Search Results (65)

Introduction: The multigene molecular testing of prostate cancer tissue after biopsy provides individualized information to guide further management. The utility of selective genetic testing for MRI-visible target versus systematic cancer in patients as well as during different time points of active surveillance (AS) is unknown. The objective of this study was to compare Prolaris^TM results of MRI-target cancers versus systematic cancers on prostate needle biopsy as well as both during consideration for initial AS candidacy and candidacy for remaining on AS. Methods: Our prospectively maintained institutional multiparametric (mp) MRI prostate cancer active surveillance database (2013–2024) was queried for patients that underwent Prolaris^TM genetic testing of positive biopsy cores. Baseline information for PSA, PSA density, and Prolaris^TM calculated data were collected. Information on the timing of the Prolaris testing, defined as during the initial cancer diagnostic biopsy or on a subsequent confirmatory biopsy was collected. SPSS v29.0 was used to compare the selective Prolaris^TM results of MRI-target cancers versus systematic cancers during different points of AS. Results: 264 patients with a Prolaris^TM test were identified, 86 with MRI-target and 178 on systematic cancers. 182 Prolaris^TM tests were sent on a diagnostic biopsy and 81 on a subsequent biopsy. Overall, MRI-target cancers had similar risk scores (3.23 vs. 3.14, p = 0.18). Prolaris^TM scores were higher for GG2 systematic than GG1 target cancers (3.40 vs. 3.18, p = 0.023). The GG2 systematic lesion cohort also had higher predicted the 10-year disease-specific mortality (DSM) (3.40% vs. 2.30%, p < 0.01) and 10-year metastasis risk (1.90% vs. 1.20%, p = 0.013), and more aggressive recommended treatment. Analyses of the Prolaris^TM results sent during a diagnostic biopsy yielded similar results. Finally, on an analysis of the Prolaris^TM results sent during subsequent biopsy, a systematic GG2 biopsy was noted to have a higher 10-year DSM and metastasis rate, but similar risk scores and treatment recommendations. Conclusions: Prolaris^TM tests can be sent at multiple time points of AS, and selectively for MRI-visible versus higher grade cancers. There is no consistent association between MRI-visible cancer and Prolaris risk profile. When utilizing multigene molecular testing in prostate cancer, each individual patient must be evaluated to decide the appropriate level of care. Full article

The rising global burden of chronic diseases and cancer in the workplace has intensified the need for accessible, rapid diagnostic strategies within workplace settings. Point-of-care testing (POCT) offers a decentralized solution, providing timely diagnostic insights without the need for centralized laboratory facilities. In the workplace, POCT offers significant advantages for early detection and management of cancer and chronic diseases, improving employee health outcomes and reducing absenteeism. Concurrently, the development of digital health passports has created secure, dynamic platforms for managing and sharing personal health data. This review explores the technological innovations underpinning POCT, examines its application in workplace health screening, and analyzes how integration with the Internet of Things (IoT) and digital health passports can enhance early detection and chronic disease management. The discussion extends to the ethical, regulatory and practical challenges associated with implementation. Furthermore, emerging trends such as artificial intelligence-driven diagnostics, blockchain-enabled data security and wearable biosensors are considered as potential future directions. Together, POCT and digital health passports represent a significant evolution towards proactive, personalized workplace healthcare systems. Full article

Breast cancer is a leading cause of cancer-related mortality worldwide, requiring efficient diagnostic tools for early detection and monitoring. Human epidermal growth factor receptor 2 (HER2) is a key biomarker for breast cancer classification, typically assessed using immunohistochemistry (IHC). However, IHC requires invasive biopsies and time-intensive laboratory procedures. In this study, we present a biosensor integrated with a reusable printed circuit board (PCB) and functionalized glucose test strips designed for rapid and non-invasive HER2 detection in saliva. The biosensor achieved a limit of detection of 10⁻¹⁵ g/mL, 4 to 5 orders of magnitude more sensitive than the enzyme-linked immunosorbent assay (ELISA), with a sensitivity of 95/dec and a response time of 1 s. In addition to HER2, the biosensor also detects cancer antigen 15-3 (CA15-3), another clinically relevant breast cancer biomarker. The CA15-3 test demonstrated an equally low limit of detection, 10⁻¹⁵ g/mL, and a higher sensitivity, 190/dec, further validated using human saliva samples. Clinical validation using 29 saliva samples confirmed our biosensor’s ability to distinguish between healthy, in situ breast cancer, and invasive breast cancer patients. The system, which integrates a Bluetooth Low-Energy (BLE) module, enables remote monitoring, reduces hospital visits, and enhances accessibility for point-of-care and mobile screening applications. This ultra-sensitive, rapid, and portable biosensor can serve as a promising alternative for breast cancer detection and monitoring, particularly in rural and underserved communities. Full article

