Innovation landscape in nanobiosensors for COVID-19 detection and future implications for a resilient Global Health Security.

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Learn more: PMC Disclaimer | PMC Copyright Notice 3 Biotech . 2025 May 15;15(6):170. doi: 10.1007/s13205-025-04342-1 Innovation landscape in nanobiosensors for COVID-19 detection and future implications for a resilient Global Health Security Abhijit Poddar 1, 2, ✉ , S R Rao 2 Author information Article notes Copyright and License information 1 Centre for Bio-Policy Research (CBPR), Mahatma Gandhi Medical Advanced Research Institute (MGMARI), Sri Balaji Vidyapeeth (Deemed-to-Be-University), Pondicherry, India 2 Genentech Regulatory Solutions LLP, Hyderabad, India ✉ Corresponding author. Received 2024 Sep 25; Accepted 2025 May 4; Issue date 2025 Jun. © King Abdulaziz City for Science and Technology 2025. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. PMC Copyright notice PMCID: PMC12081800  PMID: 40386630 Abstract This review presents a comprehensive analysis of nanobiosensors (NBSs) advancements for COVID-19 detection, highlighting their repurposing potential to enhance global health security against emerging threats. It outlines the use of various nanomaterials like gold and magnetic nanoparticles in developing NBSs for detecting SARS-CoV-2, emphasizing their adaptability and rapid detection capabilities. Gold nanoparticles are highlighted for their superior surface chemistries and stability, making them ideal for label-free COVID-19 detection and other diagnostic applications. Magnetic nanoparticles, particularly superparamagnetic iron oxides, offer alternative detection mechanisms based on magnetism, providing high sensitivity and reliability in pathogen detection. The document also discusses nonmetallic nanomaterials, such as single-walled carbon nanotubes and selenium nanoparticles, which have been used to develop optical and electrochemical NBSs for COVID-19 detection. Breathalyzers are recognized for their noninvasive, rapid detection of volatile organic compounds specific to COVID-19. Such advancements in NBSs have significantly contributed to global health security by providing reliable, portable, and affordable diagnostic solutions, especially in resource-limited settings. However, despite technological advancements, commercialization and market adoption challenges persist, necessitating improvements in manufacturing scalability, cost reduction, and clinical validation. The document emphasizes the need for transparent and efficient regulatory strategies to address concerns related to nanomaterial toxicity, health effects, and environmental impact during the R&D phase. While presenting a comprehensive framework for successful research to market translation, this review highlights the need for cross-sectoral collaboration to tailor country-specific nanotechnology roadmaps for optimized resource allocation, navigating diverse regulations, and addressing unique societal needs. Keywords: COVID-19 pandemic, Devices and diagnostics, Point of Care, Nanobiosensors, Nanotechnology, Global health security Introduction Nanobiosensors (NBSs) have significantly enhanced diagnostic capabilities in various sectors, such as healthcare, environmental monitoring, the food industry, and agriculture (Mohd et al. 2020 ). NBSs have been pivotal in developing innovative methods for pathogen surveillance and the detection of pathogen-derived molecules, including peptides, lipids, toxins, and DNA, within body fluids, serum, and even exhaled breath (Deng et al. 2021 ). Metallic and nonmetallic nanoparticles, nanobeads, nanocubes, and nanotubes fabricated different sensing platforms. These platforms are predominantly created through surface modifications of nanomaterials to incorporate biological probes such as antibodies and nucleic acids specific to the targeted molecules. Consequently, NBSs offer a simplified, rapid, highly sensitive, and Point of Care (PoC) pathogen detection capability, surpassing conventional diagnostic methods (Acharya and Singhal 2023 ). The COVID-19 pandemic, as a significant global health security threat, has propelled worldwide efforts towards pandemic preparedness and response. Globally, it has significantly increased scientific and technological endeavors, including a surge in research and development (R&D) activities, increased funding allocations, and international collaborations. In addition to vaccine discovery, the backbone of the pandemic response has been the timely detection of the SARS-CoV-2 virus (Oyewole et al. 2021 ). It facilitates identifying and isolating infected individuals to prevent further uncontrolled transmission. Extensive research and development resulted in novel diagnostic kits and devices (Mardian et al. 2021 ; Wei et al. 2023 ). The outcomes of these research and development activities have promptly translated into commercial value chains, witnessing long queues of multiple diagnostic kits and devices awaiting emergency use authorization from regulators. For example, The Central Drugs Standard Control Organization (CDSCO), India’s national regulatory authority for drugs, cosmetics, pharmaceuticals, and medical devices, had approved 262 COVID-19 testing PCR kits by mid-2022. Similarly, the US FDA approved around 270 RT-PCR kits till August 2023. Nucleic acid amplification tests, particularly RT-PCR, have been widely regarded as the gold standard for COVID-19 detection (Rabaan et al. 2021 ). Practically, RT-PCR has gained widespread recognition and has been the go-to solution for decision-making, especially in determining containment measures and travel restrictions. However, RT-PCR tests have exhibited limitations, including their inability to detect lower viral loads, lower sensitivity, the potential for false reporting, and more extended assessment and reporting times (Surkova et al. 2020 ; Dramé et al. 2020 ). Moreover, these tests do not support PoC diagnosis. It limits their utility in rapid biosurveillance, particularly in resource-poor nations with limited access to containment laboratories and human resources (Dhabaan et al. 2020 ; Mardian et al. 2021 ). Consequently, alternative and affordable diagnostic technologies have become necessary. Further, the COVID-19 pandemic and rapid mutations of viruses and other emerging health security threats have