Current methods for monitoring specific molecules in the living body, such as the continuous glucose monitor, rely on the enzymatic or chemical reactivity of their targets, and thus are not generalizable to new targets. For this reason, only a handful of metabolites and neurotransmitters can currently be measured in vivo. Against this background, we are developing a molecular measurement platform that: (1) has been demonstrated able to work in the living body and (2) is independent of the reactivity of its targets and thus is general.Our devices use electrochemical aptamer-based (EAB) sensors. Aptamers are engineered nucleic acids generated by an in-vitro method to selectively bind desired molecular targets. The aptamers are designed to undergo a large-scale conformational change upon binding their target. By immobilizing one end of the aptamer to an interrogating electrode and modifying the other end with a redox reporter, target binding can be easily monitored using standard electrochemical techniques. Because every step in this process is rapidly reversible, EAB sensors can selectively monitor rising and falling target concentrations in vivo and in real time.

 A highly sensitive portable lab-on-a-chip (LOC) for cardiac troponin I (cTnI) detection was fabricated by the integration of a washing-free microfluidic system, antifouling interface, alternating current electrothermal (ACET) electrode, and electrochemical sandwich-type aptasensor. The microfluidic system was used for separating large particles from the blood sample and propelling the sample inside the detection zone without any external driving force. Mercaptohexanol (MCH) and bovine serum albumin (BSA) were deposited on the aptamer modified working electrode as an antifouling layer in order to prevent the gold surface from the non-specific reaction. The sample which consists of blood, biotinylated aptamer for troponin I (Ap-Tro6-biotin), streptavidin-horseradish peroxidase (SA-HRP), and phosphate-buffered saline (PBS) was then mixed with the hydrogen peroxide(H2O2) and hydroquinone (HQ) in the detection chamber with the assistance of ACET flow. Subsequently, cTnI-Ap-Tro6-biotin-SA-HRP conjugates in the sample were caught by a thiolated aptamer for troponin I (Ap-Tro4-SH) on a modified gold working electrode and formed a sandwich structure. Afterward, differential pulse voltammetry (DPV) was used to detect the redox reaction of the product, i.e., benzoquinone (BQ) from the H2O2 and HQ reaction that was accelerated by the catalytic ability of HRP. The greater cTnI concentration in the sample directly relates to the higher HRP concentration on the surface of the working electrode leading to the linear relationship between the logarithm of cTnI concentration and DPV reduction peak in the 0.1 to 100 pg/mL range. A limit of detection of 0.039 pg/mL is obtained in this study.

COVID-19 has spread globally since its discovery in China in December 2019, causing a growing demand for rapid and accurate diagnostic assays to enable mass screening and testing of both high-risk groups and normal population [1]. According to WHO, the current gold standard for the detection of SARS-CoV-2 is reverse transcription polymerase-chain reaction (RT- PCR), but has limitations, such as low specificity, long response time, expensive instruments, well-trained personnel and no point-of-care (POC) use [1-3]. Therefore, early, rapid and more sensitive detection methods of SARS-CoV-2 would represent a significant achievement to identify positive patients, allowing crucial decisions and public health strategies by healthcare providers and policy makers.  In this work, two proof-of-concept label-free electrochemical immunosensors for rapid SARS-CoV-2 detection via the spike protein have been developed. The platforms consist of a MWCNTs-screen-printed electrode (SPE) functionalized with electro-adsorbed methylene blue (MB) and bio-active layers of chitosan/protein A to enhance the bio-activity of the immobilized SARS-CoV-2 antibodies. Electrochemical characterization by cyclic voltammetry (CV) and electrochemical impedance spectroscopy (EIS) techniques evaluated the fabrication steps of the immunosensors. A change in mass and thickness on the electrode surface will be expected, due to the formation of the antibody-antigen complex, which blocks the electron transfer of the redox probe [(Fe(CN)₆ )]^3−/4−) to the electrode surface, causing a decrease of the current signal detected by differential pulse voltammetry (DPV), and an increase of the charge transfer resistance (Rct), detected by EIS. A comparison of the performances of the voltammetric and impedimetric-based immunosensors was reported. The proposed devices were successfully applied to the determination of the SARS-CoV-2 spike protein in saliva samples.

Neurodegenerative diseases are associated with progressive and irreversible loss of neurons in specific areas of the central nervous system (CNS). Multiple sclerosis (MS) is a recurrent and progressive inflammatory, demyelinating disease of the CNS. Nowadays, the number of MS patients is increasing, but the diagnostic process is still quite difficult and costly and requires combination of various methods and analysis. Myelin is a structure made up of a few proteins located between two lipid layers tightly wrapping the axons of neuro cells, which is necessary for rapid providing of electrical signal between CNS and body. Myelin basic protein (MBP) makes up to 30% of myelin and it is known to be released into the cerebrospinal fluid (CSF) as a bioindicator of MS ¹. In addition, in case of another demyelinating disease or trauma of CNS, MBP is present as a biomarker in human blood serum

