Point Of Care Diagnostic Device Research Articles

Molecular Point-of-Care Assay Development: Design and Considerations.

Molecular diagnostic point-of-care (MDx POC) testing is gaining momentum and is increasingly important for infectious disease detection and monitoring, as well as other diagnostic areas such as oncology. Molecular testing has traditionally required high-complexity laboratories. Laboratory testing complexity is determined by utilizing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Categorization Criteria scorecard, utilizing seven criteria that are scored on a scale of one to three. Previously, most commercially available point-of-care (POC) tests use other analytes and technologies that were not found to be highly complex by the CLIA scoring system. However, during the COVID-19 pandemic, MDx POC testing became much more prominent. Utilization during the COVID-19 pandemic has demonstrated that MDx POC testing applications can have outstanding advantages compared to available non-molecular POC diagnostic tests. This article introduces MDx POC testing to students, technologists, researchers, and others, providing a general algorithm for MDx POC test development. This algorithm is an introductory, step-by-step decision tree for defining a molecular POC diagnostic device meeting the functional requirements for a desired application. The technical considerations driving the decision-making include nucleic acid selection method (DNA, RNA), extraction methods, sample preparation, number of targets, amplification technology, and detection method. The scope of this article includes neither higher-order multiplexing, nor quantitative molecular analysis. This article covers key application considerations, such as sensitivity, specificity, turnaround time, and shipping/storage requirements. This article provides an overall understanding of the best resources and practices to use when developing a MDx POC assay that may be a helpful resource for readers without extensive molecular testing experience as well as for those who are already familiar with molecular testing who want to increase MDx availability at the POC. © 2024 Wiley Periodicals LLC.

Novel hapten design, highly sensitive monoclonal antibody production, and immunoassay development for rapid screening of illegally added chloramphenicol in cosmetics

Hapten design and synthesis have been regarded as the key factor to generate high-quality antibodies. In the present study, a novel hapten of chloramphenicol was synthesized, characterized and compared with two conventional haptens. The new hapten generated mAb 4B5 showed higher sensitivity and titer than the other two haptens-based mAbs. The haptens synthesized with the structure of chloramphenicol base generated more sensitive antibodies than the hapten with chloramphenicol succinate, and the spacer arm linked to the phenyl group hapten elicited the strongest antibody response. After optimization, a direct competitive enzyme-linked immunosorbent assay (dcELISA) and a lateral flow immunoassay (LFIA), both based on the mAb 4B5, were developed. The dcELISA had a half maximum inhibition concentration of 0.23 ng/mL and the LFIA showed a cutoff value of 5–10 ng/mL. The LFIA was applied to detect illegally-added chloramphenicol samples in anti-acne cosmetics, five out of 19 samples were tested chloramphenicol containing within 10 min, which result was confirmed with the dcELISA and HPLC. The LFIA has an adequate sensitivity and can be used as a point of care diagnostic device for rapidly screening chloramphenicol in cosmetics.

Reduced-Order Model for Surfactant-Laden Electrified Sessile Droplets.

A comprehensive understanding of the physics of electrowetting of a surfactant-laden droplet is important for applications in rapid healthcare diagnostics. A majority of biological samples examined during point-of-care (POC) diagnostics are biofluids with dissolved surfactants, such as the respiratory droplets containing protein (mucin) and surfactant molecules like dipalmitoylphosphatidylcholine. The presence of these surfactant molecules is anticipated to have a significant impact on the performance of electrowetting-based POC diagnostic devices. A reduced-order model is developed using the weighted residual integral boundary layer theory for the electrowetting of a surfactant-laden sessile droplet in a parallel plate electrode configuration. Thin film evolution equations are obtained for the fluid-fluid interface, the surfactant concentration, the depth-integrated flow rate, and the interfacial charge density. We show that the presence of surfactants opposes and decreases the strength of the electrohydrodynamic flow due to Marangoni stress-driven convection. The droplet then responds to an AC field with a suppressed amplitude of oscillation and the same mean deformation as that under DC forcing. Thus, low-frequency AC forcing with a suitable surfactant can plausibly be employed as a viable alternative to more energy-intensive high-frequency AC forcing.