Prostate cancer is the second leading cause of cancer-related deaths among men in the United States. The early detection of aggressive forms is critical. Current diagnostic methods, including PSA testing and biopsies, are invasive and often yield false results. MicroRNA-141 (miRNA-141) has emerged as a promising non-invasive biomarker due to its elevated levels in the urine of patients with metastatic prostate cancer. Here, a low-cost, paper-based electrochemical biosensor for the sensitive detection of miRNA-141 in synthetic urine is reported. The device employs inkjet-printed gold electrodes on photopaper, functionalized with thiolated single-stranded DNA-141 capture probes for specific target recognition. The biosensor achieves a sensitivity of 78.66 fM µA⁻¹ cm⁻² and a linear detection range of 1 fM to 100 nM, encompassing clinically relevant concentrations of miRNA-141 found in patients with metastatic prostate cancer. A low limit of detection of 2.15 fM, strong selectivity against non-target sequences, and a rapid response time of 15 min further highlight the diagnostic potential of the device. This platform represents a significant advancement in the development of point-of-care diagnostic tools for prostate cancer and is readily adaptable for detecting other disease-specific miRNAs through simple probe modification. As such, it holds broad promise for accessible, early-stage cancer detection and longitudinal disease monitoring in diverse clinical settings. Full article

The technology of digital polymerase chain reaction (dPCR) is rapidly evolving, yet current devices often suffer from bulkiness and cumbersome sample-loading procedures. Moreover, challenges such as droplet merging and partition size limitations impede efficiency. In this study, we present a super-hydrophilic microarray chip specifically designed for dPCR, featuring streamlined loading methods compatible with micro-electro-mechanical systems (MEMS) technology. Utilizing hydrodynamic principles, our platform enables the formation of a uniform array of 120-pL independent reaction units within a closed channel. The setup allows for rapid reactions facilitated by an efficient thermal cycler and real-time imaging. We achieved absolute quantitative detection of hepatitis B virus (HBV) plasmids at varying concentrations, alongside multiple targets, including cancer mutation gene fragments and reference genes. This work highlights the chip’s versatility and potential applications in point-of-care testing (POCT) for cancer diagnostics. Full article

This article explores the development and application of innovative piezoelectric sensors in point-of-care diagnostics. It highlights the significance of bedside tests, such as lateral flow and electrochemical tests, in providing rapid and accurate results directly at the patient’s location. This paper delves into the principles of piezoelectric assays, emphasizing their ability to detect disease-related biomarkers through mechanical stress-induced electrical signals. Various applications of piezoelectric chemosensors and biosensors are discussed, including their use in the detection of cancer biomarkers, pathogens, and other health-related analytes. This article also addresses the integration of piezoelectric materials with advanced sensing technologies to improve diagnostic accuracy and efficiency, offering a comprehensive overview of current advances and future directions in medical diagnostics. Full article