heightened the need for such innovations. The nanobiosensors (NBSs) based innovations in COVID-19 detection offer hope in meeting these demands. It is also driving the growth of the NBS-based diagnostic market, with a projected compound annual growth rate (CAGR) of 10%. By keeping the growing market dynamics and need for novel innovations for COVID-19, this review presents nanobiosensor (NBS) based diagnostics innovations. We reviewed the R&D innovations and a few commercialized detection devices. Finally, we look for the limitations by realizing the market disconnect of several interesting laboratory-based innovations, especially those that are low-cost, rapid, sensitive, and point-of-care. We made progressive recommendations for the rapid technology translation to strengthen global health security efforts. Gold nanoparticle-based nanobiosensors for COVID-19 detection Gold (Au) nanoparticles are the most versatile nanomaterial for fabricating NBS-based COVID-19 detection devices. Compared to other metallic nanoparticles, gold offers better surface chemistries (Mahato et al. 2019 ). It increases affinity toward sulfhydryl groups and strengthens bonds with thiol molecules. The gold-thiol nanoconjugates provide a better conjugative platform to harbor pathogen-detecting probes (Spampinato et al. 2016 ). Using such benefits, an Au-NBS was proposed for label-free detection of COVID-19 by Tripathi and Singh ( 2020 ). The authors recommended attaching thiol-modified complementary single-stranded probes against COVID-19 virus RNA and corresponding c-DNA on gold nanoparticles. The assembly was electrodeposited onto the titanium surface to develop the biosensing probe. In this case, gold offered stability, resistance against wash and chemical treatments, reproducibility, and accuracy. A biological sample containing COVID-19-specific nucleotides hybridized with the thiolate probe, resulting in a change in surface charge. The changes were proportional to the probe-target binding and captured using an appropriate electrochemical readout module placed below the nanomembrane. The overall construct and the detection device were portable. However, the need for sample processing before testing to obtain the complementary nucleotides for hybridization resulted in limited field-deplorability of the technology. Lima et al. ( 2021 ) developed an electrochemical advanced diagnostic (LEAD) test system for a more realistic PoC and do-it-yourself testing system (de Lima et al. 2021 ). It contained a low-cost graphite pencil electrode whose surface was modified with ACE2-coated Cys-functionalized AuNPs. In a sample containing SARS-CoV-2, the spike protein strongly binds with the ACE2 receptor on the electrode surface. The resultant electrochemical changes were detected using a redox probe. The system achieved 100% specificity and sensitivity while detecting the virus in saliva and above 85% sensitivity and specificity for nasopharyngeal/oropharyngeal sample testing. It produced results within 7 min with a limit of detection (LoD) as low as 229 fg of spike protein per mL of sample. Likewise, GenMark Diagnostics, Carlsbad, CA, developed and commercialized one GenMark ePlex SARS-CoV-2 diagnostic test that relied on electrochemical sensing (Zhen et al. 2021 ). The test used target-specific capture probes (targeting the N gene) bound to gold electrodes. The target DNA hybridizes with the capture probe and ferrocene-labeled signal probe. The company offers an eSensor technology platform that performs extraction, amplifies virus genes, and finally detects electrochemical changes. The results appeared within two hours, with a LoD of 750 genomic copies/mL. Colorimetric detection of COVID-19 was another method that used gold nanoparticle-based optical sensors. For example, Behrouzia and Lin ( 2022 ) developed antigen-coated gold nanoparticles that bind with the virus’s nucleocapsid (N) proteins (Behrouzi and Lin 2022 ). The binding resulted in the aggregation of nanoparticles that changed the distribution and resonance of electron clouds on gold nanosurfaces, a phenomenon referred to as localized surface plasmon or nanoplasmonic phenomena. Such changes are translated into higher optical absorptivity of aggregates and are visible through color changes. The authors reported a LoD as low as 150 ng/ml of N protein within 5 min of exposure. Peak optical absorption was recorded at 530 nm and had a linear relationship with concentrations of N protein in the sample. In the commercial sector, using this nanoplasmonic phenomenon, Nirmidas Biotech Inc. developed ELISA-based pGOLD™ COVID-19 IgG/IgM Assay Kits (Shaffaf and Ghafar-Zadeh 2021 ). The kit used gold nanoparticles with the S1 subunit of the spike protein, the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. The results are obtained within 2 h from clinical samples with a superior analytical sensitivity of approximately 5 logs of antibody concentrations with approximately 4–5 logs of signal dynamic range (Liu et al. 2020 ). In clinical settings, the kit offered > 87% sensitivity for IgM detection in patients 5 days after symptom onset and 100% sensitivity for both IgG and IgM 14 days after symptom onset. Multiple lateral flow assay (LFA) kits used the colorimetric virus detection method following gold nanosensor aggregation (Khan et al. 2022 ). Market adopted these kits because of the intrinsic benefits of LFAs, such as low cost, PoC, and readiness to self-interpret. Until 2022, the FDA approved 17 such kits that showed varying degrees of sensitivity and specificity (Table 1 ). Besides commercial sectors, Li et al. ( 2021 ) developed an LFA kit containing S1 protein-coated gold nanoparticles to self-assess COVID-19 vaccination efficacy (Li et al. 2021 ). It had a specificity of 99% and a LoD of 50 IU/mL for the pseudovirus-neutralizing titer. Likewise, Huang et al. ( 2020 ) used SARS-CoV-2 nucleoprotein (SARS-CoV-2 NP)-coated gold nanoparticles to develop a colloidal gold nanoparticle-based lateral-flow assay (Huang et al. 2020 ). It detected IgM from SARS-CoV-2-infected serum samples within 15 min with 100% sensitivity and 93.3% specificity. Table 1. FDA-approved nanobiosensors based LFA kit for the detection of COVID-19 Kit Name Manufacturer Highest Sensitivity Specificity Nanosensor specifications SGTi-flex COVID-19 IgG Sugentech Inc 98.6% (15 + dpos) 99.2% Recombinant