Diabetes (diabetes), which is one of the leading diseases of the age, is a type of disease that plays the first role in the formation of many deadly diseases and is very common all over the world. Diagnosis of this disease requires precise determination of blood glucose concentration. Electrochemical biodetection is one of the most common methods used in recent years for the determination of glucose in various samples, including fruit juices, urine, blood serum. Inclusion of redox mediators in the design of glucose oxidase-based amperometric biosensors has become very popular. Moreover, utilization of nanofibers was found to be effective for improving the performance of most sensors thanks to their large surface area. The main purpose of this study is to examine the use of neutral red-doped polyacrylonitrile nanofibers (PAN-NR-NFs) as a suitable immobilization matrix on disposable screen-printed carbon electrodes for glucose detection in a sensitive and reliable manner. Compared to literature the biosensor revealed superior analytical performance especially in terms of LOD, where the sensitivity, detection limit and linear range of the developed biosensor was calculated to be 99.19 µA mM^-1 cm^-2, 0.068 µM and 0.01-0.6 mM, respectively. To test its commercial applicability, juice samples ensured from various brands were used as real samples where the calculated recovery values were close to 100%.

Telemedicine has been a gradually expanding field since its creation in 1968. However, the recent COVID-19 pandemic has accelerated the potential of applying the principles of remote consultations and diagnosis to a greater number of medical fields, including education, mental health, emergency medicine, and pediatrics. We briefly discuss the major organizations in the field of telemedicine, three major technological thrusts, as well as the benefits (wider reach, reduced costs, patient convenience) and challenges (legal standards, financial barriers, business strategies, human resources, IT security) of the field, also covering the current challenges in the Europe, Poland, and ather countries developing telemedicine policies may also face in the future.

In this invited Plenary presentation, I will talk about the research, development and commercialization of photonic integrated biosensors and their application for sensitive, rapid and multiplex detection of various analytes such as micro-organisms (viruses and bacteria) and biomarkers (proteins and DNA/RNA molecules). These biosensors can be applied in various application areas such as health care, e.g. for early diagnosis of cancer and heart diseases, food industry, e.g. for sensitive and fast detection of antibiotics in dairy products, national security, environmental monitoring, Pharma R&D, etc. The high sensitivity that photonic integrated biosensors can achieve could result to less sample pre-concentration handling, which contributes to faster analysis and savings on operational costs. Moreover, these biosensors are easy-to-use and compact, offering the possibility for development of portable/handheld devices. As such, photonic integrated biosensors are excellent candidates for fast and accurate analyte detection at the point-of-care settings such as airports, COVID-19 test streets, doctor’s offices or even at home.

Dye-decolorizing peroxidases (DyP) are heme-containing enzymes that couple the oxidation of different organic substrates, with the reduction of H₂O₂ to water. Due to their broad substrate range, easy genetic manipulation and over-expression in E. coli, as well as their stability over wide ranges of pH and temperature, DyPs are considered to be attractive targets for development of biotechnological applications¹. To that end, we explore DyPs from different bacterial organisms for construction of 3^rd generation H₂O₂ biosensors. We use surface enhanced Resonance Raman (SERRS) spectro-electrochemistry to probe structure and function of immobilized DyPs. The enzyme is attached to Ag electrodes coated with alkanethiol self-assembled monolayers (SAM) to ensure biocompatibility. The choice of SAM takes in consideration the surface charge distribution of each DyP. The structural properties of the enzymes in solution and immobilized state are addressed by RR and SERRS, respectively, while electrocatalytic properties are simultaneously analysed by electrochemistry.We have previously shown that DyP from Pseudomonas putida can be used as biocatalyst in an efficient 3^rd generation H₂O₂ biosensor, which reveals superior sensitivity in comparison to biosensors based on e.g. horseradish peroxidase². Optimized 3^rd generation DyP-based biosensors for H₂O₂ that show improved sensitivity, selectivity and stability are expected to be a valuable alternative to currently existing (commercial) devices that rely on other peroxidases. We therefore employ SERR spectro-electrochemistry to screen structural and redox properties of immobilized DyPs from different organisms in a fast manner, in the search for the best-behaved biocatalysts in terms of stability, sensitivity and selectivity.

 Biosensors are increasingly used as a powerful alternative to traditional analytical techniques for the simple, fast and accurate detection of a large number of parameters of interest in many fields such as food safety and quality analysis, environmental monitoring and health diagnostics, among others. Thanks to technological advances in electronics, nanomaterials, digitalization and connectivity, biosensors are becoming highly competitive tools with unique attributes such as speed, simplicity, easy of use, accuracy, cost and usability. In this context, BIOLAN is a group of companies focused on the development, large-scale production and commercialization of biosensors based on two main technologies that have proven to be highly effective for the simple, rapid and cost-effective detection of a large number of parameters on food and healthcare sectors: enzymatic biosensors based on electrochemical detection and lateral flow immunoassays

