Advancing prevention of sexually transmitted infections through point-of-care testing : target product profiles and landscape analysis

Objectives: Advancing the field of point-of-care testing (POCT) for STIs can rapidly and substantially improve STI control and prevention by providing targeted, essential STI services (case detection and screening). POCT enables definitive diagnosis and appropriate treatment in a single visit and home and community-based testing. Methods: Since 2014, the WHO Department of Reproductive Health and Research, in collaboration with technical partners, has completed four landscape analyses of promising diagnostics for use at or near the point of patient care to detect syphilis, Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis and the human papillomavirus. The analyses comprised a literature review and interviews. Two International Technical Consultations on STI POCTs (2014 and 2015) resulted in the development of target product profiles (TPP). Experts in STI microbiology, laboratory diagnostics, clinical management, public health and epidemiology participated in the consultations with representation from all WHO regions. Results: The landscape analysis identified diagnostic tests that are either available on the market, to be released in the near future or in the pipeline. The TPPs specify 28 analytical and operational characteristics of POCTs for use in different populations for surveillance, screening and case management. None of the tests that were identified in the landscape analysis met all of the targets of the TPPs. Conclusion: More efforts of the global health community are needed to accelerate access to affordable quality-assured STI POCTs, particularly in low-and middle-income countries, by supporting the development of new diagnostic platforms as well as strengthening the validation and implementation of existing diagnostics according to internationally endorsed standards and the best available evidence

The Multicorder: A Handheld Multimodal Metabolomics-on-CMOS Sensing Platform

The use of CMOS platforms in medical point-of-care applications, by integrating all steps from sample to data output, has the potential to reduce the diagnostic cost and the time from days to seconds. Here we present the `Multicorder' technology, a handheld versatile multimodal platform for rapid metabolites quantification. The current platform is composed of a cartridge, a reader and a graphic user interface. The sensing core of the cartridge is the CMOS chip which integrates a 16×16 array of multi-sensor elements. Each element is composed of two optical and one chemical sensor. The platform is therefore capable of performing multi-mode measurements: namely colorimetric, chemiluminescence, pH sensing and surface plasmon resonance. In addition to the reader that is employed for addressing, data digitization and transmission, a tablet computer performs data collection, visualization, analysis and storage. In this paper, we demonstrate colorimetric, chemiluminescence and pH sensing on the same platform by on-chip quantification of different metabolites in their physiological range. The platform we have developed has the potential to lead the way to a new generation of commercial devices in the footsteps of the current commercial glucometers for quick multi-metabolite quantification for both acute and chronic medicines

Smartphone-based food diagnostic technologies: A review

A new generation of mobile sensing approaches offers significant advantages over traditional platforms in terms of test speed, control, low cost, ease-of-operation, and data management, and requires minimal equipment and user involvement. The marriage of novel sensing technologies with cellphones enables the development of powerful lab-on-smartphone platforms for many important applications including medical diagnosis, environmental monitoring, and food safety analysis. This paper reviews the recent advancements and developments in the field of smartphone-based food diagnostic technologies, with an emphasis on custom modules to enhance smartphone sensing capabilities. These devices typically comprise multiple components such as detectors, sample processors, disposable chips, batteries and software, which are integrated with a commercial smartphone. One of the most important aspects of developing these systems is the integration of these components onto a compact and lightweight platform that requires minimal power. To date, researchers have demonstrated several promising approaches employing various sensing techniques and device configurations. We aim to provide a systematic classification according to the detection strategy, providing a critical discussion of strengths and weaknesses. We have also extended the analysis to the food scanning devices that are increasingly populating the Internet of Things (IoT) market, demonstrating how this field is indeed promising, as the research outputs are quickly capitalized on new start-up companies

From Chip-in-a-lab To Lab-on-a-chip: Towards A Single Handheld Electronic System For Multiple Application-specific Lab-on-a-chip (asloc)