SARS-CoV-2 Nucleocapsid and Spike RBD Protein conjugated to colloidal gold nanoparticles MidaSpot COVID-19 Antibody Combo Detection Kit Nirmidas Biotech, Inc 100% (15 + dpos) 100.00% antigen-coated gold colloidal particles RapCov Rapid COVID-19 Test ADVAITE, Inc 90.00% 95.20% SARS-CoV-2 antigen-conjugated gold colloid-coated particles ACON SARS-CoV-2 IgG/IgM Rapid Test ACON Laboratories, Inc 100% (0–7 dpos) 95.90% colloidal gold-labeled SARS-CoV-2 recombinant antigen Innovita 2019-nCoV Ab Test (Colloidal Gold) Innovita (Tangshan) Biological Technology Co., Ltd 100% (15 + dpos) 98.03% Recombinant SARS-CoV-2 antigen (S1 and NP proteins) and mouse IgG antibodies labeled with colloidal gold LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) Hangzhou Laihe Biotech Co., Ltd 100% (IgM, 0–6 dpos); 98.5% (IgG, 14 + dpos) 99.43% Colloidal gold-labeled recombinant COVID-19 S1 spike protein antigen Orawell IgM/IgG Rapid Test Jiangsu Well Biotech Co., Ltd 97.1% 100.0% Recombinant SARS-CoV-2 antigen(Receptorbindingdomain(RBD)of 2019nCoVSpike Protein) labeled with colloidal gold BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test Xiamen Biotime Biotechnology Co., Ltd 100% (14 + dpos) 99.23%% Colloidal gold-labeled SARS-CoV-2 recombinant antigen Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit Biohit Healthcare (Heifei) Co. Ltd 96.2% (IgG 15 + dpos), 97.7% (IgM 15 + dpos) 99.46% (IgM), 100% (IgG) colloidal gold-labeled SARS-CoV-2 recombinant antigen Assure COVID-19 IgG/IgM Rapid Test Device Assure Biotech (Hangzhou Co, Ltd.) 95% 100% SARS-CoV-2 antigen-conjugated gold colloid-coated particles TBG SARS-CoV-2 IgG/IgM Rapid Test Kit TBG Biotechnology Corp IgG: 96.4% IgM: 87.5% 99.8% SARS-CoV-2 recombinant antigens (S and N proteins) conjugated with colloidal gold (SARS-CoV-2 conjugates) and rabbit IgG-gold conjugates Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test Biocan Diagnostics Inc IgG: 93.3% IgM: 90% IgG: 96.2% IgM: 98.7% Recombinant COVID-19 antigen conjugated with colloid gold Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette Salofa Oy 100% 100% SARS-CoV-2 spike antigen conjugated gold colloid particles WANTAI SARS-CoV-2 Ab Rapid Test Beijing Wantai Biological Pharmacy Enterprise Co., Ltd 94.7% 98.9% Colloidal gold-labeled SARS-CoV-2 recombinant antigen RightSign COVID-19 IgG/IgM Rapid Test Cassette Hangzhou Biotest Biotech Co., Ltd 96.3% (igM 8–14 dpos); 96.2% (IgG 15 + dpos) 98.1% (IgM), 99.52% (IgG) SARS-CoV-2 antigen-conjugated gold colloid-coated particles COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Healgen Scientific LLC 96.7% 97% Colloidal gold conjugated to recombinant COVID-19 antigens (SARS-CoV-2 Spike S1 antigen) Open in a new tab Reference: JH Center for Health Security ( 2023 ) dpos days post onset of symptom Lateral flow assays have limitations, including hook effect and cross-contamination possibilities (Cavalera et al. 2022 ). Boumar et al. ( 2023 ) developed a novel hybrid flow assay (HFA) to detect COVID-19 without those limitations (Boumar et al. 2023 ). By combining the benefits of lateral and vertical flow assay methodologies, the HFA layer contained gold nanoparticles conjugated separately with S and N proteins. The layer was integrated into an adhesive bandage designed for application to the skin following a pinprick. Upon contact with blood containing IgG and IgM antibodies specific to the virus, the HFA generated a visible color change, confirming the presence of infection. Ferreira et al. ( 2021 ) developed a simple and rapid NBS-based colorimetric detection assay for COVID-19. The assay process was similar to the nasopharyngeal/oropharyngeal swab sample collection (Ferreira et al. 2021 ). The assay used a catch solution containing ACE2-coated Cys-functionalized AuNPs and cotton swabs containing ACE2. The cotton swab containing the virus produced a sandwich structure of (ACE2)-(SARS-CoV-2)-(AuNPs-Cys-ACE2) when placed in a catch solution. The plasmon effect for such aggregation resulted in a color change from red to purple within 3 min. With a LoD of 0.154 pg mL −1 , the testing system offered 96% sensitivity and 84% specificity. The estimated test cost was meager, approximately 15 cents. Despite the simplicity, affordability, and accessible scale-up possibilities, the commercialization status of this PoC technology is unknown. A search of FDA-approved COVID-19 testing did not produce any results related to using this technology. Magnetic nanobiosensors for COVID-19 detection In contrast to gold nanoparticles, which rely on optical properties, Magnetic nanoparticles (MNPs) offer alternative detection mechanisms based on magnetism, opening new avenues for nanobiosensor development. These are derived from iron and their oxides and have unique magnetic properties (Ali et al. 2021 ). Superparamagnetic iron oxides (MNPs), such as maghemite (Fe 2 O 3 ) and magnetite (Fe 3 O 4 ), are the choice for biological applications due to their high biocompatibility and low toxicity with better surface chemistry (Materón et al. 2021 ). Surface- and volume-based magnetic biosensors detect pathogens after coating MNPs with specific antibodies or DNA/RNA probes (Aytur et al. 2006 ). It detects the change in magnetic properties upon binding of pathogen-specific targets. The results are produced in low background noise, thus offering better accuracy and reliability than other nonmagnetic NBSs (Schotter et al. 2004 ). Pietschmann et al. ( 2021 ) developed one magnetic immunodetection-based PoC serological assayfor COVID-19 detection (Pietschmann et al. 2021 ). The authors prepared plant-derived recombinant SARS-CoV-2 S1 antigen and coated it onto a polyethylene matrix. The patient sera were treated with the matrix to allow specific antigen–antibody binding. It was labeled with synomag®-D, a commercially available streptavidin-functionalized dextran-coated maghemite (Fe 2 O 3 ) MNP with a hydrodynamic diameter of 70 nm. The magnetic signal (in millivolts) was detected using a handheld and portable frequency-mixing magnetic detection device. The principle and process of frequency mixing magnetic detection have been reviewed in areas of immunodetection through magnetic particle spectroscopy (MPS) platforms (Krause et al. 2007 ). The signal was proportional to the dose-dependent retention of bound MNPs. It was helpful for qualitative and