P07.03 Clinical performance evaluation of a new, rapid point-of-care system for detectingchlamydia trachomatis

Abstract

Introduction The Atlas Genetics io ™ system is a new rapid molecular diagnostic platform designed to test for infectious diseases at Point of Care (POC). The test process is fully automated and utilises a novel nucleic acid detection technology. There is no specimen processing and it provides a result in 30 min. This preliminary evaluation compared the performance of the Atlas Genetics io ™ Chlamydia trachomatis (CT) test to routine diagnostic testing using the APTIMA Combo 2 test (AC2, Hologic Gen-Probe) for the detection of CT. Methods Two self-collected vulvo-vaginal swabs were obtained from women presenting at a genitourinary medicine clinic; swabs from alternate patients were placed in collection buffer and tested using the AC2 test or the io ™ CT assay as the first test. Any sample giving a discrepant result was retested using the residual buffer from the io ™ CT assay using the artus ® C. trachomatis Plus RG PCR kit (Qiagen). A true positive result was defined as positive with at least two of the three tests. Results Of the samples collected from 193 women, 18 were determined to be true positive results for C. trachomatis , of which one sample was positive with the AC2 and artus CT test but negative with the io ™ CT test. Three io TM false positive results were reported out of 175 samples that were negative when tested using the AC2 and artus tests. Based on a provisional cut-off, this resulted in a sensitivity and specificity of 94.4% and 98.3%, respectively for the io ™ CT test. Conclusion The Atlas Genetics io ™ CT test was shown to deliver laboratory-equivalent results within 30 min, on a system designed to be used in the STI clinic or similar POC setting, that is easy-to-use and gives results that require no interpretation or analysis. Disclosure of interest statement BA, SAB, TRKE, MTG and DMP receive salaries and stock options from Atlas Genetics Ltd. This study was funded by the Technology Strategy Board, project No. 100845.