Background/Objectives: This work introduces accuracy- and precision-ROC curves in addition to SS– and PV–ROC curves and shows a novel means of profiling biomarker characteristics for validation of optimal cutoffs in clinical diagnostics and decision making. Methods: This investigation included 91 patients with a confirmed bladder cancer diagnosis and 1152 patients without evidence of cancer. The study performed a quantitative investigation of used-up test cassettes from the visual UBC^® Rapid qualitative point-of-care assay, which had already been applied in routine diagnostics. Using a photometric reader, quantitative data could also be obtained from the test line of the used cassettes. The ROC curves were constructed using different thresholds or cutoff levels to determine the TP/TN and FP/FN values for each threshold at concentrations of 5, 10, 30, 50, 90, 110, 250 and 300 µg/L. The resulting TP/TN and FP/FN values were used to calculate the sensitivity/specificity, accuracy, precision and predictive values in order to plot the ROC curves with integrated cutoff value distributions and their index cutoff diagrams. Results: A common, optimal cutoff value for all the diagnostic parameters was derived with the aid of an ROC index cutoff diagram. It includes higher specificity and an acceptable number of NPVs. As a result, use of a sensitivity–specificity ROC curve and the Youden index only permits the selection of a maximal threshold value or cutoff point for the biomarker of interest but disregards the clinical status of the patient, whereas the precision, accuracy and predictive values give information related to the disease. Conclusions: This work’s novelty compared to the existing methodology includes the first international publication of accuracy- and precision-ROC curves. It enables the investigation of the relationship among the sensitivity, specificity, precision, accuracy and predictive values at varied cutoff levels within a bioassay, presenting these in a single graph consisting of selected receiver operating characteristic (ROC) curves for each parameter, including cutoff distribution curves. This is a transparent method to identify appropriate cutoffs for multiple diagnostic parameters. According to the results, the single-sided use of a sensitivity–specificity ROC curve including the maximal Youden index value as an optimal cutoff or single-point determinations for predictive values cannot provide diagnostic information of the same quality as that given by a multi-parameter diagnostic profile and a multi-parameter cutoff-index-diagram-derived optimal value as presented within this work. The proposed multi-parameter cutoff-index diagram includes novel index cutoff AOX. It is a new different method that allows a quantitative comparison of the results from multi-parameter ROC curves, which cannot be performed with the AUC. However, the methods are different and do not exclude each other. Full article

The quantitative analysis of nucleic acid markers is extensively utilized in cancer detection. However, it faces significant challenges, such as the need for specialized detection devices and the inherent complexity of testing procedures. To address these issues, this study proposes a simplified, rapid, and user-friendly platform for cancer nucleic acid marker detection. We firstly designed a polydimethylsiloxane (PDMS) device for the isothermal amplification reaction of nucleic acid biomarkers based on reverse-transcription recombinase-aided amplification (RT-RAA) technology. Specifically, three potential cancer nucleic acid biomarkers, carcinoembryonic antigen (CEA), prostate-specific antigen (PSA), and prostate cancer antigen 3 (PCA3) were amplified from human serum or urine samples in the PDMS device at body temperature. The reaction chamber was directly integrated with nucleic acid test strips labeled with colloidal gold nanoparticles, allowing for the visual observation of the detection results for the amplification products. The optimal reaction conditions, such as pH, reaction time, antibody, and streptavidin concentration, were defined after a series of optimization studies. The findings demonstrated that the optimal RT-RAA reaction time was 20 min, the primary antibodies were labeled with colloidal gold to the greatest extent at pH 8.5, and the optimal concentrations of secondary antibody and streptavidin were 1.0 mg/mL and 0.5 mg/mL, respectively. Furthermore, this novel detection approach could not only exhibit excellent sensitivity and specificity but also show high accuracy for the analysis of nucleic acid biomarkers in both clinical serum and urine samples. Therefore, the simplified and more convenient operation platform provides a new insight for the semi-quantitative analysis of cancer nucleic acid biomarkers and the rapid screening of early cancer, thereby offering a promising alternative to oncological point-of-care testing (POCT) diagnostics. Full article

Background: Point-of-care (POC) diagnostics is an innovative approach to healthcare analysis that brings the diagnostic process closer to the patient’s immediate care setting. This study was conducted to assess POC testing devices’ use in diagnosing cancer and detecting the main challenges facing laboratory specialists. Method: A cross-sectional study was conducted on conveniently selected laboratory specialists working in the Prince Mohammed bin Abdulaziz Hospital in Riyadh for six weeks. Result: A total of 187 study participants (51% males and 49% females) were enrolled. Around one-half of them (96, 51%) were less than 30 years old, and 85% had 1–5 years of experience, with 61% (124) having no previous cancer diagnosis devices training. Most of this study’s cohort was using ABL 90 Radio meter/blood gases (45, 24%), followed by ABL 800 Radio meter/blood gases (39, 20.9%), as the main cancer diagnostic devices. Several challenges were faced by this study’s participants during their work with cancer diagnosis devices. The participants shared that some time was needed to use most of the devices, and learning how to use them was a significantly steep learning curve (2.99 ± 0.07 of participants). Most participants (113, 60.4%) carried out all the control testing, and their results were compared completely (100%) with the central laboratory. They took special precautions to keep the instruments safe (162, 86.6%). Conclusion: The correlation between type of devices used and the challenges faced during the use of POCT cancer diagnosis devices showed that there is a significant correlation between all challenges facing the participants and the type of devices (p = 0.001), except for the need for time to use these devices (p = 0.53). There are many challenges facing workers who operate point-of-care cancer diagnosis devices to a high degree. Full article