We present a portable, battery-operated and application-specific lab-on-a-chip (ASLOC) system that can be easily configured for a wide range of lab-on-a-chip applications. It is based on multiplexed electrical current detection that serves as the sensing system. We demonstrate different configurations to perform most detection schemes currently in use in LOC systems, including some of the most advanced such as nanowire-based biosensing, surface plasmon resonance sensing, electrochemical detection and real-time PCR. The complete system is controlled by a single chip and the collected information is stored in situ, with the option of transferring the data to an external display by using a USB interface. In addition to providing a framework for truly portable real-life developments of LOC systems, we envisage that this system will have a significant impact on education, especially since it can easily demonstrate the benefits of integrated microanalytical systems. © the Partner Organisations 2014.141321682176Manz, A., Graber, N., Widmer, H.M., (1990) Sens. Actuators, B, 1, pp. 244-248Ríos, Á., Zougagh, M., Avila, M., (2012) Anal. Chim. Acta, 740, pp. 1-11Elvira, K.S., Solvas, X.C.I., Wootton, R.C.R., Demello, A.J., (2013) Nat. Chem., 5, pp. 905-915Nge, P.N., Rogers, C.I., Woolley, A.T., (2013) Chem. Rev., 113, pp. 2550-2583Kaushik, A., Vasudev, A., Arya, S.K., Pasha, S.K., Bhansali, S., (2014) Biosens. Bioelectron., 53, pp. 499-512Han, K.N., Li, C.A., Seong, G.H., (2013) Annu. Rev. Anal. Chem., 6, pp. 119-141Lee, J., Lee, S.-H., (2013) Biomed. Eng. Lett., 3, pp. 59-66Lewis, A.P., Cranny, A., Harris, N.R., Green, N.G., Wharton, J.A., Wood, R.J.K., Stokes, K.R., (2013) Meas. Sci. Technol., 24, p. 042001Yushan, Z., Jacquemod, C., Sawan, M., (2013) 2013 IEEE International Symposium on Circuits and Systems (ISCAS), , Beijing, China, 1071-1074Yang, J., Brooks, C., Estes, M.D., Hurth, C.M., Zenhausern, F., (2014) Forensic Sci. Int.: Genet., 8, pp. 147-158Czugala, M., Maher, D., Collins, F., Burger, R., Hopfgartner, F., Yang, Y., Zhaou, J., Diamond, D., (2013) RSC Adv., 3, pp. 15928-15938Legiret, F.