Metasurface-assisted Lab-on-fiber optrode for highly sensitive detection of vitamin D

The increasing demand for vitamin D status assessment has highlighted the need for rapid, sensitive, and user-friendly methods for its detection in biological samples potentially integrated in Point-of-Care (PoC) diagnostic devices. Detection of the major circulating form of vitamin D, 25-hydroxyvitamin D3-25(OH)D3, is particularly challenging due to the laborious procedures for sample preparation and its low molecular weight (∼400 Da), which requires highly sensitive detection methods. In this study, we developed a novel label-free Lab-on-Fiber biosensing platform for highly sensitive detection of 25(OH)D3 based on the integration of plasmonic metasurfaces (MSs) on the tip of a single-mode optical fiber (OF). A dedicated pipeline was carefully designed and developed to optimize the bio-functionalization of the plasmonic sensor tip to specifically detect the target biomolecule. The resulting MS-assisted Lab-on-fiber platform enables direct and highly sensitive detection of 25(OH)D3 in clinically relevant ranges (4–160 ng/mL), both in buffer solution and complex matrix, with limits of detection (LOD) of 1.40 ng/mL in saline buffer and 0.85 ng/mL in complex matrix. Overall, these results demonstrate that our platform can successfully and specifically detect small molecules in label-free configuration, with performances comparable to those of conventional methods used in clinical practice. The high degree of miniaturization combined with its high sensitivity makes our platform an exceptional building block for realizing valid diagnostic alternatives for label-free detection of clinically relevant analytes, which can be transformed into new low-cost, fast, simple, and ready-to-use PoC diagnostic devices with improved processability and performance compared to current methods.

A multistep immunoassay on a 3D-printed capillarity-driven microfluidic device for point-of-care diagnostics

Although efficient diagnostic testing often relies on centralized laboratories, rapid diagnostics at the point-of-care (POC) are increasingly investigated to provide an affordable and easy-to-use alternative that requires minimal external equipment. Implementing complex assays on such POC devices is challenging, and existing methods such as paper-based analytical devices suffer from laborious and heterogeneous fabrication. 3D printing is a promising technology to enable the single-step fabrication of such diagnostic devices. We previously reported monolithic, 3D-printed microfluidics driven by capillarity, and used the platform to implement a proof-of-concept enzyme-linked immunosorbent assay (ELISA) for immunoglobulin E (IgE) detection. In this study, we aimed to improve the time-to-result and detection limit of this approach by (i) designing a second-generation 3D-printed device and (ii) further optimizing the IgE ELISA. Herein, we selected horseradish peroxidase for faster and more sensitive signal amplification compared to the first-generation device, for which we adapted the microfluidic device design to allow sequential flow while using separated reagent channels for each assay step. To implement the ELISA on this new design, we decreased reagent volumes and incubation times to be compatible with POC, and then we translated this assay stepwise from microtiter plates to the completely 3D-printed, second-generation device. Overall, this work gives additional insight into the biocompatibility of these 3D-printed devices, as well as demonstrates the huge potential of powder bed 3D printing to fabricate POC diagnostic devices.

Modeling and Characterization of Pre-Charged Collapse-Mode CMUTs

Recently, the applications of ultrasound transducers expanded from high-end diagnostic tools to point of care diagnostic devices and wireless power receivers for implantable devices. These new applications additionally require that the transducer technology must comply to biocompatibility and manufacturing scalability. In this respect, Capacitive Micromachined Ultrasound Transducers (CMUTs) have a strong advantage compared to the conventional PZT based transducers. However, current CMUTs require a large DC bias voltage for their operation, which limits the miniaturizability of these devices. In this study, we propose a pre-charged collapse-mode CMUT for immersive applications that can operate without an external bias by means of a charge trapping Al <sub xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">2</sub> O <sub xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">3</sub> layer embedded in the dielectrics between the top and bottom electrodes. The built-in charge layer was analytically modeled and four layer stack combinations were investigated and characterized. The measurement results of the CMUTs were then used to fit the model and to quantify the amount and type of trapped charge. It was found that these devices polarize due to the ferroelectric-like behavior of the Al <sub xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">2</sub> O <sub xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">3</sub> , and the amount of charge stored in the charge-trapping layer was estimated to be approximately 0.02C/m <sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">2</sup> . Their acoustic performance shows a transmit and receive sensitivity of 8.8 kPa/V and 13.1V/MPa respectively. In addition, we show that increasing the charging temperature, the charging duration, and the charging voltage results in a higher amount of stored charge. Finally, results of ALT tests showed that these devices have a lifetime of more than 2.5 years at body temperature.

