The potential of paper-based diagnostics to meet the ASSURED criteria

Smith, Suzanne; Korvink, Jan G.; Mager, Dario; Land, Kevin

doi:10.1039/c8ra06132g

Cited by 109 publications

(75 citation statements)

References 189 publications

(259 reference statements)

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“…Two main sections were defined on the basis of the different component integration strategies, that is devices with the electrochemical transducers and the fluidic structures fabricated Such a number of works have also resulted in many review articles published during the last five years. Good examples are one that focused on nanoparticle-based lateral flow biosensors that was published in 2015 [2] and three mainly focused on biomedical diagnostic applications that were published in 2017 [3,4] and 2018 [5]. In these reviews, different detection techniques were discussed, mainly optical transduction approaches.…”

Section: Introductionmentioning

confidence: 99%

Electrochemical Paper-Based Biosensor Devices for Rapid Detection of Biomarkers

Gutiérrez-Capitán

Baldi

Fernández‐Sánchez

2020

Sensors

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In healthcare, new diagnostic tools that help in the diagnosis, prognosis, and monitoring of diseases rapidly and accurately are in high demand. For in-situ measurement of disease or infection biomarkers, point-of-care devices provide a dramatic speed advantage over conventional techniques, thus aiding clinicians in decision-making. During the last decade, paper-based analytical devices, combining paper substrates and electrochemical detection components, have emerged as important point-of-need diagnostic tools. This review highlights significant works on this topic over the last five years, from 2015 to 2019. The most relevant articles published in 2018 and 2019 are examined in detail, focusing on device fabrication techniques and materials applied to the production of paper fluidic and electrochemical cell architectures as well as on the final device assembly. Two main approaches were identified, that are, on one hand, those ones where the fabrication of the electrochemical cell is done on the paper substrate, where the fluidic structures are also defined, and, on the other hand, the fabrication of those ones where the electrochemical cell and liquid-driving paper component are defined on different substrates and then heterogeneously assembled. The main limitations of the current technologies are outlined and an outlook on the current technology status and future prospects is given.

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Section: Introductionmentioning

confidence: 99%

Electrochemical Paper-Based Biosensor Devices for Rapid Detection of Biomarkers

Gutiérrez-Capitán

Baldi

Fernández‐Sánchez

2020

Sensors

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“…Paper-based lateral flow assays (LFAs), also known as Rapid Diagnostic Tests (RDTs), are appealing for POC serological analysis due to their low-cost, ease-of-use, and rapid nature [25][26][27] . These tests use e.g., colorimetric or fluorescent conjugates embedded in one-time-use cassettes to rapidly and cost-effectively detect the presence of antibodies specific to disease.…”

Section: Introductionmentioning

confidence: 99%

Point-of-care serodiagnostic test for early-stage Lyme disease using a multiplexed paper-based immunoassay and machine learning

Joung

Ballard

et al. 2019

Preprint

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Caused by the tick-borne spirochete, Borrelia burgdorferi, Lyme disease (LD) is the most common vector-borne infectious disease in North America and Europe. Though timely diagnosis and treatment are effective in preventing disease progression, current tests are insensitive in early-stage LD, with a sensitivity <50%. Additionally, the serological testing currently recommended by the US Center for Disease Control has high costs (>$400/test) and extended sample-to-answer timelines (>24 hours). To address these challenges, we created a cost-effective and rapid point-of-care (POC) test for early-stage LD that assays for antibodies specific to seven Borrelia antigens and a synthetic peptide in a paper-based multiplexed vertical flow assay (xVFA). We trained a deep learning-based diagnostic algorithm to select an optimal subset of antigen/peptide targets, and then blindly-tested our xVFA using human samples (N(+) = 42, N(-)= 54), achieving an area-under-the-curve (AUC), sensitivity, and specificity of 0.950, 90.5%, and 87.0% respectively, outperforming previous LD POC tests. With batch-specific standardization and threshold tuning, the specificity of our blind-testing performance improved to 96.3%, with an AUC and sensitivity of 0.963 and 85.7%, respectively.

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“…Due to their low-cost materials, compact designs, and requirement for rapid and user-friendly operation, POC tests are often less accurate when compared to traditional laboratory tests and assays [7][8][9][10][11][12] . For example, paper-based immuno-assays such as rapid diagnostic tests (RDTs) offer an affordable and user-friendly class of POC tests which have been developed for malaria, HIV-1/2, and cancer screening, among other uses [13][14][15][16][17] . However, these RDTs lack the sensitivity and specificity needed for certain diagnostic applications largely due to issues of reagent stability, fabrication and operational variability, as well as matrix effects present in complex samples such as blood 15,16,18 .…”

Section: Introductionmentioning

confidence: 99%

“…For example, paper-based immuno-assays such as rapid diagnostic tests (RDTs) offer an affordable and user-friendly class of POC tests which have been developed for malaria, HIV-1/2, and cancer screening, among other uses [13][14][15][16][17] . However, these RDTs lack the sensitivity and specificity needed for certain diagnostic applications largely due to issues of reagent stability, fabrication and operational variability, as well as matrix effects present in complex samples such as blood 15,16,18 . Additionally, a well-known competitive binding phenomenon called the hook-effect can lead to false reporting of results, specifically in instances where the sensing analyte can be present over a large dynamic range [19][20][21][22][23][24] .…”

Section: Introductionmentioning

confidence: 99%

Deep Learning-Enabled Point-of-Care Sensing Using Multiplexed Paper-Based Sensors

Ballard

Joung²,

Goncharov³

et al. 2019

Preprint

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ABSTRACTWe present a deep learning-based framework to design and quantify point-of-care sensors. As its proof-of-concept and use-case, we demonstrated a low-cost and rapid paper-based vertical flow assay (VFA) for high sensitivity C-Reactive Protein (hsCRP) testing, a common medical test used for quantifying the degree of inflammation in patients at risk of cardio-vascular disease (CVD). A machine learning-based sensor design framework was developed for two key tasks: (1) to determine an optimal configuration of immunoreaction spots and conditions, spatially-multiplexed on a paper-based sensing membrane, and (2) to accurately infer the target analyte concentration based on the signals of the optimal VFA configuration. Using a custom-designed mobile-phone based VFA reader, a clinical study was performed with 85 human serum samples to characterize the quantification accuracy around the clinically defined cutoffs for CVD risk stratification. Results from blindly-tested VFAs indicate a competitive coefficient of variation of 11.2% with a linearity of R2 = 0.95; in addition to the success in the high-sensitivity CRP range (i.e., 0-10 mg/L), our results further demonstrate a mitigation of the hook-effect at higher CRP concentrations due to the incorporation of antigen capture spots within the multiplexed sensing membrane of the VFA. This paper-based computational VFA that is powered by deep learning could expand access to CVD health screening, and the presented machine learning-enabled sensing framework can be broadly used to design cost-effective and mobile sensors for various point-of-care diagnostics applications.

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The potential of paper-based diagnostics to meet the ASSURED criteria

Abstract: A review of printed functionalities towards integrated paper-based diagnostics that fully meet the ASSURED principles.

Cited by 109 publications

References 189 publications

Electrochemical Paper-Based Biosensor Devices for Rapid Detection of Biomarkers

Electrochemical Paper-Based Biosensor Devices for Rapid Detection of Biomarkers

Point-of-care serodiagnostic test for early-stage Lyme disease using a multiplexed paper-based immunoassay and machine learning

Deep Learning-Enabled Point-of-Care Sensing Using Multiplexed Paper-Based Sensors

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