Background: Increased demand of the serological biomarker test (GastroPanel^®) in non-invasive diagnosis of gastric cancer (GC) risk conditions, i.e., atrophic gastritis (AG) and Helicobacter pylori (Hp) infection, prompted the design of GastroPanel^® Quick test (GPQT) (Biohit Oyj, Helsinki, Finland) for point-of-care (POC) settings. Objective: This study validated the diagnostic accuracy (DA) of GPQT in diagnosis of AG and Hp among gastroscopy referral patients. Methods: Altogether, 266 patients were enrolled among the consecutive gastroscopy referrals at the Department of Gastroenterology, Fortis Hospital (Punjab, India). All patients underwent gastroscopy with biopsies (n = 249) classified using the Updated Sydney System (USS) and finger prick blood sampling for GPQT testing. Results: Biopsy-confirmed AG was found in 15.3% (38/249) of the patients. The overall agreement between the GPQT and the USS classification was 71.4% (95% CI 65.4–77.0%), with the weighted kappa (κ_w) of 0.823 (95% CI 0.773–0.862). In ROC analysis for moderate/severe AG of the corpus (AGC) endpoint, AUC = 0.990 (95% CI 0.979–1.000) and AUC = 0.971 (95% CI 0.948–0.995) for PGI and PGI/PGII, respectively. Hp IgG Ab test detected biopsy-confirmed Hp with AUC = 0.836 (95% CI 0.783–0.889). Conclusions: The GPQT favourably competes in accuracy with the ELISA test version (unified-GP) in diagnosis of AG and Hp in patients referred for diagnostic gastroscopy. Full article

Hepatitis C virus (HCV), a member of the Flaviviridae family, is an RNA virus enclosed in an envelope that infects approximately 50 million people worldwide. Despite its significant burden on public health, no vaccine is currently available, and many individuals remain unaware of their infection due to the often asymptomatic nature of the disease. Early detection of HCV is critical for initiating curative treatments, which can prevent long-term complications such as cirrhosis, liver cancer, and decompensated liver disease. However, conventional diagnostic approaches available, such as enzyme immunoassays (EIAs) and polymerase chain reaction (PCR)-based methods, are often costly, time-intensive, and challenging to be implemented in resource-limited settings. This review provides an overview of HCV disease and the structural components of the virus, illustrating how different diagnostic methods target various parts of the viral structure. It examines current diagnostic tests and assays, highlighting their mechanisms, applications, and limitations, which necessitates the development of improved detection methods. Additionally, the paper explores emerging technologies in HCV detection that could offer affordable, accessible, and easy-to-use diagnostic solutions, particularly for deployment in low-resource and point-of-care settings. These advancements have the potential to contribute significantly to achieving the World Health Organization’s (WHO) target of eliminating HCV as a public threat by 2030. Full article

Background: Muscle quality and mass in cancer patients have prognostic and diagnostic importance. Objectives: The objectives are to analyze agreement between gold-standard and bedside techniques for morphofunctional assessment. Methods: This cross-sectional study included 156 consecutive colorectal cancer outpatients that underwent computed tomography (CT) scanning at lumbar level 3 (L3), whole-body bioelectrical impedance analysis (BIA), point-of-care nutritional ultrasound^® (US), anthropometry, and handgrip strength in the same day. Measured muscle biomarkers were stratified by sex, age, BMI-defined obesity, and malnutrition using Global Leadership in Malnutrition (GLIM) criteria. Whole-body estimations for muscle mass (MM) and fat-free mass were calculated using two different equations in CT (i.e., Shen, and Mourtzakis) and four different equations for BIA (i.e., Janssen, Talluri, Kanellakis, and Kotler). Muscle cross-sectional area at L3 was estimated using the USVALID equation in US. Different cut-off points for muscle atrophy and myosteatosis were applied. Sarcopenia was defined as muscle atrophy plus dynapenia. Intra-technique and inter-technique agreement were analyzed with Pearson, Lin (ρ), and Cohen (k) coefficients, Bland–Altman analyses, and hypothesis tests for measures of central tendency. Results: Intra-technique agreements on muscular atrophy (CT k = 0.134, BIA k = −0.037, US k = 0.127) and myosteatosis (CT k = 0.122) were low, but intra-technique agreement on sarcopenia in CT was fair (k = 0.394). Inter-technique agreement on muscular atrophy and sarcopenia were low. Neither CT and BIA (ρ = 0.468 to 0.772 depending on equation), nor CT and US (ρ = 0.642), were interchangeable. Amongst the BIA equations, MM by Janssen proved the best, with a 1.5 (3.6) kg bias, (−5.6, 8.6) kg LoA, and 9/156 (5.7%) measurements outside the LoA. Muscle biomarkers in all techniques were worse in aged, female, or malnourished participants. Obesity was associated with higher muscle mass or surface biomarkers in all techniques. Conclusions: Bedside techniques adequately detected patterns in skeletal muscle biomarkers, but lacked agreement with a reference technique in the study sample using the current methodology. Full article

