At Patient Testing (APT) represents a paradigm shift in molecular diagnostics. This novel, technology led actionable strategy focuses on testing whilst the patient (human or animal) waits in a decentralised environment (no specialist lab facilities or infrastructure required) by users with minimal training.
Patients can be rapidly diagnosed with the sensitivity to enable the early detection of subclinical, asymptomatic and non-symptomatic cases. This unique strategy provides actionable results and data in ‘real time’ to assist in triaging, treatment, and surveillance activities to help break onward disease transmission chains and mitigate the effects of High Consequence Infectious Diseases (HCIDs) on society.
Everything we do and our continuous research into new innovations is dedicated to supporting At Patient Testing. APT represents true point of care testing in any environment without frontiers.
The current molecular diagnostics landscape is fraught with challenges and an ever pressing threat of emerging High Consequence Infectious Diseases (HCIDs). The global inability and lack of preparedness in responding to these infectious diseases was highlighted during the COVID-19 pandemic. However this further clarified the following challenges facing molecular diagnostics and the lessons to be learnt:
Pandemic preparedness through proactive surveillance and monitoring is the key to identifying and containing emerging diseases before they have a chance to escalate into epidemics and ultimately pandemics. Most novel diseases likely circulate for some time in animals and humans before they’re eventually detected in clinical cases.
This crucial period of opportunity is the early stage when diseases need to be identified. For this to be achieved testing efforts have to be rapidly deployed and established early to focus on isolating the source of infection in-country at the point of origin wherever that may be. For too long, we have allowed a cycle of panic and neglect when it comes to pandemics: we ramp up efforts when there’s a serious threat, then quickly forget about them once the threat appears to subside. This reactive mindset needs to be replaced with a proactive one, to ensure we are one step ahead of the next emerging disease and fully prepared.
The early detection, quarantine and containment of emerging pathogens is integral to prevent infectious diseases from establishing and spreading globally. Current testing methods require patient samples to be collected and sent to a centralized laboratory which often carries a lead-time of several days. In this time whilst waiting for the results potentially infected patients are free to travel, transmit and spread the disease to others.
Early detection and containment is only possible with platforms that possess the necessary sensitivity and speed to accurately detect subclinical, asymptomatic or non-symptomatic cases whilst the patient waits. This capability is currently unfulfilled in molecular diagnostics and is a vulnerable chink in the armour of the worlds biodefence. Lateral Flow Testing (LFT) is commonly used to inexpensively screen populations on a large scale but severely lacks the sensitivity and accuracy to effectively deliver results. Patients are required to have an extremely high viral load for LFT devices to detect the target by which time they have already spread the disease throughout the population. Poor accuracy also results in a high frequency of both false negatives and positives.
Currently the only option for deploying RT-qPCR diagnostics outside of centralized lab facilities is in the form of near patient testing platforms. However these platforms require accompanying field laboratories, specialist personnel and dedicated equipment. The platform itself does not represent true portability and relies instead on also moving the laboratory, personnel and equipment required so it can be operated in a semi-decentralized setting. This attempt of portability is not adequate and needs to be addressed by an effective platform which is truly portable and capable of being independently deployed anywhere in the world in any environment.
Many current platform offerings use complex cartridge based consumables and require specialist personnel to operate them and process samples. This makes it prohibitively expensive for screening large numbers and makes testing inaccessible to the majority of populations, in particular Low and Middle Income Countries (LMICs) who already suffer from an array of Viral Haemorrhagic Fevers (VHFs) and is often where High Consequence Infectious Diseases (HCIDs) originate from.
At Patient Testing (APT) is part of the solution to address current challenges faced in molecular diagnostics. The goal of APT is to make possible the rapid deployment of RT-qPCR diagnostic testing into any usage environment (both centralised and decentralised settings) whilst the patient waits providing actionable results in real time. If used holistically together with other approaches such as Lateral Flow Devices, lab-based screening and vaccination programmes APT will significantly improve global health outcomes – but most importantly save lives.
Rapid Deployment Anywhere: in the event of an emerging outbreak APT allows testing efforts to be rapidly deployed and established early on to focus on proactively isolating the source of infection in-country at the point of origin and prevent any further dissemination into other areas. True portability means testing efforts can be effectively established at ports of entry, rural clinics or community centres, forward operating bases, in-field and wherever else it may be required without limitation.
Molecular Diagnostics Accessible to All: the approach is simple, low cost and robust with no requirements for specialist personnel, facilities, equipment or sample processing. This makes it accessible to all populations, including resource poor environments often representative of Low and Middle Income Countries (LMICs). Populations will also be more proactive and receptive to testing efforts if they can easily access localised testing in their community rather than having to travel to centralised testing facilities.
Early Detection & Containment: the patient (human or animal) waits whilst the test is being run which is completed in under 30 minutes and has the required sensitivity to detect subclinical, asymptomatic and non-symptomatic cases. This unique approach provides actionable results and data in ‘real time’ to assist in triaging, treatment and surveillance activities to help break onward disease transmission chains and mitigate the effects of High Consequence Infectious Diseases (HCIDs) on society.