quantitative measurement, including antibody titer determination. The assay had a turnaround time of 21 min and offered 97% sensitivity and 92% specificity over a commercial serological assay. Peroxidase enzyme-like behavior is well known for magnetic γ Fe 2 O 3 nanoparticles in the presence of substrate (H 2 O 2 ) (Nasir et al. 2017 ). Büyüksünetçi et al. ( 2021 ) used these enzymatic benefits to develop a simple colorimetric COVID-19 detection system (Büyüksünetçi et al. 2021 ). The authors developed a blue-colored oxidized form of 3,3′,5,5′-tetramethylbenzidine (TMB) by using a magnetic γ Fe 2 O 3 nanoparticle in the presence of H 2 O 2. The oxidized TMB was mixed with ACE2 receptor protein and incubated with oropharyngeal and nasopharyngeal swabs from patients containing virus spike protein. Virus-ACE2 binding induced a reduction reaction that transformed TMB colorless from blue and indicated positive samples. Giant magnetoresistance (GMR) is another phenomenon explored for MNP-based detection of COVID-19. In a study by Bayin et al. ( 2021 ), a superparamagnetic nanoparticle (SMNP) was developed by coprecipitating FeCl 3 ·6H 2 O and FeSO 4 ·7H 2 O (Bayin et al. 2021 ). The surface was carboxyl-modified and coupled with recombinant nucleocapsid protein (NP) or rabbit IgG. It was used to develop one sandwich-type lateral flow immunoassay (LFIA) strip. The strip could quantitatively detect anti-SARS-CoV-2 immunoglobulin M (IgM) and G (IgG) when used with a GMR sensor. The system detected IgM and IgG as low as ten ng/mL and five ng/mL, respectively. The evidence for commercializing magnetic NBS-based COVID-19 detection systems is minimal. Among the few, T2 Biosystems, Inc. had obtained the FDA’s Emergency Use Authorization (EUA) for its preoperatory T2SARS-CoV-2 Panel (T2 Biosystems 2024 ). The panel contains MNPs targeting SARS-CoV-2 and detects through the company’s NMR-based disease diagnosis platform. Magnetic nanobeads are another type of nanomaterial with a long history of use in biosensor development (Kabe et al. 2019 ). These beads are spherical and are slightly larger than traditional nanoparticles. Few researchers have used these magnetic nanobeads for COVID-19 detection. A magnetic NBS was developed by using dually labeled magnetic nanobeads and integrating them onto a microfluidic chip (Li and Lillehoj 2021 ). The construct accurately measured SARS-CoV-2 nucleocapsid protein in serum samples at concentrations as low as 50 pg/mL. The microfluidic assay was also adopted in handheld smartphone-based diagnostic devices to enhance PoC testing capabilities further. In another example, a chemiluminescence-based assay was developed using amino magnetic beads (MB-NH2) (Wang et al. 2021 ). The beads were surface-modified with reduced AuCl 4 and CoCl 2 . These were incorporated with N antibodies against SARS-CoV-2. The resultant sensor could bind N protein in spiked human serum and saliva samples with a 69 fg/mL LoD. A lateral flow immunoassay was also developed using fabricated multifunctional magnetic nanobeads as a sensor targeting virus N protein (Xie et al. 2022 ). The sensor containing a superparamagnetic Fe 3 O 4 core with dual quantum dot shells (MagDQD) produced magnetic and fluorescent signals upon binding with a virus particle. The test had a turnaround time of 10 min and had excellent sensitivity and specificity. Nonmetallic nanobiosensors for COVID-19 detection Nonmetallic nanomaterials such as oxides of cadmium, zinc, selenium, and carbon-based nanostructures have been alternative choices for developing sensors for pathogen detection (Malik et al. 2021 ). For COVID-19 detection, a selenium nanoparticle-based lateral flow immunoassay was developed by Wang et al. ( 2020 ). The NBS was prepared by incorporating the SARS-CoV-2 nucleoprotein onto a selenium nanoparticle. The assay detected anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human serum within 10 min. The assay showed 93.33% sensitivity and 97.34% specificity and had detection limits of 20 ng/mL and five ng/mL for IgM and IgG, respectively. In another attempt, an optical NBS was developed using a single-walled carbon nanotube (SWCNT) (Pinals et al. 2021 ). The nanotube was functionalized by binding with the ACE2 receptor. It fluoresces after binding with the SARS-CoV-2 spike protein within 90 min. Likewise, Cho et al. ( 2021 ) developed a SWCNT-based NBS with polyethylene glycol (PEG)─phospholipid heteropolymers on the surface (Cho et al. 2021 ). It created a unique antibody-free 3D interface that selectively detects the nucleocapsid (N) and spike (S) proteins of SARS-CoV-2. The results were obtained through near-infrared fluorescence with LoDs of 48 fM and 350 pM for the N and S proteins, respectively. Carbon Nanotubes (CNTs) were also used to develop electrochemical NBSs. For example, Thanihaichelvan et al. ( 2022 ) developed a Field-Effect Transistor (FET) by fabricating CNTs on flexible Kapton and immobilizing them with the reverse sequence of the RNA-dependent RNA polymerase gene of SARS-CoV-2 (Thanihaichelvan et al. 2022 ). Under an external electrical circuit with a silver-based reference electrode, the FET produced detectable electrical signals upon binding with virus genetic materials. In addition to CNTs, graphene nanoparticles have also been used to develop field-effect transistor (FET)-based NBSs for detecting COVID-19 (Seo et al. 2020 ). COVID-19 detection using breathalyzers The earlier sections described innovations that required sample collection from the infected or suspected individual. Collection of potentially contagious biological samples such as saliva, nasopharyngeal/oropharyngeal swabs, and serum requires training. Furthermore, pathogens dispersed in biological fluid undergo processing before being detected. This requires clinically trained experts for sample collection, testing, and reporting. Even the Lateral Flow-based home testing do-it-yourself kit provides a manual to train the user for appropriate sample collection and effective results. These are time-consuming and unsuitable for rapid population-wide screening, especially at strategically important checkpoints such as ports, rails, hospitals, and malls. As a potential solution to these challenges, breathalyzers have gained popularity due to their rapid, noninvasive nature. Exhaled breath has increasingly been recognized