Enigma Diagnostics Ltd has successfully finished 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.