Paper-based immunoassay based on 96-well wax-printed paper plate combined with magnetic beads and colorimetric smartphone-assisted measure for reliable detection of SARS-CoV-2 in saliva

Fabiani, Laura; Mazzaracchio, Vincenzo; Moscone, Danila; Fillo, Silvia; Santis, Riccardo De; Monte, Anella; Amatore, Donatella; Lista, Florigio; Arduini, Fabiana

doi:10.1016/j.bios.2021.113909

Cited by 36 publications

(33 citation statements)

References 39 publications

(41 reference statements)

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“…The linear range of this product for detecting SARS‐CoV‐2 in saliva is 0.1 μg/ml −10 . The consistency between the detection results and real‐time fluorescence quantitative PCR was 100% 57 . SARS‐CoV‐2 S1 spike protein antibodies immobilized on graphene material can capture 60 copies/mL of the virus by electrical transduction in midturbinate swabs and exhaled breath aerosol samples 58 .…”

Section: Introductionmentioning

confidence: 80%

“…The color can be read on a 96‐hole stencil board with a Spotxel free‐charge app on a smartphone to interpret the result. 57 The linear range of this product for detecting SARS‐CoV‐2 in saliva is 0.1 μg/ml −10 . The consistency between the detection results and real‐time fluorescence quantitative PCR was 100%.…”

Section: Introductionmentioning

confidence: 99%

“…The consistency between the detection results and real‐time fluorescence quantitative PCR was 100%. 57 SARS‐CoV‐2 S1 spike protein antibodies immobilized on graphene material can capture 60 copies/mL of the virus by electrical transduction in midturbinate swabs and exhaled breath aerosol samples. 58 The B.1.1.7 mutant can be detected at 400–8000 copies/ml of the virus.…”

Section: Introductionmentioning

confidence: 99%

“…Laura Fabiani et al developed a novel paper‐based immunoassay using magnetic beads to support the immunological chain. The color can be read on a 96‐hole stencil board with a Spotxel free‐charge app on a smartphone to interpret the result 57 . The linear range of this product for detecting SARS‐CoV‐2 in saliva is 0.1 μg/ml −10 .…”

Section: Introductionmentioning

confidence: 99%

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Performance and application evaluation of SARS‐CoV‐2 antigen assay

Shao

Meng

2022

Journal of Medical Virology

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Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) nucleic acid detection is the gold standard for the laboratory diagnosis of coronavirus disease 2019 (COVID‐19). However, this method has high requirements for practitioners' skills and testing sites, so it is not easy to popularize and promote the application in places other than large hospitals. In addition, the detection flux of SARS‐CoV‐2 nucleic acid is small, and the whole detection process takes much time, which cannot meet the actual needs of rapid screening in large quantities. The WHO conditionally approved a batch of SARS‐CoV‐2 antigen reagents for clinical application to alleviate this contradiction. SARS‐CoV‐2 antigen detection offers a trade‐off among clinical performance, speed and accessibility. With the gradual increase in clinical application, the accumulated clinical data show that the sensitivity and specificity of the SARS‐CoV‐2 antigen assay are over 80% and 97%, respectively, which can basically meet the requirements of the WHO. However, the sensitivity of the SARS‐CoV‐2 Antigen Assay among asymptomatic people in low prevalence areas of COVID‐19 cannot meet the standard, leading to a large number of missed diagnoses. In addition, the detection ability of SARS‐CoV‐2 antigen reagent for different SARS‐CoV‐2 mutant strains differs greatly, especially for those escaping the COVID‐19 vaccines. In terms of results interpretation, it is highly reliable to exclude SARS‐CoV‐2 infection based on the high negative predictive value of the SARS‐CoV‐2 antigen assay. However, in the low prevalence environment, the probability of false positives of the SARS‐CoV‐2 antigen assay is high, so the positive results need to be confirmed by the SARS‐CoV‐2 nucleic acid reagent. The SARS‐CoV‐2 antigen assay is only a supplement to SARS‐CoV‐2 nucleic acid detection and can never completely replace it. To date, SARS‐CoV‐2 nucleic acid detection continues to be the standard laboratory method for COVID‐19 diagnosis.

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Section: Introductionmentioning

confidence: 80%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Performance and application evaluation of SARS‐CoV‐2 antigen assay

Shao

Meng

2022

Journal of Medical Virology

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“…This method is simple, fast, and label-free, but lacks selectivity and specificity, in addition to the interference of complex system has non-negligible influence. Due to its good magnetic responsiveness and strong maneuverability ( Fabiani et al, 2022 ; Sui et al, 2020 ; Wang et al, 2021c ), the introduction of magnetic beads (MBs) is expected to achieve efficient target capture and separation in complex systems without sample pre-processing, effectively simplifying operations, saving time, and eliminating interference. 2) Indirect detection is achieved by using marking and recognition components.…”

Section: Introductionmentioning

confidence: 99%

A general controllable release amplification strategy of liposomes for single-particle collision electrochemical biosensing

Liu

Shi

et al. 2022

Biosensors and Bioelectronics

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A 3D paper microfluidic device for enzyme‐linked assays: Application to DNA analysis

Toldrà

Chondrogiannis

Hamedi

2023

Biotechnology Journal

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A paper microfluidic device capable of conducting enzyme‐linked assays is presented: a microfluidic enzyme‐linked paper analytical device (μEL‐PAD). The system exploits a wash‐free sandwich coupling to form beads/analyte/enzyme complexes, which are subsequently added to the vertical flow device composed of wax‐printed paper, waxed nitrocellulose membrane and absorbent/barrier layers. The nitrocellulose retains the bead complexes without disrupting the flow, enabling for an efficient washing step. The entrapped complexes then interact with the chromogenic substrate stored on the detection paper, generating a color change on it, quantified with an open‐source smartphone software. This is a universal paper‐based technology suitable for high‐sensitivity quantification of many analytes, such as proteins or nucleic acids, with different enzyme‐linked formats. Here, the potential of the μEL‐PAD is demonstrated to detect DNA from Staphylococcus epidermidis. After generation of isothermally amplified genomic DNA from bacteria, Biotin/FITC‐labeled products were analyzed with the μEL‐PAD, exploiting streptavidin‐coated beads and antiFITC‐horseradish peroxidase. The μEL‐PAD achieved a limit of detection (LOD) and quantification <10 genome copies/μL, these being at least 70‐ and 1000‐fold lower, respectively, than a traditional lateral flow assay (LFA) exploiting immobilized streptavidin and antiFITC‐gold nanoparticles. It is envisaged that the device will be a good option for low‐cost, simple, quantitative, and sensitive paper‐based point‐of‐care testing.

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Paper-based immunoassay based on 96-well wax-printed paper plate combined with magnetic beads and colorimetric smartphone-assisted measure for reliable detection of SARS-CoV-2 in saliva

Cited by 36 publications

References 39 publications

Performance and application evaluation of SARS‐CoV‐2 antigen assay

Performance and application evaluation of SARS‐CoV‐2 antigen assay

A general controllable release amplification strategy of liposomes for single-particle collision electrochemical biosensing

A 3D paper microfluidic device for enzyme‐linked assays: Application to DNA analysis

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