to carry individual metabolic signatures and aerosol-containing live pathogens and their particles, especially viruses in the upper respiratory tract. For a long time, breathalyzers with different sensing systems have been explored as alternatives to fluid-based pathogen detection systems (Gould et al. 2020 ). The innovations are contactless and completely noninvasive. The results are obtained within a few minutes, which makes it perfect for large-scale pathogen screening. For the detection of COVID-19, different nanomaterials were tested to develop breath analysis-based sensing systems. Leong et al. ( 2022 ) developed a handheld surface-enhanced Raman scattering-based breathalyzer (Leong et al. 2022 ). The sensor was made of silver nanocubes and could detect breath volatile organic compounds specific to COVID-19 infection within 5 min with more than 95% sensitivity and specificity. In another study, a portable handheld analyzer with eight different sensors was developed by Shan et al. ( 2020 ). The NBS comprised spherical gold nanoparticles containing multiple organic ligands to detect volatile compounds in SARS-CoV-2-infected individuals. The device records the change in sensor resistance upon swelling or shrinking after exposure to volatile organic compounds. The device, trained using a training and learning algorithm, resulted in 100% sensitivity and 69% specificity in COVID-19 detection, even in asymptomatic yet contagious individuals. The first author of this publication obtained an Indian patent (No. 452997) for developing a handheld, contactless, noninvasive COVID-19 detection device (Poddar 2023 ). The device detects viruses in the exhaled breath in symptomatic and asymptomatic individuals. For detection, the device contained a replaceable chip made of an electroconductive freestanding monolayer nanomembrane with the human ACE2 receptor and furin protease immobilized on it. The nanomembrane was made of polymeric nanoparticles by combining poly(2-methyl-2-oxazoline)-block-poly-(dimethylsiloxane)-block-poly(2-methyl-2-oxazoline) to mimic biological surfaces. The detection relies on bioelectrical recognition after the receptor-ligand binding. The presence of the virus in exhaled breath will be captured by the ACE2 receptor and undergo further cleavage by Furin protease. This receptor-ligand binding will result in bioelectrical changes that the device will capture after translating into measurable voltage changes. Impact on Global Health Security (GHS) threat countermeasures Challenges in global health security Humanity’s exposure to global health security threats is not new. COVID-19 has been the latest addition, with nearly 7 Million Deaths (WHO 2023 ). In addition, the pandemic impacted the global gross domestic product (GDP), causing significant economic contractions across various regions. The pandemic’s effects on GDP are multifaceted, involving direct health-related disruptions and indirect economic consequences from containment measures. A shock to consumption demand and equity risk premiums resulted in significant GDP losses for industrialized countries such as Japan, Germany, and the US. In contrast, oil-producing countries like Saudi Arabia experienced the least impact (Ahangar and Kim 2022 ). Stringent lockdown measures significantly influenced GDP, with more severe restrictions leading to greater economic contractions. For instance, the UK experienced nearly 10% reduction in annual growth due to social distancing and lockdowns (Gupta et al. 2023 ). Countries with large service sectors, such as Malaysia and Thailand, faced more severe GDP losses than those with diversified economies or large agricultural sectors (Bentzen and Tung 2024 ). The pandemic caused a significant drop in traded tourist services and increased trade costs, further exacerbating GDP declines. The economic effects were transmitted globally through trade, highlighting the interconnectedness of economies (Gagnon et al. 2023 ). The global average suggested a 3.4% drop in GPD in 2020. This was equivalent to over a trillion USD wiped out of the global economy (Dyvik 2024 ). The massive impact of such threats highlighted a global state of under-preparedness. It was reflected in the GHS index that revealed an existing disparity among nations in providing adequate support and infrastructure to detect, respond to, and contain the spread of diseases (GHS Index 2021 ). Most nations of the global South with disease hotspots still do not have inadequate laboratory infrastructure and limited trained human capacity for laboratory diagnosis. In this regard, the more worrying fact is that COVID-19 is not the end of such health security threats. Instead, the future hosts possibilities of more severe and deadly diseases. Therefore, the world cannot afford to relax; instead, it must be resilient. The lessons learned from COVID-19 strongly suggest strengthening the national and global capacities to prepare and respond against any such future threats. Past initiatives in diagnostics During the early days of the COVID-19 pandemic, global and national initiatives focused on improving access to rapid and affordable diagnostic kits. These efforts were crucial in controlling the spread of the virus by enabling timely detection and intervention. Various programs and collaborations were established to address the challenges of diagnostic access, particularly in underserved and low-income populations. The initiatives aimed to enhance the development, production, and distribution of diagnostic tests, ensuring they were accessible, affordable, and actionable. Launched in June 2020, WHO’s Access to COVID-19 Tools (ACT) Accelerator is the most notable global collaboration to accelerate the development and equitable access to COVID-19 tests, treatments, and vaccines. Under this initiative, 120 million affordable COVID-19 rapid tests were distributed in low- and middle-income countries, representing 80% of the COVID-19 tests performed (WHO 2020 ; Balakrishnan 2022 ). Additionally, the WHO’s COVID-19 Technology Access Pool aimed to expand equitable access to COVID-19 health products by providing a platform for sharing knowledge, intellectual property, and data. It facilitated technology transfer agreements to enhance the local production of diagnostic tests in LMICs (Chamas et al. 2022 ). At a national level, the US Government, through