Point-of-care, polymerase chain reaction (PCR) system for diagnosis and surveillance of influenza
Session III – Weinberger, Paul
Title of Contribution: Point-of-care, polymerase chain reaction (PCR) system for diagnosis and surveillance of influenza
Author(s): Weinberger, Paul; Lee, Martin Ph.D
Affiliation(s): Enigma Diagnostics Ltd
Abstract:
Enigma Diagnostics is the leader of a European Commission Framework 7 project, known as RANGER, developing a fully-automated, real-time PCR system which will enable:
1) Rapid diagnosis of influenza (both seasonal and pandemic) in the point-of-care environment enabling faster and better informed medical care to reduce suffering and save lives
2) Co-ordinated surveillance of influenza incidents and outbreaks ,enabling rapid deployment of resources to control disease spread and treat patients
The RANGER international consortium is made up of both commercial and not-for-profit partners, including The Queen Sirikit National Institute for Child Health (Thailand) and the Health Protection Agency (UK). The consortium brings together experts in the fields of: influenza diagnosis and surveillance; sample preparation; PCR; in vitro diagnostics system development; engineering; materials science; lyophilisation; surveillance monitoring software.
The primary objective of the project is the development of the Enigma ML instrument. During the initial phase we collected substantial feedback from end users and stakeholders in the project, including clinicians, laboratory professionals and representatives of the World Health Organisation, in order to verify the system design. The results of this research have contributed to the specifications of both the hardware and assays.
The ML will be a multi-station, random-access diagnostics platform developed for operation by non-laboratory staff in the near-patient-testing environment. It will perform fully automated sample extraction, fluorogenic PCR and analysis in less than 40 minutes. The platform will have a small footprint, flexible architecture and the connectivity for diverse deployment across the healthcare setting. The system will handle multiple swabs from the respiratory tract, which are placed into a conventional transport tube before loading into the ML cartridge. The cartridge will be a single-use, consumable device which carries all materials required to carry out the sample preparation and thermal cycling processes.
The ML transfers core technologies from the first generation FL instrument, which has recently been introduced for rapid identification of avian influenza in animals. Significant progress has been made on the development of the ML system, with working bench-top rigs now available and demonstrating feasibility. Here we discuss voice of customer work in the clinical community to establish user requirements & assay specifications, the development approach and progress to-date, future plans and applications of the ML system.