-E., Sieben, V.J., Woodward, E.M.S., Abi Kaed Bey, S.K., Mowlem, M.C., Connelly, D.P., Achterberg, E.P., (2013) Talanta, 116, pp. 382-387Fernández-La-Villa, A., Sánchez-Barragán, D., Pozo-Ayuso, D.F., Castaño-Álvarez, M., (2012) Electrophoresis, 33, pp. 2733-2742Wang, S., Inci, F., Chaunzwa, T.L., Ramanujam, A., Vasudevan, A., Subramanian, S., Ip, A.C.F., Demirci, U., (2012) Int. J. Nanomed., 7, pp. 2591-2600Lillehoj, P.B., Huang, M.C., Ho, C.M., (2013) 2013 IEEE 26th International Conference on Micro Electro Mechanical Systems (MEMS), , Taipei, Taiwan, 53-56Ansari, K., Ying, J.Y.S., Hauser, P.C., De Rooij, N.F., Rodriguez, I., (2013) Electrophoresis, 34, pp. 1390-1399Toumazou, C., Shepherd, L.M., Reed, S.C., Chen, G.I., Patel, A., Garner, D.M., Wang, C.J., Zhang, L., (2013) Nat. Methods, 10, pp. 641-646Fintschenko, Y., (2011) Lab Chip, 11, pp. 3394-3400Hemling, M., Crooks, J.A., Oliver, P.M., Brenner, K., Gilbertson, J., Lisensky, G.C., Weibel, D.B., (2013) J. Chem. Educ., 91, pp. 112-115Yang, C.W., Lagally, E.T., (2013) Methods Mol. Biol., 949, pp. 25-40Priye, A., Hassan, Y.A., Ugaz, V.M., (2012) Lab Chip, 12, pp. 4946-4954Neuzil, P., Pipper, J., Hsieh, T.M., (2006) Mol. BioSyst., 2, pp. 292-298Neuzil, P., Zhang, C., Pipper, J., Oh, S., Zhuo, L., (2006) Nucleic Acids Res., 34, p. 77Novak, L., Neuzil, P., Pipper, J., Zhang, Y., Lee, S., (2007) Lab Chip, 7, pp. 27-29Pipper, J., Inoue, M., Ng, L.F., Neuzil, P., Zhang, Y., Novak, L., (2007) Nat. Med., 13, pp. 1259-1263Pipper, J., Zhang, Y., Neuzil, P., Hsieh, T.M., (2008) Angew. Chem., Int. Ed., 47, pp. 3900-3904Neuzil, P., Novak, L., Pipper, J., Lee, S., Ng, L.F., Zhang, C., (2010) Lab Chip, 10, pp. 2632-2634Neuzil, P., Reboud, J., (2008) Anal. Chem., 80, pp. 6100-6103Novak, L., Neuzil, P., Woon, J.S.B., Wee, Y., (2009) IEEE Sensors 2009 Conference, , Christchurch, New Zealand, 405-407Gaydos, C.A., Van Der Pol, B., Jett-Goheen, M., Barnes, M., Quinn, N., Clark, C., Daniel, G.E., Hook III, E.W., (2013) J. Clin. Microbiol., 51, pp. 1666-1672Neuzil, P., Wong, C.C., Reboud, J., (2010) Nano Lett., 10, pp. 1248-1252Cui, Y., Wei, Q., Park, H., Lieber, C.M., (2001) Science, 293, pp. 1289-1292Zhang, G.J., Luo, Z.H., Huang, M.J., Ang, J.J., Kang, T.G., Ji, H., (2011) Biosens. Bioelectron., 28, pp. 459-463Zhang, G.J., Zhang, G., Chua, J.H., Chee, R.E., Wong, E.H., Agarwal, A., Buddharaju, K.D., Balasubramanian, N., (2008) Nano Lett., 8, pp. 1066-1070Cumyn, V.K., Fleischauer, M.D., Hatchard, T.D., Dahn, J.R., (2003) Electrochem. Solid-State Lett., 6, pp. E15-E18Drake, K.F., Van Duyne, R.P., Bond, A.M., (1978) J. Electroanal. Chem., 89, pp. 231-24

