scholarly journals Open-source, Adaptable, All-in-one Smartphone-based System for Quantitative Analysis of Point-of-care Diagnostics.

Author(s):  
Weronika Schary ◽  
Filip Paskali ◽  
Simone Rentschler ◽  
Christoph Ruppert ◽  
Gabriel Wagner ◽  
...  

Abstract Point-of-care (POC) diagnostics, in particular lateral flow assays (LFA), represent a great opportunity for rapid, precise, low-cost and accessible diagnosis of disease. Especially with the ongoing coronavirus disease 2019 (COVID-19) pandemic, rapid point-of-care tests are becoming everyday tools for identification and prevention. Using smartphones as biosensors can enhance POC devices as portable, low-cost POC platforms for healthcare and medicine, food and environmental monitoring, improving diagnosis and documentation in remote, low-income locations. We present an open-source, all-in-one smartphone-based system for quantitative analysis of LFAs. It consists of a 3D-printed photo box, a smartphone for image acquisition, and an R Shiny software package with modular, customizable analysis workflow for image editing, analysis, data extraction, calibration and quantification of the assays. This system is less expensive than commonly used hardware and software, so it could prove very beneficial for diagnostic testing in the context of pandemics, as well as in low-resource countries.

Author(s):  
Antonia Perju ◽  
Nongnoot Wongkaew

AbstractLateral flow assays (LFAs) are the best-performing and best-known point-of-care tests worldwide. Over the last decade, they have experienced an increasing interest by researchers towards improving their analytical performance while maintaining their robust assay platform. Commercially, visual and optical detection strategies dominate, but it is especially the research on integrating electrochemical (EC) approaches that may have a chance to significantly improve an LFA’s performance that is needed in order to detect analytes reliably at lower concentrations than currently possible. In fact, EC-LFAs offer advantages in terms of quantitative determination, low-cost, high sensitivity, and even simple, label-free strategies. Here, the various configurations of EC-LFAs published are summarized and critically evaluated. In short, most of them rely on applying conventional transducers, e.g., screen-printed electrode, to ensure reliability of the assay, and additional advances are afforded by the beneficial features of nanomaterials. It is predicted that these will be further implemented in EC-LFAs as high-performance transducers. Considering the low cost of point-of-care devices, it becomes even more important to also identify strategies that efficiently integrate nanomaterials into EC-LFAs in a high-throughput manner while maintaining their favorable analytical performance.


Micromachines ◽  
2021 ◽  
Vol 12 (12) ◽  
pp. 1464
Author(s):  
Florina Silvia Iliescu ◽  
Ana Maria Ionescu ◽  
Larisa Gogianu ◽  
Monica Simion ◽  
Violeta Dediu ◽  
...  

The deleterious effects of the coronavirus disease 2019 (COVID-19) pandemic urged the development of diagnostic tools to manage the spread of disease. Currently, the “gold standard” involves the use of quantitative real-time polymerase chain reaction (qRT-PCR) for SARS-CoV-2 detection. Even though it is sensitive, specific and applicable for large batches of samples, qRT-PCR is labour-intensive, time-consuming, requires trained personnel and is not available in remote settings. This review summarizes and compares the available strategies for COVID-19: serological testing, Point-of-Care Testing, nanotechnology-based approaches and biosensors. Last but not least, we address the advantages and limitations of these methods as well as perspectives in COVID-19 diagnostics. The effort is constantly focused on understanding the quickly changing landscape of available diagnostic testing of COVID-19 at the clinical levels and introducing reliable and rapid screening point of care testing. The last approach is key to aid the clinical decision-making process for infection control, enhancing an appropriate treatment strategy and prompt isolation of asymptomatic/mild cases. As a viable alternative, Point-of-Care Testing (POCT) is typically low-cost and user-friendly, hence harbouring tremendous potential for rapid COVID-19 diagnosis.


2018 ◽  
Vol 941 ◽  
pp. 2522-2527
Author(s):  
Sylvio Schneider ◽  
Martina Selig ◽  
Verena Keil ◽  
Matthias Lehmann ◽  
Andreas H. Foitzik ◽  
...  