the National Institutes of Health (NIH), launched the Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) program to address the low rates of SARS-CoV-2 testing in underserved communities. This program provided community-based investigators with scientific expertise and resources to increase testing access and uptake among these populations, marking the most significant investment in health disparities research by the NIH (Narayanasamy et al. 2023 ). Likewise, the flagship Rapid Acceleration of Diagnostics (RADx®) initiative was launched on April 29, 2020, to promote innovation, commercialization, point-of-care, and rapid detection devices, tests, and home-based COVID-19 testing technologies. Six new promising technologies were identified within six months and further supported for scale-up and manufacturing. Luminostics, Inc., Milpitas, California, bagged a $26.1 million contract to scale up the company’s proprietary clip health technology platform based on the ‘Clip COVID Rapid Antigen Test’. It was a lateral flow immunoluminescent assay that binds the SARS-CoV-2 nucleocapsid protein by using strontium aluminum nanoparticles. The binding affinity was detected through a simple smartphone camera with AI-based signal processing (Paterson et al. 2017 ). The test had 100% specificity and 96.9% sensitivity in detecting the virus in shallow nasal swabs in 30 min or less. While these initiatives significantly improved access to COVID-19 diagnostics, challenges such as underinvestment in research and development, limited cooperation opportunities, and inequities in test distribution persisted. The pandemic highlighted the need for a coordinated global effort to promote diagnostics as a global good, ensuring that all countries can respond effectively to health crises. Addressing these challenges requires structural changes in the innovation system, including sharing intellectual property and strengthening public–private partnerships. The most straightforward way is to invest, innovate, and implement rapid, PoC detection strategies as the forefront attempt in biosurveillance for early detection, reporting, and containment at source before it could become the next big global event. It is especially relevant to enable and engage in global equity in disease detection capacities and capabilities. Potential of nanobiosensors NBSs hold significant potential for enhancing global equity in disease detection capacities and capabilities. The possibilities of nanobiosensors deployment in various healthcare settings, including resource-limited environments, are particularly relevant for addressing global health disparities, as it provides accessible, cost-effective, and efficient diagnostic solutions (Dhahi et al. 2024a ). Among all NBS-based COVID-19 diagnostics described here, the most exciting part is the repurposing potential of these innovations. The entire NBS architecture can detect other viruses by altering the target molecules, including potential health security threats. Considering that these NBS-based technologies have accuracy, specificity, and sensitivity almost equal to the gold-standard molecular methods, they can replace the need to develop a sensitive assay from scratch. It could fast-track the response mechanism against emerging public health threats. Therefore, it can potentially transform PoC pathogen diagnostics in a way that conventional serological assays cannot perform for lower sensitivity and false identifications. One of the significant requirements of PoC technology is that it requires easy and affordable approaches to visualize the results quickly. In this regard, almost all NBS-based innovations performed flawlessly. Interestingly, while some of the optical measurements used in LFA-based immunosensors are visible to the naked eye, some have been combined with the benefits of Artificial Intelligence (AI), Machine Learning (ML), and Internet of Things (IoT) technologies. This has enabled an easy readout in smart devices and a specifically designed handheld sensor system with remarkable precision with a turnaround time of between 15 min and 2 h. NBS has the potential to scale up the development of breathalyzer-based virus detection. It could be a game changer for biosurveillance. It should be helpful in the immediate screening and isolation of symptomatic and asymptomatic shredders (Khan et al. 2021 ). The benefits of these devices could only be compared with the lessons learned from using thermal screening to reduce the COVID-19 scare even after a vaccine was introduced. NBS, therefore, can offer a benchmark for global health security, both natural and deliberate, by showing a way of transition from PoC to point-of-entry screening (PoES) for airborne agents. Market presence of COVID-19 nanobiosensors The experiences from NBS-based PoC technologies for COVID-19 detection are promising for further R&D, innovation, and applications. However, bench-to-bedside translation of these is comparatively limited compared to traditional detection strategies such as serological and molecular methods. Among many innovations, only a handful, most of which were lateral flow-based immunodiagnostics, were witnessed in the market. Only 17 LFIA had used NBS out of 217 US-FDA’s EUA (Emergency Use Authorisation) approved test kits (Table 1 ). In contrast, countries like India have validated and approved 169 rapid test kits, yet none depend on NBS architecture. Interestingly, despite the Indian regulator, the Central Drugs Standard Control Organisation (CDSCO) exempts further regulatory validation of imported kits, not a single FDA-approved NBS-based kit was imported and commercialized in the Indian market. It indicated that commercial sectors are comfortable investing in traditional serological paper strip-based visual diagnostics that are cheap, easily scalable, and amenable to individual and population needs (Ochola et al. 2022 ). This situation demands an introspection to understand the bottlenecks for broader commercialization of NBS-based tests at different stages of development from research to commercialization. For example, the federally funded Luminostics, Inc.’s ‘Clip COVID Rapid Antigen Test’ obtained the FDA’s EUA on March 4, 2022; however, it was later revoked. Likewise, Sona Nanotech Inc. abruptly withdrew its interim order authorization (“IO”) application from Health