Enigma Diagnostics Ltd announces that it has successfully completed analytical and diagnostic verification of its FluAB-RSV diagnostic assay on the Enigma® ML system at Guy's and St Thomas' NHS Foundation Trust, and will conclude clinical validation and CE marking of the test in 2013.
Enigma has installed a number of mini laboratory (ML) instruments at Guy's and St. Thomas' for use at the Trust's Centre for Clinical Infection and Diagnostics Research (CIDR). During May and June 2013, several hundred clinical samples, obtained by Enigma from patients in Africa with symptoms of respiratory disease, were processed on the Enigma® ML system and compared with data from the Luminex xTAG respiratory viral panel, showing comparable sensitivity and specificity between the two systems. The Enigma® ML achieved negative predictive value (NPV) and positive predictive value (PPV) values of 100% for the FluB and respiratory syncytial virus (RSV) components of the assay and NPV and PPV of 97% and 100% for the FluA component of the assay.
The Enigma®ML system has the capability to deliver PCR-based results from a raw sample in about 60 minutes and Enigma, in addition to the FluAB-RSV test, is developing a series of deeply multiplexed assays for the Enigma® ML including panel tests for respiratory viruses, multi-drug resistant tuberculosis and other respiratory infections.
John McKinley, Chairman of Enigma Diagnostics, said: "We are delighted to be collaborating with such a prestigious and influential clinical centre. Having achieved such an exceptional diagnostic performance on our Enigma® ML system with the FluAB-RSV assay, we are now ready for validation and CE marking."
Dr Jonathan Edgeworth, Consultant Microbiologist and Head of the Centre for Clinical Infection and Diagnostics Research, said: "We are pleased that Enigma has chosen Guy's and St. Thomas' as its partner to test the performance of the Enigma® ML system. This will provide an opportunity to influence the development of a testing system that has potential to benefit patients in the future.