Smartphones are developing into all-purposes devices. In the present work, the employment/application of smartphones as medical devices in home care and point-of-care (POC) diagnostics are investigated in the analysis of Lateral Flow Assays (LFA). A smartphone-based LFA reader was developed for the quantitative analysis of D-Dimer – a biomarker indicating e.g. thrombotic event or danger of embolism.The proof-of-concept has been shown with multiple smartphones in establishing: (I) Optimal dimensions of the LFA cell of 72.11mm distance of smartphone to D-Dimer test leading to a coefficients of variances (CV) between 0.8% and 4.2%. (II) Inter-device investigations: CVs around 13.5%; a limit of detection (LOD) of 100ng/ml (DDU) D-Dimer. (III) Inter-smartphone investigations: CV about 16%, a limit of detection (LOD) at 66.4ng/ml (DDU). (IV) Calibrations: CV and LOD of three smartphones are comparable to the commercial available LFA reader. Further development to put the multiple smartphone-based LFA reader on the market.


2009 ◽  
Vol 11 (3) ◽  
pp. 280-287 ◽  
Author(s):  
Aurelia Macabasco-O'Connell ◽  
Sheba Meymandi ◽  
Robert Bryg

Low-income, uninsured individuals with multiple cardiovascular risk factors (CRFs) are at risk of heart failure (HF). B-type natriuretic peptide (BNP) screening for asymptomatic left ventricular dysfunction (ALVD) has not been tested specifically in this group. The purposes of this study were to describe BNP levels in asymptomatic low-income, uninsured individuals with multiple CRFs and determine the correlation between BNP levels and echocardiography for identifying ALVD. Methods: This correlational study included 53 patients (age 55 ± 10 years, 83% non-White, 64% female). BNP testing and echocardiogram (ECHO) were performed. Results: Of the 30 patients (57%) diagnosed with ALVD by ECHO, 21 (40%) had diastolic and 9 (17%) systolic dysfunction. BNP levels were lower among those with normal left ventricular (LV) function (29.6 ± 24 pg/mL) than those with diastolic (80.2 ± 69 pg/mL, p = .01) and systolic dysfunction (337.1 ± 374 pg/mL, p = .009). sParticipants with BNP ≥50 pg/ mL were 5.75 times more likely to exhibit diastolic dysfunction (odds ratio [OR] = 5.75, 95% confidence interval [CI] 1.29— 25.51; p < .01) and those with BNP ≥100 pg/mL were 7.80 times more likely to have systolic dysfunction (OR = 7.8, 95% CI 1.60—37.14; p < .005) than those with lower levels. With BNP cut point of 50 pg/mL, area under the curve (AUC) was 0.82 (95% CI 0.63—1.00) with sensitivity of 88% and specificity of 67%. Conclusion: BNP is a low-cost method to detect ALVD in high-risk, uninsured, low-income individuals. Elevated BNP levels should prompt initiation of further diagnostic testing and early treatment.


Polymers ◽  
2018 ◽  
Vol 10 (12) ◽  
pp. 1387 ◽  
Author(s):  
Chee Yew ◽  
Pedram Azari ◽  
Jane Choi ◽  
Farina Muhamad ◽  
Belinda Pingguan-Murphy

Electrospun polycaprolactone (PCL) nanofibers have emerged as a promising material in diverse biomedical applications due to their various favorable features. However, their application in the field of biosensors such as point-of-care lateral flow assays (LFA) has not been investigated. The present study demonstrates the use of electrospun PCL nanofibers as a reaction membrane for LFA. Electrospun PCL nanofibers were treated with NaOH solution for different concentrations and durations to achieve a desirable flow rate and optimum detection sensitivity in nucleic acid-based LFA. It was observed that the concentration of NaOH does not affect the physical properties of nanofibers, including average fiber diameter, average pore size and porosity. However, interestingly, a significant reduction of the water contact angle was observed due to the generation of hydroxyl and carboxyl groups on the nanofibers, which increased their hydrophilicity. The optimally treated nanofibers were able to detect synthetic Zika viral DNA (as a model analyte) sensitively with a detection limit of 0.5 nM. Collectively, the benefits such as low-cost of fabrication, ease of modification, porous nanofibrous structures and tunability of flow rate make PCL nanofibers a versatile alternative to nitrocellulose membrane in LFA applications. This material offers tremendous potential for a broad range of point-of-care applications.