Disposable sensors in diagnostics, food and environmental monitoring

Disposable sensors are low‐cost and easy‐to‐use sensing devices intended for short‐term or rapid single‐point measurements. The growing demand for fast, accessible, and reliable information in a vastly connected world makes disposable sensors increasingly important. The areas of application for such devices are numerous, ranging from pharmaceutical, agricultural, environmental, forensic, and food sciences to wearables and clinical diagnostics, especially in resource‐limited settings. The capabilities of disposable sensors can extend beyond measuring traditional physical quantities (for example, temperature or pressure); they can provide critical chemical and biological information (chemo‐ and biosensors) that can be digitized and made available to users and centralized/decentralized facilities for data storage, remotely. These features could pave the way for new classes of low‐cost systems for health, food, and environmental monitoring that can democratize sensing across the globe. Here, a brief insight into the materials and basics of sensors (methods of transduction, molecular recognition, and amplification) is provided followed by a comprehensive and critical overview of the disposable sensors currently used for medical diagnostics, food, and environmental analysis. Finally, views on how the field of disposable sensing devices will continue its evolution are discussed, including the future trends, challenges, and opportunities

Nucleic Acid-based Detection of Bacterial Pathogens Using Integrated Microfluidic Platform Systems

The advent of nucleic acid-based pathogen detection methods offers increased sensitivity and specificity over traditional microbiological techniques, driving the development of portable, integrated biosensors. The miniaturization and automation of integrated detection systems presents a significant advantage for rapid, portable field-based testing. In this review, we highlight current developments and directions in nucleic acid-based micro total analysis systems for the detection of bacterial pathogens. Recent progress in the miniaturization of microfluidic processing steps for cell capture, DNA extraction and purification, polymerase chain reaction, and product detection are detailed. Discussions include strategies and challenges for implementation of an integrated portable platform

Smartphone as a Portable Detector, Analytical Device, or Instrument Interface

The Encyclopedia Britannia defines a smartphone as a mobile telephone with a display screen, at the same time serves as a pocket watch, calendar, addresses book and calculator and uses its own operating system (OS). A smartphone is considered as a mobile telephone integrated to a handheld computer. As the market matured, solid-state computer memory and integrated circuits became less expensive over the following decade, smartphone became more computer-like, and more more-advanced services, and became ubiquitous with the introduction of mobile phone networks. The communication takes place for sending and receiving photographs, music, video clips, e-mails and more. The growing capabilities of handheld devices and transmission protocols have enabled a growing number of applications. The integration of camera, access Wi-Fi, payments, augmented reality or the global position system (GPS) are features that have been used for science because the users of smartphone have risen all over the world. This chapter deals with the importance of one of the most common communication channels, the smartphone and how it impregnates in the science. The technological characteristics of this device make it a useful tool in social sciences, medicine, chemistry, detections of contaminants, pesticides, drugs or others, like so detection of signals or image

Integrated Electrochemical Biosensors for Detection of Waterborne Pathogens in Low-Resource Settings

More than 783 million people worldwide are currently without access to clean and safe water. Approximately 1 in 5 cases of mortality due to waterborne diseases involve children, and over 1.5 million cases of waterborne disease occur every year. In the developing world, this makes waterborne diseases the second highest cause of mortality. Such cases of waterborne disease are thought to be caused by poor sanitation, water infrastructure, public knowledge, and lack of suitable water monitoring systems. Conventional laboratory-based techniques are inadequate for effective on-site water quality monitoring purposes. This is due to their need for excessive equipment, operational complexity, lack of affordability, and long sample collection to data analysis times. In this review, we discuss the conventional techniques used in modern-day water quality testing. We discuss the future challenges of water quality testing in the developing world and how conventional techniques fall short of these challenges. Finally, we discuss the development of electrochemical biosensors and current research on the integration of these devices with microfluidic components to develop truly integrated, portable, simple to use and cost-effective devices for use by local environmental agencies, NGOs, and local communities in low-resource settings