Canada for its highly advertised gold nanorod technology-based COVID-19 detection system. These few examples point out that clinical performance and validity of NBS do not always correlate with laboratory findings and may fail at later stages. These observations may discourage further federal investments in the background of spending millions of dollars for R&D in NBSs with limited hope for commercialization. For example, India initiated and continued R&D support towards nanotechnology in mission-mode programs through its federal funding ecosystem. However, in 15 years, no indigenous NBS innovations appeared from India on NBS-based COVID-19 diagnostics. Therefore, in considering the promotion of NBS in the future, shortlisting such hurdles at each stage of development is crucial. It will find solutions to translate the product by ensuring bench-to-bedside performance, access, affordability, and, finally, the returns on investment. The US FDA issued a guidance on the Policy for Coronavirus Disease-2019 Tests on February 29, 2020. It was revised in January 2023 (Health 2023). The Policy was driven under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and laid the roadmap for emergency use authorization of in vitro diagnostics to detect SARS-CoV-2. FDA has no special or separate regulatory treatment for NBS-based devices compared to other detection systems. Therefore, irrespective of the sensor and underlying technologies, all COVID-19 detection devices followed the same validation and approval mechanisms. Likewise, India, the other largest consumer nation in the global South, had similar regulatory approaches for dealing with in vitro diagnostics under the 1945 Drugs and Cosmetics Act and Rules. The Indian Council of Medical Research (ICMR), in consultation with Drug Controller General of India (DCGI), approved indigenous COVID-19 detection devices following cutoff-based acceptance criteria. Interestingly, US-FDA and WHO-EUA-approved kits and devices were exempted from further regulations for their entry into the Indian market. Therefore, regulatory hurdles could in no way prevent or delay the marketing of NBS-based COVID-19 diagnostics. Way forward The limited availability of commercial NBSs points to translational challenges between laboratory and commercial manufacturing. Overcoming these challenges necessitates administrative control in early developmental stages as a key component of translational success. However, it is not the developers’ sole duty. It requires cross-sectoral integration to ensure that innovations are targeted to demand resolutions and sufficient transparency and accountability lie in the bench to bedside innovation. The need and demand for NBS-based detection of pathogens, including emerging infections, will be high and relevant for PoC diagnostics targeting resource-poor settings. A tiered and informed administration control can manage the research into the market. Funding agencies must optimize the research fund flow to improve downstream development pipelines. In this, incentivization may be considered for developers to increase technology readiness, leading to technology transfers. In parallel, commercialization hurdles need to be adequately addressed for successful translation. The commercial roadmap begins with identifying market needs for a specific analyte, application (such as PoC diagnostics, environmental monitoring, or food safety), or target deployment. This includes demonstrating a clear advantage of the NBSs over existing techniques, rigorously verifying their functionality both during operation and after storage, and ensuring their performance remains viable for a commercially relevant timeframe (e.g., at least six months) (Ulucan-Karnak et al. 2024 ). A primary hurdle lies in scalable and cost-effective manufacturing. The roadmap must address production costs and manufacturing feasibility, specifically focusing on scalable nanofabrication processes that transition from laboratory-scale synthesis to high-volume production. This includes optimizing material synthesis, device fabrication, and integration processes while maintaining consistent nanomaterial properties and device performance. Furthermore, the unique signal transduction mechanisms of NBSs require careful consideration during development and optimization to ensure reliable and reproducible measurements. Critically, regulatory pathways pose a substantial challenge. Establishing a transparent and efficient regulatory strategy is essential. This involves thoroughly addressing concerns related to nanomaterial toxicity, potential health effects, and environmental impact during the R&D phase (Dhahi et al. 2024b ). Potential issues such as nanoparticle leakage, migration, long-term environmental fate, and specific toxicity concerns related to the chosen nanomaterials must be resolved to ensure safe application, particularly in sensitive areas like food safety and in vivo diagnostics. Regulatory considerations must also account for the stability and characterization of the nanomaterials themselves, including size distribution, surface properties, and potential for aggregation, requiring robust analytical methods for characterization and quality control. Addressing these technical and regulatory hurdles is crucial. However, market adoption also depends on demonstrating a clear value proposition and addressing user needs. The roadmap must include needs assessment, scoping, product development, production, sales, and distribution strategies tailored to the target market. Evidence must demonstrate the cost-effectiveness, ease of use, and compatibility with existing infrastructure. Finally, ongoing post-market surveillance to monitor long-term safety, performance, and environmental impact is essential for maintaining regulatory compliance and building public trust. Conclusion As of May 11, 2023, COVID-19 is no longer classified as a public health emergency. The PHE status expired on May 11, 2023, by the US Department of Health and Human Services (HHS) (CDC 2020 ). However, cases persist across nations, with 10,000–15,000 new infections reported daily (WHO 2023 ). The virus constantly evolves, with JN.1 being the latest addition as a ‘variant of interest’ (Looi 2023 ). Predicting whether the virus will be eliminated or attain endemic status is complicated. As such, it is necessary to continue