Point-of-Care Prostate Specific Antigen Testing: Examining Translational Progress toward Clinical Implementation

Abstract

Prostate cancer (PCa) is the second most common male cancer and is attributable to over 375,000 deaths annually. Prostate specific antigen (PSA) is a key biomarker for PCa and therefore measuring patient PSA levels is an important aspect of the diagnostic pathway. Automated immunoassays are currently utilized for PSA analysis, but they require a laboratory setting with specialized equipment and trained personnel. This results in high diagnostic costs, extended therapeutic turnaround times, and restrictions on testing capabilities in resource-limited settings. Consequently, there is a strong drive to develop point-of-care (PoC) PSA tests that can offer accurate, low-cost, and rapid results at the time and place of the patient. However, many emerging PoC tests experience a trade-off between accuracy, affordability, and accessibility which distinctly limits their translational potential. This review comprehensively assesses the translational advantages and limitations of emerging laboratory-level and commercial PoC tests for PSA determination. Electrochemical and optical PSA sensors from 2013 to 2023 are systematically examined. Furthermore, we suggest how the translational potential of emerging tests can be optimized to achieve clinical implementation and thus improve PCa diagnosis globally.

A review of antibody, aptamer, and nanomaterials synergistic systems for an amplified electrochemical signal

“…The critical characteristics of PoCT should match its users’ clinical and individual needs ( Korte et al, 2020 ). Among the crucial factors described by Garg et al (2023) that affect the translation of research output to PoCT are listed in Table 3 .…”

“…Most electrochemical techniques require at least 30 min to allow ample time for sample incubation. However, this does not include the time to obtain, collect, and pre-process samples ( Garg et al, 2023 ).…”

Phage Display’s Prospects for Early Diagnosis of Prostate Cancer

“…New urgent requirements for fast, sensitive, accurate, and inexpensive tools for the early diagnosis of PC devalue the traditional PSA detection methods [ 16 ], such as ELISA, radioimmunoassay immunoradiometric assay, and time-resolved immunofluorescence assay, which have a complex operation, are difficult to miniaturize, and can have a limited sensitivity [ 23 , 24 , 25 , 26 ]. Modern immunoassays and biosensors require a biorecognition probe, which is attached to the interface of the analytical device, bind the target biological ligand, and participate in generating a measurable signal [ 13 , 14 , 27 , 28 ], as illustrated in Figure 1 .…”

“…Therefore, there is an urgent need for standard, sensitive, robust, and commonly available screening tools for the identification of early signs of cancer pathologies [ 9 ]. In this respect, the “Holy Grail” of cancer researchers and bioengineers for decades has been molecular sensing probes that would allow for the diagnosis, prognosis, and monitoring of cancer diseases via their interaction with tumor-associated cancer cells and/or blood-solubilized PC biomarkers, such as the prostate-specific antigen (PSA), the prostate cancer antigen 3 gene (PCA3), and sarcosine oxidase [ 2 , 10 , 11 , 12 , 13 , 14 , 15 , 16 ]. At present, most PSA tests are performed at centralized laboratories using high-throughput total PSA immune analyzers.…”

“…Furthermore, an important limitation of PSA analyzers is that they are suitable for dedicated laboratories and are not readily available for the broad healthcare community. Therefore, the emerging trend in the screening and detection of PC is using portable biosensors for mobile laboratories and individual use [ 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 ]. Phage display, since its conception by George Smith, in 1985 has emerged as a premier tool in molecular biology with widespread application.…”