Electrochemical Plug-and-Power e-readers for Point-of-Care Applications

Point-of-Care diagnostic tests enable monitor health conditions and obtain fast results close to the patient, reducing medical costs, and allowing the control of infectious outbreaks. The interest in developing Point-of-Care devices is increasing due to they are suitable for a wide variety of applications. This doctoral thesis focuses on the development of Plug-and-Power electronic readers (e- readers) for electrochemical detections and the demonstration of their possibilities as Point-of-Care diagnostic testing. The solutions proposed in this study make it possible to improve Point-of-Care tests whose premises are laboratory decentralization, personalized medicine, rapid diagnosis, and improvement of patient care. Developed electronic readers can be powered from a conventional system, such as a USB port or a lithium battery, or can be defined as self-powered systems, capable of extracting energy from alternative energy sources, such as fuel cells, defining Plug-and-Power systems. The designed electrochemical detection devices in this thesis are based on low-power consumption electronic instrumentation circuits. These circuits are capable of controlling the sensing element, measuring its response, and representing the result quantitatively. The implemented devices can work with both electrochemical sensors and fuel cells. Furthermore, it is possible to adapt its measurement range, enabling its use in a wide variety of applications. Thanks to their reduced energy consumption, some of these developments can be defined as self-powered platforms able to operate only with the energy extracted from the biological sample, which in turn is monitored. These devices are easy-to-use and plug-and-play, enabling those unskilled individuals to carry out tests after prior training. Moreover, thanks to their user-friendly interface, results are clear and easy to understand. This doctoral dissertation is presented as an article compendium and composed of three publications detailed in chronological order of publication. The first contribution describes an innovative portable Point-of-Care device able to provide a quantitative result of the glucose concentration of a sample. The proposed system combines an e-reader and a disposable device based on two elements: a glucose paper-based power source, and a glucose fuel cell-based sensor. The battery-less e-reader extracts the energy from the disposable unit, acquires the signal, processes it, and shows the glucose concentration on a numerical display. Due to low-power consumption of the e-reader, the whole electronic system can operate only with the energy extracted from the disposable element. Furthermore, the proposed system minimizes the user interaction, which only must deposit the sample on the strip and wait a few seconds to see the test result. The second publication validates the e-reader in other scenarios following two approaches: using fuel cells as a power element, and as a dual powering and sensing element. The device was tested with glucose, urine, methanol, and ethanol fuel cells and electrochemical sensors in order to show the adaptability of this versatile concept to a wide variety of fields beyond clinical diagnostics, such as veterinary or environmental fields. The third study presents a low-cost, miniaturized, and customizable electronic reader for amperometric detections. The USB-powered portable device is composed of a full- custom electronic board for signal acquisition, and software, which controls the systems, represents and saves the results. In this study, the performance of the device was compared against three commercial potentiostats, showing comparable results to those obtained using three commercial systems, which were significantly more expensive. As proof of concept, the system was validated by detecting horseradish peroxidase samples. However, it could be easily extended its scope and measure other types of analytes or biological matrices since it can be easily adapted to detect currents a wide range of currents.Las pruebas de diagnostico Point-of-Care permiten monitorizar las condiciones de salud y obtener resultados rápidos cerca del paciente, reduciendo los costes médicos y permitiendo controlar brotes infecciosos. El interés por desarrollar dispositivos de Point- of-Care está aumentando debido a que son aplicables a una amplia variedad de aplicaciones. Esta tesis doctoral se centra en el desarrollo de lectores electrónicos (e-readers) Plug-and- Power para detecciones electroquímicas y la demostración de sus posibilidades como pruebas de diagnóstico de punto de atención (Point-of-Care). Las soluciones propuestas en este trabajo permiten mejorar las pruebas Point-of-Care, cuyas premisas son la descentralización de laboratorio, la medicina personalizada, el diagnóstico rápido y la mejora de la atención al paciente. Los lectores electrónicos desarrollados pueden ser alimentados desde un sistema convencional, como puede ser un puerto USB o una batería de litio, o definirse como sistemas autoalimentados, capaces de extraen energía de fuentes alternativas de energía, como celdas de combustible (fuel cells), definiendo así sistemas Plug-and-Power. Los dispositivos de detección electroquímica diseñados se basan en circuitos de instrumentación electrónica de bajo consumo. Estos circuitos son capaces controlar el elemento de sensado, medir su respuesta y representar el resultado de forma cuantitativa. Los dispositivos implementados pueden trabajar tanto con sensores electroquímicos como con fuel cells. Además, es posible adaptar su rango de medida, permitiendo su utilización en una amplia variedad de aplicaciones. Gracias a su reducido consumo de energía, algunos de estos desarrollos pueden definirse como plataformas autoalimentadas capaces de operar solo con la energía extraída de la muestra biológica, que a su vez es monitorizada. Estas plataformas electrónicas son fáciles de usar y Plug-and-Play, permitiendo que personas no cualificadas puedan utilizarlas después de un previo entrenamiento. Además, gracias a su interfaz fácil de usar, los resultados son claros y fáciles de interpretar