Author(s):  
John P. Sibbitt ◽  
Mei He

Microfluidic lab-on-a-chip (MLOC) technology is a promising approach for point-of-care (POC) diagnosis; low reagent consumption, high sensitivity and quick analysis time are the most prominent benefits. However, microfabrication of MLOCs utilizes specialized techniques and infrastructure, making conventional fabrication time consuming and difficult. While relatively inexpensive production techniques exist for POC diagnoses, such as replication of polymer-based (e.g., PDMS) microfluidic POC devices on lithographic molds, this approach has limitations including: further hydrophilic surface modifications of PDMS, inability to change lithographic mold Z dimensions, and slow prototyping. In contrast, stereo-lithographical (SLA) printing can integrate all of the necessary fabrication resources in one instrument, allowing highly versatile microfluidic devices to be made at low cost. In this paper, we report two microfabrication approaches of microfluidics utilizing (SLA) 3D printing technology: I) Direct SLA printing of channels and structures of a monolithic microfluidic POC device; II) Indirect fabrication, utilizing SLA 3D printed molds for PDMS based microfluidic device replication. Additionally, we discuss previous work providing a proof of concept of applications in POC diagnosis, using direct 3D printing fabrication (approach I). The robustness and simplicity of these protocols allow integrating 3D design and microfabrication with smartphone-based disease diagnosis as a stand-alone system, offering strong adaptability for establishing diagnostic capacity in resource-limited areas and low-income countries.


2020 ◽  
Author(s):  
Susanna K. Elledge ◽  
Xin X. Zhou ◽  
James R. Byrnes ◽  
Alexander J. Martinko ◽  
Irene Lui ◽  
...  

Current serology tests for SARS-CoV-2 antibodies mainly take the form of enzyme-linked immunosorbent assays or lateral flow assays, with the former being laborious and the latter being expensive and often lacking sufficient sensitivity and scalability. Here we present the development and validation of a rapid, low-cost solution-based assay to detect antibodies in serum, plasma, whole blood, and saliva, using rationally designed split luciferase antibody biosensors (spLUC). This new assay, which generates quantitative results in as short as 5 minutes, substantially reduces the complexity and improves the scalability of COVID-19 antibody tests for point-of-care and broad population testing.


2021 ◽  
Vol 6 (1) ◽  
pp. 43
Author(s):  
Dimitrios Karadimas ◽  
George Tsekenis

The emergence of the novel coronavirus, SARS-CoV-2, has highlighted the need for rapid, accurate, and point-of-care diagnostic testing. Lab-on-a-Chip (LoC) devices offer the possibility to run such tests at a low cost, while at the same time permitting the multiplexed detection of several viruses when coupled with microarray detection of the amplified products. Herein, we report the development of a protocol for the qualitative detection of SARS-CoV-2, through the design of appropriate primers that target the evolutionary conserved regions of the virus. The proposed protocol relies on an improved version of asymmetric RT-PCR, the linear-after-the-exponential (LATE)-PCR that uses primers that are deliberately designed for use at unequal concentrations. As a result, LATE-PCR exhibits similar efficiency to symmetric PCR, while promoting accumulation of single-stranded products that can subsequently hybridize to a single-strand DNA probe-spotted microarray. The performance of the developed LATE-PCR protocol was compared to that of symmetric RT-PCR, and validated with the use of artificial viral RNA and nasopharyngeal swab samples from real patients. Furthermore, and in order to illustrate its potential for integration into a biosensor platform, the amplicons were allowed to hybridize with probes that were covalently immobilized onto commercially available functionalized glass, without the need for heat denaturation.


2018 ◽  
Vol 11 (1) ◽  
pp. 219-244 ◽  
Author(s):  
David Gasperino ◽  
Ted Baughman ◽  
Helen V. Hsieh ◽  
David Bell ◽  
Bernhard H. Weigl

The performance, field utility, and low cost of lateral flow assays (LFAs) have driven a tremendous shift in global health care practices by enabling diagnostic testing in previously unserved settings. This success has motivated the continued improvement of LFAs through increasingly sophisticated materials and reagents. However, our mechanistic understanding of the underlying processes that drive the informed design of these systems has not received commensurate attention. Here, we review the principles underpinning LFAs and the historical evolution of theory to predict their performance. As this theory is integrated into computational models and becomes testable, the criteria for quantifying performance and validating predictive power are critical. The integration of computational design with LFA development offers a promising and coherent framework to choose from an increasing number of novel materials, techniques, and reagents to deliver the low-cost, high-fidelity assays of the future.


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