a product recall. The prevalence of counterfeit cartridges poses a significant business risk to device manufacturers with the potential to disrupt the lucrative disposable revenue stream obtained from the sample cartridge.
WHY TRADITIONAL SOLUTIONS FALL SHORT OF MITIGATING RISK IN POC TESTING
For home-based PoC testing, patients are often purchasing tests directly from major online retailers. This opens the door to counterfeit suppliers who may have lower quality products leading to less accurate results. Lab environments are not immune to misuse. After use, sample kits used in the lab are discarded as medical waste. When this medical waste is collected by a third party, there is a risk for sample kits to be refurbished and resold to the test lab. Unknown to the lab, the refurbished kits may appear to be new but will either have no reagents or simply be refilled with water. This
can contribute to false test results that can lead to the improper treatment of the patient. The impact of both reuse and intentional misuse of patient samples can be felt by patients and device manufacturers alike. Patients can experience a misdiagnosis - for example, a false positive test resulting in unnecessary disruption and unnecessary treatment. A false negative would conversely result in delayed diagnosis and ultimately a delay or absence of correct treatment. Device manufacturers can also pay a heavy price in the form of damage to their brand reputation, the unfair labelling of their
There are two traditional methods for ensuring the authenticity of patient samples. One method is labelling, such as 1D or 2D barcoding. The second method utilises mechanical features that prevent the reinstallation of a cartridge. The use of 1D and 2D barcodes is the favoured method of sample tracking in the laboratory environment. Batch information, serial numbers, and unique device identification can be used to ensure the authenticity of the cartridge. In addition, barcodes can be reviewed prior to sample processing to ensure that reuse has not occurred. Although barcodes provide a robust means of ensuring the authenticity of the patient sample, they have limitations. Firstly, barcode labels require a barcode scanner, which places a burden on the design of the instrument due to size and focal length requirements. Barcodes also require significant memory to store sufficient serial numbers to prevent reuse. While this may not be an issue in large laboratory equipment, it is a cost and size challenge for compact PoC equipment. Critically, barcodes are visible to the user, making them less secure and prone to be copied or forged.
The second traditional method is the use of a simple mechanical feature, such as a notch in
Continued on page 40... Figure 3. Electronic authenticator ICs in PoC systems.
Instrumentation Monthly August 2023
39
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