A cork based substrate coupled with artificial antibodies for point-of-care detection of pro-inflammatory cytokine biomarkers

A cork based point of care diagnostic device for monitoring cytokine biomarkers in biofluids.

Smart Microfluidics: Synergy of Machine Learning and Microfluidics in the Development of Medical Diagnostics for Chronic and Emerging Infectious Diseases.

The COVID-19 pandemic, emerging/re-emerging infections as well as other non-communicable chronic diseases, highlight the necessity of smart microfluidic point-of-care diagnostic (POC) devices and systems in developing nations as risk factors for infections, severe disease manifestations and poor clinical outcomes are highly represented in these countries. These POC devices are also becoming vital as analytical procedures executable outside of conventional laboratory settings are seen as the future of healthcare delivery. Microfluidics have grown into a revolutionary system to miniaturize chemical and biological experimentation, including disease detection and diagnosis utilizing μPads/paper-based microfluidic devices, polymer-based microfluidic devices and 3-dimensional printed microfluidic devices. Through the development of droplet digital PCR, single-cell RNA sequencing, and next-generation sequencing, microfluidics in their analogous forms have been the leading contributor to the technical advancements in medicine. Microfluidics and machine-learning-based algorithms complement each other with the possibility of scientific exploration, induced by the framework's robustness, as preliminary studies have documented significant achievements in biomedicine, such as sorting, microencapsulation, and automated detection. Despite these milestones and potential applications, the complexity of microfluidic system design, fabrication, and operation has prevented widespread adoption. As previous studies focused on microfluidic devices that can handle molecular diagnostic procedures, researchers must integrate these components with other microsystem processes like data acquisition, data processing, power supply, fluid control, and sample pretreatment to overcome the barriers to smart microfluidic commercialization.

Polyaniline‐Based Nanostructure Interface for Signal‐to‐Noise Ratio Enhancement in Potentiometric Enzyme‐Free Biosensors

AbstractReduction of nonspecific signals (noise) in electrochemical biosensors is important for the realization of enzyme‐free, point‐of‐care (POC) diagnostic devices. In this study, a simple biosensor interface that simultaneously realizes analyte signal enhancement and noise reduction to increase signal‐to‐noise ratio in a field‐effect transistor‐based potentiometric biosensor is proposed. As a proof‐of‐concept, a phytic‐acid‐doped self‐functionalized polyaniline (pAni)‐based nanostructure is designed. It is shown that the incorporation of gold nanoparticles in the nanostructure increases the signal intensity in serotonin sensing. Moreover, the phenylboronic acid moiety in the pAni backbone and porous nanostructure of the pAni nanostructure reduces the interfering noise generated by catecholamines and human serum albumin. It is believed that this study will contribute to the realization of versatile and multiplexed POC diagnostic devices in the future.