global R&D efforts to develop affordable and rapid diagnostic tools and technologies, especially for resource-limited nations. Difficult times often pave the way for relevant and timely innovations. That is how one can describe the development and application of NBSs in detecting SARS-CoV-2. Primarily, this review accounts for significant innovations in COVID-19 diagnostics and the role of nanotechnology. It also reflects rapid PoC innovations that could be repurposed immediately to respond against new and emerging health security threats from both natural and deliberate origins. This is relevant owing to the inevitability of the next pandemic with a much more intense warning sign. NBS-based devices amalgamate cross-sectoral advanced technologies and have the potential to replace time-consuming and resource-intensive molecular technology. The R&D and innovation landscape of NBS-based COVID-19 biosensors is quite promising. It reflects the global attention paid to developing such detection devices, the intensity of research, and funding support. NBS with proof of concept has shown good sensitivity and specificity, and some offer significantly lower sample processing costs. Interestingly, affordable innovative devices based on pencil graphite, adhesive bandages, swab collection, etc., have a high chance of commercialization. In particular, contactless devices focused on detecting virus particles in exhaled breadth carry more rewards for nations for possible deployment at the point of entry. Ideally, these could address the affordability and equity issues in diagnostic healthcare sectors if scaled up to meet the global need. Instead of relying on classical nanomaterial formulation strategies, many scientific breakthroughs can be considered to improve manufacturing efficiency. In this, nanofabrication assembly witnessed remarkable progress. Multiple strategies of bottom-up fabrication involving self and directed nanoparticle assembly gained attention over the physicochemical approaches (Chai et al. 2022 ). However, each has merits and demerits over others, and so can never be the one-size-fits-all approach. Developers used electric, magnetic, optical, and fluidics as external fields for the directed fabrication of different nanomaterials. Microfluidics platforms have shown great commercial promise – reproducibility, consistency, and low-cost manufacturing processes. It also creates an efficient production line by miniaturization and automation, allowing mass production by precision control over each step. In fact, both supervised and unsupervised AI and machine learning are emerging in significant ways to gain precision production controls regarding nanoparticle accuracy and desirable properties (Chen and Lv 2022 ). However, the machine training databases are still being developed and will require time to enrich and cater to commercial needs. Microfluidic platforms hold great potential in nanomedicine, especially for drug delivery areas (Gimondi et al. 2023 ). In contrast, nanoparticle self-assembly relies on the natural process of creating an ordered structure at the liquid–liquid interface of two immiscible liquids. Although the process is unregulated compared to the directed assembly, the simple, spontaneous formation generates robust and responsive 2D and 3D nanomaterial structures that respond to biological stimuli. Such self-assembled nanomaterials have also been found promising in the drug delivery sector. The latest in the fold of fabrications is the creation of DNA nanostructures using DNA origami, which ultimately attempted a revolution in the 3D printing of nanoparticles. DNA origami-based structures like DNA assemblies, superstructures, nanodevices, etc., hold excellent potential in the biomedical sector in drug delivery and biosensor applications (Zhan et al. 2023 ). However, it is still in its infancy. It will require more testing, including process optimization, scaling up conditions, etc., before enabling mass-scale DNA-based nanomaterial development (Zhang et al. 2023 ). The actual game changer could be directly printing the nanomaterials in 3D for commercial fabrication of nanomaterials (Jain et al. 2021 ). Focused-electron-beam induced deposition (FEBID) and Two-photon lithography (TPL) technology have enabled direct printing of nanostructures with impressive sensitivity. This could revolutionize sensor production, enabling on-demand, localized creation of customized sensors, significantly reducing time and cost. Although NBSs offer significant potential to revolutionize diagnostics for improved global health security, their practical application is constrained by existing translational bottlenecks. While potential mitigation strategies have been discussed here, a rigorous and systematic assessment is necessary to identify the critical bottlenecks impeding the broader commercialization of NBS-based pathogen detection technologies. To achieve this, technology developers, industries, policymakers, and stakeholders must convene, discuss the intricacies, and determine how to adopt these novel and precision NBS-based technologies to strengthen the rapid diagnostic arena. In this direction, the US National Nanotechnology Coordination Office (NNCO), under the National Nanotechnology Initiative (NNI), held a workshop in 2017 to develop an improved manufacturing roadmap (National Nanotechnology Coordination Office 2017 ). The workshop identified key challenges in developing standards for nanotechnology-enabled sensors due to market fragmentation by bringing together a wide range of stakeholders. Participants emphasized the need for collaboration among federal, private, and academic sectors to accelerate commercialization. They also highlighted the importance of reproducibility in sensor manufacturing to reduce extensive batch testing. They underscored the complexity of supply chain management, advocating for clear material specifications and proactive supplier engagement. Invariably, there is a need to increase such deliberations across nations to advance and implement NBS at the forefront of diagnostics. Such workshops can provide a vital platform for countries to tailor their nanotechnology roadmaps to specific factors, optimizing resource allocation, navigating diverse regulations, and addressing unique societal needs. 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