State of the Art on the SARS-CoV-2 Toolkit for Antigen Detection: One Year Later
Abstract
:1. Introduction
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- CoNVat: Combating 2019-nCoV: Advanced Nanobiosensing platforms for POC global diagnostics and surveillance to develop a point-of-care device using optical biosensor technology for rapid diagnosis and monitoring of the new coronavirus directly in the patient’s sample (four partners: ES(2), FR, and IT) [8].
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- CORONADX: Three rapid diagnostic tests (point-of-care) for COVID-19 Coronavirus, improving epidemic preparedness, public health, and socioeconomic benefits to deliver three complementary diagnostic tools, including one point-of-care diagnostic that can be used with minimal training (eight partners: AT, CN(2), DK(2), IT(2), and SE) [9].
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- HG nCoV19 test: Development and validation of a rapid molecular diagnostic test for nCoV19 to develop and validate a novel rapid molecular diagnostic test for coronavirus (four partners: CN, IE, IT, and UK) [10].
2. SARS-CoV-2 Antigen Detection Using Nasopharyngeal Swab
3. SARS-CoV-2 Antigen Detection in Saliva
4. SARS-CoV-2 Antigen Detection in Serum
5. SARS-CoV-2 Antigen Detection in Droplets
6. Biosensors in the Literature vs. Commercialized Toolkits
7. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Antigen Swab Test | Sensitivity % | Specificity % | Limit of Detection (TCID50/mL) | Analysis Time (Min) | Ref. |
---|---|---|---|---|---|
STRONGSTEP | 96 | 99 | 2.50 × 102 | 15 | [18] |
BIOCREDIT | 90 | 90 | Not reported | 5–8 | [19] |
REALY TECH | 90 | 100 | 1.25 × 103 | 10–20 | [20] |
VIVADIAG | 83 | 100 | 1.35 × 103 | 15 | [21] |
ZKDENTAL | 87 | 100 | Not reported | 15 | [22] |
MOLAB | 99 | 98 | 1.15 × 102 | 15 | [23] |
JOYSBIO | 89 | 99 | 1.60 × 102 | 15 | [24] |
CLUNGENE | 91 | 100 | 5 × 102.67 | 15 | [25] |
Sample Matrix | Treatment | Ref. |
---|---|---|
Nasopharyngeal swab | Nasopharyngeal swabs were suspended in a universal transport medium | [26] |
Nasopharyngeal swab | Nasopharyngeal swabs were suspended in a viral transport medium | [32] |
Nasopharyngeal and throat swabs | Nasopharyngeal and throat swabs were mixed in a viral transport medium | [33] |
Nasopharyngeal swab | Not reported | [34] |
Nasopharyngeal swab | Nasopharyngeal specimens were vortexed in a universal transport medium | [35] |
Saliva | No treatment | [38] |
Saliva | No treatment | [39] |
Saliva | No treatment | [40] |
Saliva | No treatment | [41] |
Serum | Whole and 5× diluted | [43] |
Droplets | No treatment | [47] |
Analyte | Type of Biosensor | Type of Transduction | Matrix Analyzed | Linear Range (LR)/Detection Limit (LOD) | Time of Analysis | Ref. |
---|---|---|---|---|---|---|
S protein/virus | Graphene-based field-effect transistor immunosensor | FET | Nasopharyngeal swab | S protein LR: 0.1–100 pg/mL LOD: 100 fg/mL Virus: LR: 1.6 × 101–1.6 × 104 pfu/mL LOD: 1.6 × 101 pfu/mL | <1 min | [18] |
S/N protein | Single-walled carbon nanotube-based field-effect transistor immunosensor | FET | Nasopharyngeal swab | S protein LR: 5.5 fg/mL–5.5 pg/mL LOD: 0.55 fg/mL N protein LR: 16 fg/mL–16 pg/mL LOD: 0.016 fg/mL | <5 min | [24] |
N protein | Lateral-flow immunoassay | Colorimetric (visual) detection | Nasopharyngeal swab | sensitivity 98.33% | 15–30 min | [25] |
N protein/virus | Lateral-flow immunoassay based on scFv-Fc fusion proteins | Colorimetric detection | Nasopharyngeal swab | N protein LOD: 2 ng Virus LOD: 2.5 × 104 pfu | 20 min | [26] |
N protein | Molecularly imprinted polymer-based electrochemical sensor | Differential Pulse Voltammetry | Nasopharyngeal swab | LOD: 27 fM in clinical samples | 15 min | [27] |
S/N protein and virus | Magnetic bead-based immunosensor combined with carbon black-modified screen-printed electrode | Differential Pulse Voltammetry | Saliva | S protein LOD: 19 ng/mL in saliva N protein LOD: 8 ng/mL in saliva Virus: 6.5 pfu/mL concentration tested using S protein immunosensor and 6.5 × 103 pfu/mL concentration tested using N protein immunosensor | 30 min | [30] |
S/N protein | Magnetic bead-based sensor using a biotinylated aptamer-oligo-invertase complex | Glucometer | Saliva | N protein LOD: 5.27 pM in saliva S protein LOD: 6.31 pM in saliva | 60 min | [31] |
S protein/virus | A reagent-free electrochemical Sensor modified with an antibody attached to DNA linker functionalized with a ferrocene redox probe | Chronoamperometry | Saliva | S protein LOD: 1 pg/mL Virus LOD: 4000 copies per mL | 5 min/10 min | [32] |
N protein | An electrochemical immunosensing platform using laser-engraved graphene electrodes and a wireless transmission unit | Chronoamperometry | Saliva | LR: Up to 5000 pg/mL | 1 min | [33] |
N protein | Microfluidic immunosensor based on screen-printed gold electrode combined with magnetic nanobeads | Chronoamperometry | Serum | Whole serum LOD: 50 pg/mL 5× Diluted serum LOD: 10 pg/mL | Whole serum: 50 min 5× diluted serum: 25 min | [35] |
S protein/virus | Nanowire-based immunosensor combined with a miniaturized impedance circuit and a wireless transmission unit | Electrochemical impedance spectroscopy | Droplets | S protein in aerosol concentration tested: 1, 10 ng/mL Virus aerosol LOD: 7 pfu/mL corresponding to an air concentration of 0.35 pfu/L | S protein aerosol: 10 min Virus aerosol: 5 min | [39] |
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Fabiani, L.; Caratelli, V.; Fiore, L.; Scognamiglio, V.; Antonacci, A.; Fillo, S.; De Santis, R.; Monte, A.; Bortone, M.; Moscone, D.; et al. State of the Art on the SARS-CoV-2 Toolkit for Antigen Detection: One Year Later. Biosensors 2021, 11, 310. https://doi.org/10.3390/bios11090310
Fabiani L, Caratelli V, Fiore L, Scognamiglio V, Antonacci A, Fillo S, De Santis R, Monte A, Bortone M, Moscone D, et al. State of the Art on the SARS-CoV-2 Toolkit for Antigen Detection: One Year Later. Biosensors. 2021; 11(9):310. https://doi.org/10.3390/bios11090310
Chicago/Turabian StyleFabiani, Laura, Veronica Caratelli, Luca Fiore, Viviana Scognamiglio, Amina Antonacci, Silvia Fillo, Riccardo De Santis, Anella Monte, Manfredo Bortone, Danila Moscone, and et al. 2021. "State of the Art on the SARS-CoV-2 Toolkit for Antigen Detection: One Year Later" Biosensors 11, no. 9: 310. https://doi.org/10.3390/bios11090310