A novel approach to developing lateral flow assays (LFAs) for the detection of CYFRA 21-1 (cytokeratin 19 fragment, a molecular biomarker for epithelial-origin cancers) is proposed. Magnetic bioconjugates (MBCs) were employed in combination with advanced optical and magnetic tools to optimize assay conditions. The approach integrates such techniques as label-free spectral-phase interferometry, colorimetric detection, and ultrasensitive magnetometry using the magnetic particle quantification (MPQ) technique. For the first time in LFA applications, the MPQ-based and colorimetry-based detection methods were compared side by side, and superior analytical performance was demonstrated. The limit of detection (LOD) of 0.9 pg/mL was achieved using MPQ, and 2.9 pg/mL with optical detection. This study has demonstrated that MPQ provides elimination of signal saturation, higher sensitivity (slope of the calibration curve), and a 19-fold wider dynamic range of detected signals. Both optical and magnetic detection results are comparable to the best laboratory-based tests with the added benefits of a 20-min assay duration and the LFA format convenience. The assay effectiveness was validated in human serum and artificial saliva, and high recovery rates were observed. The proposed approach offers rapid and reliable detection of molecular biomarkers and holds significant potential for point-of-care diagnostics, particularly in resource-limited settings. Full article

Liquid biopsy is an efficient diagnostic/prognostic tool for tumor-derived component detection in peripheral circulation and other body fluids. The rapid assessment of liquid biopsy techniques facilitates early cancer diagnosis and prognosis. Early and precise detection of tumor biomarkers provides crucial information about the tumor that guides clinicians towards effective personalized medicine. Point-of-care-testing remains still a great challenge in cancer diagnostics. Liquid biopsy is a promising alternative to tissue biopsy with the great advantages of less invasion and real-time monitoring of the disease, also providing information about tumor heterogeneity. The field is continuously and rapidly expanding. Numerous sophisticated biosensors have been developed targeting several biomarkers to achieve low detection limits, increased specificity and robustness. Current biosensors include mainly optical sensors, such as colorimetric, fluorescent, SPR, SERS and lateral flow assays. Electrochemical sensors have also been developed, providing very low detection limits. Colorimetric sensors exhibited simplicity in signal interpretation, while fluorescent sensors contributed to low analysis times, and SPR/SERS enabled label-free and rapid analysis. Novel target amplification and signal enhancement techniques have been exploited to increase the detectability of the sensors. In this context, this review is focused on the recent advances in biosensing technology for cutting-edge liquid biopsy applications towards point-of-care testing. Full article

Human Papillomavirus (HPV) infection is a significant global health concern linked to various cancers, particularly cervical cancer. Timely and accurate detection of HPV is crucial for effective management and prevention strategies. Traditional laboratory-based HPV testing methods often suffer from limitations such as long turnaround times, restricted accessibility, and the need for trained personnel, especially in resource-limited settings. Consequently, there is a growing demand for point-of-care (POC) HPV testing solutions that offer rapid, easy-to-use, and convenient screening at the primary care level. This review provides a comprehensive overview of recent advancements and emerging technologies utilized in POC HPV testing using isothermal amplification methods, in addition to evaluating their diagnostic performance, sensitivity, specificity, and clinical utility compared to conventional laboratory-based assays, particularly in low-resource settings, where access to centralized laboratory facilities is limited. We provide insights into the potential of isothermal nucleic acid amplification to revolutionize cervical cancer screening and prevention efforts worldwide, with emphasis on the need for continued research, innovation, and collaboration to optimize the performance, accessibility, and affordability of POC HPV testing solutions, ultimately contributing to the worldwide effort towards the elimination of this disease. Full article