A Low-Cost Cellulose-Based POC Device for Detection of COVID-19

Point-of-care diagnostic (POC) is of utmost importance for the fight against pandemics which provides easy, instant results right at your place. POC can transform healthcare management and create superior infrastructure. In POC, employing lateral flow assays (LFAs) can accelerate the assessment and shorten the treatment time. LFA is a small handheld device made from paper that controllably delivers the analyte without the need of an active pump to the detection area to produce the signal, generally coloured nanoparticles (Au, carbon).Conventional LFA device is made of four components, sample pad, conjugate pad, nitrocellulose membrane and absorbent pad arranged sequentially. At the sample pad, the analyte is dispensed. From here, the analyte moves to the conjugate pad and hybridizes with recognition antibodies (placed onto nanoparticles) to form analyte-antibody-gold nanoparticles conjugate. Further movement takes this to the nitrocellulose membrane. Here, other recognizant antibodies are placed at the test and control line to immobilize by forming the sandwich assay with the analyte-antibody-gold nanoparticles. The excess liquid is absorbed in the absorbent pad. From these components of the LFA device, nitrocellulose membrane and antibodies need replacements as they increase the device's overall cost. Cellulose paper holds promise to counter nitrocellulose membrane; however, the development of fabrication methods for cellulose paper-based LFA devices is needed. In comparison to antibodies, aptamers improve batch-to-batch variability, ruggedness, and longevity of LFA devices.This work describes the fabrication of half-strip cellulose paper (Whatman® Grade 4 filter paper) based LFA device exploiting aptamers as the recognition element for antigen detection. The covalent bonding of aptamers was achieved by NanoCheck-ATH® (NC) and p-phenylene disothiocyanate (PDITC). NC provides plentiful amine functional groups and constricts the test line width by covalently bonding aptamer to the NC region only. The chitosan-based NanoCheck on paper assists in realizing sharp test and control lines by providing the controlled surface for PDITC reaction through amine groups. PDITC functions as a linker between NC and aptamers. Finally, a proof-of-concept nucleocapsid protein of SARS-CoV-2 as an antigen detection was shown with the minimal detectable concentration down to ~20 ng/mL with excellent selectivity towards casein, BSA, and albumin. We envisage that using facile modification chemistry of NC, PDITC, and aptamers for antigen detection will allow the fabrication of paper-based LFA devices in a roll-to-roll setting and, thus, decrease the overall cost. The developed method is generic and can be adapted to detect other antigens to fight future pandemics.

Preliminary Evaluation of a Novel Point of Care Diagnostic Device for Sports-Related Concussion.

Visinin-like protein 1 (VILIP-1) is a neuron-specific calcium sensor protein rapidly released into blood after mild traumatic brain injury (mTBI) and may be a suitable biomarker for identification of sports-related concussion (SRC). The objective of the study is to test if quantification of a specific post-translationally modified (ubiquitinated) form of VILIP-1 (ubVILIP-1) from a fingerstick blood sample using a point of care (POC) lateral flow device (LFD) can be used to rapidly identify athletes with SRC. Prospective cohort study. Side-line blood collection at football, soccer, and volleyball games/practices. Division I athletes with/without SRC. Blood ubVILIP-1 concentrations. Data collected over 2 athletic seasons from non-SRC athletes (controls) show a small but statistically significant elevation of ubVILIP-1 over an individual season for male athletes (P = 0.02) dependent on sport (P = 0.014) and no significant changes in ubVILIP-1 levels between seasons. For SRC athletes, the data show ubVILIP-1 levels substantially increase above baseline as soon as 30 minutes postdiagnosis with peak concentrations and times postinjury that vary based on injury severity. Results of the study suggest quantification of blood ubVILIP-1 levels measured using an LFD may provide an objective identification of athletes with SRC, setting the stage for further study with a larger number of SRC patients.

Point-of-Care and Label-Free Detection of Porcine Reproductive and Respiratory Syndrome and Swine Influenza Viruses Using a Microfluidic Device with Photonic Integrated Circuits.

Swine viral diseases challenge the sector’s sustainability by affecting productivity and the health and welfare of the animals. The lack of antiviral drugs and/or effective vaccines renders early and reliable diagnosis the basis of viral disease management, underlining the importance of point-of-care (POC) diagnostics. A novel POC diagnostic device utilizing photonic integrated circuits (PICs), microfluidics, and information and communication technologies for the detection of porcine reproductive and respiratory syndrome virus (PRRSV) and swine influenza A (SIV) was validated using spiked and clinical oral fluid samples. Metrics including sensitivity, specificity, accuracy, precision, positive likelihood ratio (PLR), negative likelihood ratio (NLR), and diagnostic odds ratio (DOR) were calculated to assess the performance of the device. For PRRSV, the device achieved a sensitivity of 83.5%, specificity of 77.8%, and DOR values of 17.66, whereas the values for SIV were 81.8%, 82.2%, and 20.81, respectively. The POC device and PICs can be used for the detection of PRRSV and SIV in the field, paving the way for the introduction of novel technologies in the field of animal POC diagnostics to further optimize livestock biosecurity.

