Over-reliance on simulation
The study uses simulated data for a substantial portion of its analysis, particularly in demonstrating the extended dynamic range. While simulations can be valuable tools, relying heavily on them without extensive experimental validation raises concerns about the real-world performance of the sensor, especially given the complexities of biological samples and potential variations in fabrication.
POC claim but complex setup
The authors claim to have developed a point-of-care (POC) device, yet the current setup requires equipment like a laser diode module, objective lens, Wollaston prism, analyzer, and a CMOS camera connected to a computer running custom MATLAB scripts. This complex setup is far from the simplicity and portability expected of a true POC device, limiting its practical applicability in resource-limited settings.
Lack of validation with complex biological samples
While the sensor demonstrates promising sensitivity to PCT in a controlled laboratory environment, its performance in complex biological fluids like blood or serum, which contain a multitude of other proteins and molecules, remains unproven. The authors acknowledge the need for future work with clinical samples, but without this crucial validation, the sensor's true diagnostic utility remains uncertain.
Reliance on a single biomarker
The study focuses solely on the detection of PCT, a single biomarker. While PCT can be informative, relying on a single marker for complex diagnoses like bacterial vs. viral infections can be misleading. A more robust POC diagnostic would ideally incorporate multiple biomarkers to improve diagnostic accuracy and account for individual patient variability.