Nucleic Acid Testing (NAT) promises rapid, sensitive and specific diagnosis of infectious, inherited and genetic disease. The next generation of diagnostic devices will interrogate the genetic determinants of such conditions at the point-of-care, affording clinicians prompt reliable diagnosis from which to guide more effective treatment. The complex biochemical nature of clinical samples, the low abundance of nucleic acid targets in the majority of clinical samples and existing biosensor technology indicate that some form of nucleic acid amplification will be required to obtain clinically relevant sensitivities from the small samples used in point-of-care testing (POCT). This publication provides an overview and thorough review of existing technologies for nucleic acid amplification. The different methods are compared and their suitability for POCT adaptation are discussed. Current commercial products employing isothermal amplification strategies are also investigated. In conclusion we identify the factors impeding the integration of the methods discussed in fully automated, sample-to-answer POCT devices.

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Until vaccines and effective therapeutics become available, the practical solution to transit safely out of the current coronavirus disease 19 (CoVID-19) lockdown may include the implementation of an effective testing, tracing and tracking system. However, this requires a reliable and clinically validated diagnostic platform for the sensitive and specific identification of SARS-CoV-2. Here, we report on the development of a de novo, high-resolution and comparative genomics guided reverse-transcribed loop-mediated isothermal amplification (LAMP) assay. To further enhance the assay performance and to remove any subjectivity associated with operator interpretation of results, we engineered a novel hand-held smart diagnostic device. The robust diagnostic device was further furnished with automated image acquisition and processing algorithms and the collated data was processed through artificial intelligence (AI) pipelines to further reduce the assay run time and the subjectivity of the colorimetric LAMP detection. This advanced AI algorithm-implemented LAMP (ai-LAMP) assay, targeting the RNA-dependent RNA polymerase gene, showed high analytical sensitivity and specificity for SARS-CoV-2. A total of ~200 coronavirus disease (CoVID-19)-suspected NHS patient samples were tested using the platform and it was shown to be reliable, highly specific and significantly more sensitive than the current gold standard qRT-PCR. Therefore, this system could provide an efficient and cost-effective platform to detect SARS-CoV-2 in resource-limited laboratories.

Continuous and reliable measurements of core body temperature (CBT) are vital for studies on human thermoregulation. Because tympanic membrane directly reflects the temperature of the carotid artery, it is an accurate and non-invasive method to record CBT. However, commercial tympanic thermometers lack portability and continuous measurements. In this study, graphene inks were utilized to increase the accuracy of the temperature measurements from the ear by coating graphene platelets on the lens of an infrared thermopile sensor. The proposed ear-based device was designed by investigating ear canal geometry and developed with 3D printing technology using the Computer-Aided Design (CAD) Software, SolidWorks 2016. It employs an Arduino Pro Mini and a Bluetooth module. The proposed system runs with a 3.7 V, 850 mAh rechargeable lithium-polymer battery that allows long-term, continuous monitoring. Raw data are continuously and wirelessly plotted on a mobile phone app. The test was performed on 10 subjects under resting and exercising in a total period of 25 min. Achieved results were compared with the commercially available Braun Thermoscan, Original Thermopile, and Cosinuss One ear thermometers. It is also comprehended that such system will be useful in personalized medicine as wearable in-ear device with wireless connectivity.