'All In One' SARS-CoV-2 variant recognition platform: Machine learning-enabled point of care diagnostics

Point of care (PoC) devices are highly demanding to control current pandemic, originated from severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2). Though nucleic acid-based methods such as RT-PCR are widely available, they require sample preparation and long processing time. PoC diagnostic devices provide relatively faster and stable results. However they require further investigation to provide high accuracy and be adaptable for the new variants. In this study, laser-scribed graphene (LSG) sensors are coupled with gold nanoparticles (AuNPs) as stable promising biosensing platforms. Angiotensin Converting Enzyme 2 (ACE2), an enzymatic receptor, is chosen to be the biorecognition unit due to its high binding affinity towards spike proteins as a key-lock model. The sensor was integrated to a homemade and portable potentistat device, wirelessly connected to a smartphone having a customized application for easy operation. LODs of 5.14 and 2.09 ng/mL was achieved for S1 and S2 protein in the linear range of 1.0–200 ng/mL, respectively. Clinical study has been conducted with nasopharyngeal swabs from 63 patients having alpha (B.1.1.7), beta (B.1.351), delta (B.1.617.2) variants, patients without mutation and negative patients. A machine learning model was developed with accuracy of 99.37% for the identification of the SARS-Cov-2 variants under 1 min. With the increasing need for rapid and improved disease diagnosis and monitoring, the PoC platform proved its potential for real time monitoring by providing accurate and fast variant identification without any expertise and pre sample preparation, which is exactly what societies need in this time of pandemic.

Synthesis and characterization of TEMPO-oxidized peptide-cellulose conjugate biosensors for detecting human neutrophil elastase

Here we describe the synthesis and characterization of a peptide-cellulose conjugate biosensor based on TEMPO-oxidized nanofibrillated cellulose (tNFC) for detecting elevated levels of human neutrophil elastase (HNE) in chronic wounds. The fluorescent peptide HNE substrate constructed from n-succinyl-Ala-Pro-Ala-7-amino-4-methyl-coumarin was attached to the TEMPO-oxidized cellulose surface via polyethylene glycol linker. The characterization of the biosensor conjugate shows a high degree of peptide incorporation onto the surface with the degree of substitution of 0.057. The relatively small crystallite size of 26.0 Å compared to other cellulose- and nanocellulose-based materials leads to a large specific surface area which can promote access of HNE to the enzyme substrates due to decreased steric interactions. Likewise, the porosity for tNFC was found to be higher than all other samples, including the nanocellulosic aerogel, lending to its hydrogel-like nature. The properties of tNFC were compared to other cellulose-based materials. The volume of each crystallite and volume ratio to the largest sample was calculated. tNFC was found to occupy the smallest space resulting in high amounts of sensors per crystallite unit volume. With a small crystallite volume and large number of sensors, the tNFC peptide-cellulose conjugate biosensor could provide a more sensitive system and is a good candidate for point of care diagnostic devices for detecting elevated protease levels in humans.

Systematic Review and Meta-Analysis of the Diagnostic Accuracy of Mobile-Linked Point-of-Care Diagnostics in Sub-Saharan Africa.