The SARS-CoV-2 virus pandemic has given an unparalleled escalating demand for accurate, low cost, biosensor systems for the early detection of the disease COVID-19. This has led to an unpredicted need for the availability of commercially mass-produced rapid diagnostics. The rapid community-spread of novel human coronavirus 2019 (nCOVID19 or SARS-Cov2) and morbidity statistics has put forth an unprecedented urge for rapid diagnostics for quick and sensitive detection followed by contact tracing and containment strategies, especially when no vaccine or therapeutics are known. The rapid community-spread of novel human coronavirus 2019 (nCOVID19 or SARS-Cov2) and morbidity statistics has put forth an unprecedented urge for rapid diagnostics for quick and sensitive detection followed by contact tracing and containment strategies, especially when no vaccine or therapeutics are known. While conventional technologies such as quantitative real-time polymerase chain reaction (PCR) are used to detect COVID-19, they are time-consuming, labour-intensive and are sparsely unavailable in remote settings. Point-of-care (POC) paper-based biosensors, such as lateral flow test strips or microfluidic biosensors are typically low-cost and user-friendly, are now being used for rapid diagnosis but since they are indicators do not always produce accurate results. These sensitive specific biosensors are used to detect antibodies, antigens or nucleic acids in samples of saliva, sputum and blood. followed by contact tracing and containment strategies, Biosensors can be applied for medical diagnosis of many other diseases, environmental monitoring, food, water, and agricultural product processing. They can be connected to smartphones and tablets to provide a quick personalised result to uses that save time and enables clinicians to spend it on seriously infected patients.

This paper looks at the opportunities for using sensors in the latest microphysiological systems(MPS) or Organs on a chip.Building such MPS is a truly multidisciplinary challenge requiring knowledge of biology, chemistry engineering and physics. Living cells are very complex entities and respond quickly to changes in their environment. Hence any long-term culture of cells needs an environment where pressure, partial oxygen pressure, flow stress and temperature must be carefully controlled and monitored. Otherwise the cells will differentiate away from the target phenotype and experimental results will be misleading and of little value in studying human disease or drug response. This talk will present situations where biosensors can support the development of better and more human relevant microphysiological systems.This represents an important and rapidly growing market opportunity to replace the use of animals.  The current use of animals for testing the safety and efficacy of chemicals and pharmaceuticals is misguided, unethical, wasteful from an economic point of view and outdated from a scientific perspective. The market for animal use is of the order of $30billion worldwide and estimated R&D spend is possibly 7% that equates to a budget of $210million being spent on the continuation of animal methods. If even a part of this can be directed towards in vitro MPS methods, it will create a massive growth in the current market for microtechnology used for in vitro testing of safety and efficacy of pharmaceuticals, cosmetics, food supplements and household chemicals.

Evolution has resulted in ‘products’ in nature that have properties that are of considerable interest to us.  A relatively new field called biomimetics (meaning ‘copying nature’) is taking advantage of nanotechnology developments.  It is early days but many research groups are now trying to harness certain characteristics of animals and plants, making use of senses that are better than ours.  Biosensors are being developed for enhanced detection of smells, sounds, sight and even feel.  This presentation summarises some of the more interesting applications that are being developed.  We can learn such a lot about biosensors, in this burgeoning field of biomimetics, from what has taken nature millennia to perfect.        

This talk will discuss how to commercialize new biosensor products. Launching medical devices and microfluidic diagnostic sensors will be addressed.  Biosensors must be biocompatible if used to test bodily fluids or to be implanted. Material selection impacts issues like sterilization, hemolysis, cytotoxicity, osmotic fragility, Partial Prothromboplastin Time (PTT) and Prothrombin Time (PT)  - clotting time. Regulatory approval concerns for new products must also be considered when launching a biosensor. These biospecific issues must be laid on top of traditional business development tasks such as fund raising, manufacturing, reliability, quality, packaging and documentation.  A systematic, stage-gate approach to commercializing biosensor products will be presented along with examples of prior sensor manufacturing technologies such as MEMS & additive manufacturing as well as, drug infusion, diagnostic and implant devices.

Academic and research institutions worldwide continue to receive significant government funding to support assay and biosensor development.  This funding has resulted in these institutions being able to build an assay and biosensor knowledge and intellectual property base.  In many instances, biosensor product concepts have been developed; however, not many products have been commercialized.  It is generally recognized that the conventional infrastructure of the educational system and of current manufacturing techniques are not supportive of the micro/nano-based product commercialization that is necessary to manufacture a biosensor product.    Developing this skill set for micro/nano manufacturing, particularly for engineers, is important for engineers to be proficient at designing biosensor products at the micro/nano scale.  Companies must be able to prototype design concepts and develop manufacturing processes to provide a pathway to biosensor commercialization.    The cost in time and financial resources to build the facilities and to provide the trained personnel and the equipment is beyond the reach of both small and large companies.  This paper will discuss the challenges within academia, industry, and government, and the need for coordinated roles in developing a commercialization pathway for micro/nano-based point of care biosensor products. The challenges will be demonstrated by examples of the commercial development of biomarkers/biosensors using saliva for detecting the progression of cancer, detection of cardiac diseases, and DNA/RNA biosensors for detection of COVID and other viral diseases.