BC diagnosis relies on the insertion of an optical endoscope into the bladder cavity through urethra to image the suspected lesions. [7,8] This process is highly invasive and would cause urethra and bladder injury, resulting in hematuria and even urinary bacterial infection within a few days after examinations. [9] Critically, cystoscopy diagnosis is plagued with the inherent bladder tumor heterogeneity, and therefore, limits the accuracy of early BC diagnosis. [10] Recently, noninvasive liquid biopsy emerges as an alternative to address the bottleneck of spatiotemporal tumor heterogeneity and to obtain disease-relevant molecular information for clinical cancer diagnosis and cancer status monitoring. [11][12][13][14][15][16][17][18][19][20] Bladder is a urine storage organ that has been recognized as the metabolic microenvironment for bladder tumor cells, and its carcinogenesis and progression could make a pivotal impact on urine. [21] In this regard, the development of a urine biopsy provides a powerful strategy toward noninvasive early diagnosis and prognosis of BC. Clinically, urinalysis has been routinely utilized to detect abnormal metabolic biomarkers in urine for the assessment of health status and preliminary screening of diseases. [22][23][24][25] However, the physiologically relevant biomarkers detected by routine urinalysis are generally limited to high concentration targets over the micromolar level. On the other hand, the concentration Urinalysis is attractive in non-invasive early diagnosis of bladder cancer compared with clinical gold standard cystoscopy. However, the trace bladder tumor biomarkers in urine and the particularly complex urine environment pose significant challenges for urinalysis. Here, a clinically adoptable urinalysis device that integrates molecular-specificity indium gallium zinc oxide field-effect transistor (IGZO FET) biosensor arrays, a device control panel, and an internet terminal for directly analyzing five bladder-tumor-associated proteins in clinical urine samples, is reported for bladder cancer diagnosis and classification. The IGZO FET biosensors with engineered sensing interfaces provide high sensitivity and selectivity for identification of trace proteins in the complex urine environment. Integrating with a machine-learning algorithm, this device can identify bladder cancer with an accuracy of 95.0% in a cohort of 197 patients and 75 non-bladder cancer individuals, distinguishing cancer stages with an overall accuracy of 90.0% and assessing bladder cancer recurrence after surgical treatment. The non-invasive urinalysis device defines a robust technology for remote healthcare and personalized medicine.
Mass pathogen screening is critical to preventing the outbreaks and spread of infectious diseases. The largescale epidemic of COVID-19 and the rapid mutation of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus have put forward new requirements for virus detection and identification techniques. Here, we report a CRISPR-based Amplification-free Viral RNA Electrical Detection platform (CAVRED) for the rapid detection and identification of SARS-CoV-2 variants. A series of CRISPR RNA assays were designed to amplify the CRISPR-Cas system's ability to discriminate between mutant and wild RNA genomes with a single-nucleotide difference. The identified viral RNA information was converted into readable electrical signals through field-effect transistor biosensors for the achievement of highly sensitive detection of single-base mutations. CAVRED can detect the SARS-CoV-2 virus genome as low as 1 cp μL À 1 within 20 mins without amplification, and this value is comparable to the detection limit of real-time quantitative polymerase chain reaction. Based on the excellent RNA mutation detection ability, an 8-in-1 CAVRED array was constructed and realized the rapid identification of 40 simulated throat swab samples of SARS-CoV-2 variants with a 95.0 % accuracy. The advantages of accuracy, sensitivity, and fast speed of CAVRED promise its application in rapid and large-scale epidemic screening.
Comprehensive SummaryWith the advantages of high sensitivity, rapid response, label‐free, and simple operation, field effect transistor biosensors have shown promising application prospects in large‐scale pathogen screening. However, in practical biological fluids with relatively high ionic strength, such as saliva and serum, the Debye screening effect will weaken the interaction between FET biosensors and target bio‐molecules, thereby affecting the sensing sensitivity and accuracy. Herein, an interfacial polymer‐engineered field effect transistor (IPE FET) biosensor was developed for the efficient identification of SARS‐CoV‐2 N antigens in saliva samples. The inclusion of a polymer layer shortens the distance between target molecules and the electrode interface, which effectively overcomes the limitation of Debye screening. The constructed IPE FET biosensors exhibit high sensitivity and anti‐fouling capability, achieving efficient detection of SARS‐CoV‐2 N antigen in saliva within 5 min with a detection limit of 4.6 fg·mL−1. In a cohort of 35 simulated throat swab samples of SARS‐CoV‐2 N antigen, IPE FET exhibits an identification accuracy of up to 97.1%, with predictive sensitivity and specificity of 96.0% and 100.0%, respectively. The excellent performance of IPE FET not only provides a strategy to design efficient detection platforms but also suggests a pathway to realize rapid and scalable epidemic screening.
Nano-biosensors that are composed of recognition molecules and nanomaterials have been extensively utilized in disease diagnosis, health management, and environmental monitoring. As a type of nano-biosensors, molecular specificity field-effect transistor (FET) biosensors with signal amplification capability exhibit prominent advantages including fast response speed, ease of miniaturization, and integration, promising their high sensitivity for molecules detection and identification. With intrinsic characteristics of high stability and structural tunability, aptamer has become one of the most commonly applied biological recognition units in the FET sensing fields. This review summarizes the recent progress of FET biosensors based on aptamer functionalized nanomaterials in medical diagnosis and environmental monitoring. The structure, sensing principles, preparation methods, and functionalization strategies of aptamer modified FET biosensors were comprehensively summarized. The relationship between structure and sensing performance of FET biosensors was reviewed. Furthermore, the challenges and future perspectives of FET biosensors were also discussed, so as to provide support for the future development of efficient healthcare management and environmental monitoring devices.
Mass pathogen screening is critical to preventing the outbreaks and spread of infectious diseases. The largescale epidemic of COVID-19 and the rapid mutation of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus have put forward new requirements for virus detection and identification techniques. Here, we report a CRISPR-based Amplification-free Viral RNA Electrical Detection platform (CAVRED) for the rapid detection and identification of SARS-CoV-2 variants. A series of CRISPR RNA assays were designed to amplify the CRISPR-Cas system's ability to discriminate between mutant and wild RNA genomes with a single-nucleotide difference. The identified viral RNA information was converted into readable electrical signals through field-effect transistor biosensors for the achievement of highly sensitive detection of single-base mutations. CAVRED can detect the SARS-CoV-2 virus genome as low as 1 cp μL À 1 within 20 mins without amplification, and this value is comparable to the detection limit of real-time quantitative polymerase chain reaction. Based on the excellent RNA mutation detection ability, an 8-in-1 CAVRED array was constructed and realized the rapid identification of 40 simulated throat swab samples of SARS-CoV-2 variants with a 95.0 % accuracy. The advantages of accuracy, sensitivity, and fast speed of CAVRED promise its application in rapid and large-scale epidemic screening.
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