Mobile health devices are emerging applications that could help deliver point-of-care (POC) diagnosis, particularly in settings with limited laboratory infrastructure, such as Sub-Saharan Africa (SSA). The advent of Severe acute respiratory syndrome coronavirus 2 has resulted in an increased deployment and use of mHealth-linked POC diagnostics in SSA. We performed a systematic review and meta-analysis to evaluate the accuracy of mobile-linked point-of-care diagnostics in SSA. Our systematic review and meta-analysis were guided by the Preferred Reporting Items requirements for Systematic Reviews and Meta-Analysis. We exhaustively searched PubMed, Science Direct, Google Scholar, MEDLINE, and CINAHL with full text via EBSCOhost databases, from mHealth inception to March 2021. The statistical analyses were conducted using OpenMeta-Analyst software. All 11 included studies were considered for the meta-analysis. The included studies focused on malaria infections, Schistosoma haematobium, Schistosoma mansoni, soil-transmitted helminths, and Trichuris trichiura. The pooled summary of sensitivity and specificity estimates were moderate compared to those of the reference representing the gold standard. The overall pooled estimates of sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio of mobile-linked POC diagnostic devices were as follows: 0.499 (95% CI: 0.458–0.541), 0.535 (95% CI: 0.401–0.663), 0.952 (95% CI: 0.60–1.324), 1.381 (95% CI: 0.391–4.879), and 0.944 (95% CI: 0.579–1.538), respectively. Evidence shows that the diagnostic accuracy of mobile-linked POC diagnostics in detecting infections in SSA is presently moderate. Future research is recommended to evaluate mHealth devices’ diagnostic potential using devices with excellent sensitivities and specificities for diagnosing diseases in this setting.

Electrical and Label-Free Detection of T-Cell Activation Against COVID-19: A Method Towards Point-of-Care Monitoring of Immune System

Despite great progress in biotechnology, COVID19 has revealed the inadequacy of current healthcare technologies to contain an infectious outbreak, specifically in rapid infection recognition to facilitate containment. Wide deployment of testing methods such as viral RNA (antigen) PCR and antibody detection have provided some relief in this regard; however, current technologies still require many hours to provide results. Thus, there remains a critical need for fast, sensitive, low-cost point-of-care (POC) biosensing assays to report on the infection status and immunity of patients. Emerging data on the importance of T-cell responses in generating long-term immunity against COVID19 has highlighted T-cell activation detection as a potential way for real-time monitoring native and acquired immunity. However, current approaches for T-cell stimulation monitoring are complex, laborious, time-consuming, and costly.Here we provide proof-of-principle experiments which indicate that an electrical and label-free detection method based on CMOS-compatible silicon nanowire ion-selective field-effect transistors (SNW-ISFET) can act as a fast, sensitive, reliable, and low-cost approach to monitor T-cell response to pathogens such COVID-19. This technology enables direct detection of COVID-19-specific T-cells directly from patient blood, with potential utility as a POC diagnostic device. Detection of antigen-specific T-cell activation from clonal human T-cells lines utilizing CD8-restricted peptide-MHC complexes has been demonstrated using SNW-ISFET devices. The cell concentration was varied to achieve a clear understanding about the device sensitivity, detection limit, and reliability (Figure 1). SNW-ISFET structures were applied to detect T-cell activation in clonal T-cell lines and whole peripheral blood mononuclear cell (PBMC) with multiple cell concentrations (Figure 2). Reference experiments were applied to ensure the device reliability and sensing mechanism (Figure 3). These findings show that SNW-FETs platform are promising candidates for antigen-specific T-cell activation detection from whole blood. Figure 1

A Snapshot of Microfluidics in Point‐of‐Care Diagnostics: Multifaceted Integrity with Materials and Sensors

AbstractOver four decades, point‐of‐care (POC) technologies and their pivotal applications in the biomedical arena have increased irrepressibly and allowed to realize the potential of portable and accurate diagnostic strategies. Today, in the light of these advances, POC systems dominate the medical inventions and bring the diagnostics to the bedside settings, potentially minimizing the workload in the centralized laboratories, as well as remarkably reducing the associated‐cost and time. In contrast to the conventional technologies, microfluidics paves the way to create more efficient and applicable POC diagnostic devices through their inherent fashions such as minute volume of samples, easy manipulations, shorter assay time, and low‐cost production. In this review, the current status and advancements of microfluidic systems along with the current limitations in the aspect of POC diagnostic strategies are elaborated. Further, the integration of novel materials and innovative sensing platforms to the microfluidic systems are comprehensively evaluated to address the real‐world challenges for diagnosing various maladies at the POC settings.

Point of Care Diagnostic Devices for Rapid Detection of Novel Coronavirus (SARS-nCoV19) Pandemic: A Review

Coronaviruses are recognized as causative agents of human diseases worldwide. In Wuhan, China, an outbreak of Severe acute respiratory syndrome novel Coronavirus (SARS-nCoV-2) was reported at the end of December 2019, causing 63 million COVID cases and 1.3 million deaths globally by 2 December, 2020. The transmission risk forecasts and the SARS-nCoV-2 epidemic pattern are progressive. Unfortunately, there is no specific FDA approved drugs or vaccines available currently to treat SARS-nCoV-2. In response to nCoV-2 spread, the rapid detection is crucial for estimating the severity of the disease and treatment of patients. Currently, there are several RT-PCR based diagnostic kits available for SARS-nCoV-2 detection, which are time-consuming, expensive, need advanced equipment facilities and trained personnel. The cost of diagnosis and the unavailability of sufficient test kits may prevent to check community transmission. Furthermore, expanding the testing facilities in asymptomatic cases in hotspots require more Point of Care (PoC) devices. Therefore, fast, inexpensive, and reliable methods of detection of SARS-nCoV-2 virus infection in humans is urgently required. The rapid and easy-to-use devices will facilitate onsite testing. In this review, nucleic acid assays, serological assays, multiplex assays, and PoC devices are discussed to understand various diagnostic approaches to reduce the spread and mortality rate in the future. Aptamer based detection is most specific, inexpensive and rapid detection of SARS-nCoV-2 without laboratory tools. To the best of our knowledge more than 900 SARS-nCoV-2 test kits are in pipeline, among 395 test kits are molecular bested test kits and only few test kits are developed using Aptamer technology https://www.finddx.org/covid-19/pipeline/.

Aspects of Point-of-Care Diagnostics for Personalized Health Wellness.

Advancements in analytical diagnostic systems for point-of-care (POC) application have gained considerable attention because of their rapid operation at the site required to manage severe diseases, even in a personalized manner. The POC diagnostic devices offer easy operation, fast analytical outcome, and affordable cost, which promote their advanced research and versatile adoptability. Keeping advantages in view, considerable efforts are being made to design and develop smart sensing components such as miniaturized transduction, interdigitated electrodes-based sensing chips, selective detection at low level, portable packaging, and sustainable durability to promote POC diagnostics according to the needs of patient care. Such effective diagnostics systems are in demand, which creates the challenge to make them more efficient in every aspect to generate a desired bio-informatic needed for better health access and management. Keeping advantages and scope in view, this mini review focuses on practical scenarios associated with miniaturized analytical diagnostic devices at POC application for targeted disease diagnostics smartly and efficiently. Moreover, advancements in technologies, such as smartphone-based operation, paper-based sensing assays, and lab-on-a-chip (LOC) which made POC more sensitive, informative, and suitable for major infectious disease diagnosis, are the main focus here. Besides, POC diagnostics based on automated patient sample integration with a sensing platform is continuously improving therapeutics interventions against specific infectious disease. This review also discussed challenges associated with state-of-the-art technology along with future research opportunities to design and develop next generation POC diagnostic systems needed to manage infectious diseases in a personalized manner.

Point-of-care biosensors in medicine: a brief overview of our achievements in this field based on the conducted research in EMRI (endocrinology and metabolism research Institute of Tehran University of medical sciences) over the past fourteen years.

The growing demand of diagnostic tools with enhanced analytical characteristics in term of sensitivity, selectivity, and low response time has encouraged researches to conduct their research towards development of point-of-care (POC) biosensors. POC diagnostic devices are powerful tools for detection, diagnosis, and monitoring of diseases at its initial stage. The above characteristics encouraged us to conduct active multidisciplinary and collaborative research oriented towards the design and development of POC sensing systems. Here, we present a brief overview of our recent achievement in the field of biomedical POC devices implemented in paper based microfluidic and screen printing electrodes and discuss the critical limitations that need to be surmounted to facilitate their translation into clinical practice in the future.