Tanja Holma1, Jenni Antikainen1, Johanna Haiko2. 1. Helsinki University and Helsinki University Hospital, HUSLAB, Department of Clinical Microbiology, Helsinki, Finland. 2. Helsinki University and Helsinki University Hospital, HUSLAB, Department of Clinical Microbiology, Helsinki, Finland. Electronic address: johanna.haiko@hus.fi.
Abstract
BACKGROUND: Carbapenemase-producing Gram-negative bacilli, i.e., Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter, are of increased concern for the public health around the world. There is urgent need for rapid and accurate tests in order to provide correct treatment and to prevent bacterial spread in healthcare settings. METHODS: The aim of this study was to evaluate three commercial multiplex carbapenemase tests with CE-IVD marking: Eazyplex SuperBug complete B (AmplexDiagnostics), Novodiag CarbaR+ (Mobidiag), and Amplidiag CarbaR+MCR (Mobidiag). All these tests recognize KPC, NDM, OXA-48/181 group, VIM, OXA-23 group, and OXA-24/40 group, and Novodiag CarbaR+ and Amplidiag CarbaR+MCR additionally recognize IMP, OXA-51 group (with promoter located within ISAbaI), OXA-58 group, and MCR, and Amplidiag CarbaR+MCR further recognizes GES (carbapenemase-type only). RESULTS: The sensitivities and specificities of these tests with bacterial isolates were 100%. The sensitivity directly from clinical samples was 100%, but the specificity was lower, which is simply explained by the higher sensitivity of the molecular methods compared with culture method. CONCLUSIONS: Overall, these CE-IVD marked tests provide a good alternative in the detection of carbapenemase-producing organisms.
BACKGROUND: Carbapenemase-producing Gram-negative bacilli, i.e., Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter, are of increased concern for the public health around the world. There is urgent need for rapid and accurate tests in order to provide correct treatment and to prevent bacterial spread in healthcare settings. METHODS: The aim of this study was to evaluate three commercial multiplex carbapenemase tests with CE-IVD marking: Eazyplex SuperBug complete B (AmplexDiagnostics), Novodiag CarbaR+ (Mobidiag), and Amplidiag CarbaR+MCR (Mobidiag). All these tests recognize KPC, NDM, OXA-48/181 group, VIM, OXA-23 group, and OXA-24/40 group, and Novodiag CarbaR+ and Amplidiag CarbaR+MCR additionally recognize IMP, OXA-51 group (with promoter located within ISAbaI), OXA-58 group, and MCR, and Amplidiag CarbaR+MCR further recognizes GES (carbapenemase-type only). RESULTS: The sensitivities and specificities of these tests with bacterial isolates were 100%. The sensitivity directly from clinical samples was 100%, but the specificity was lower, which is simply explained by the higher sensitivity of the molecular methods compared with culture method. CONCLUSIONS: Overall, these CE-IVD marked tests provide a good alternative in the detection of carbapenemase-producing organisms.
Authors: Aurore C Poirier; Dai Kuang; Bianca S Siedler; Khushboo Borah; Jai W Mehat; Jialin Liu; Cui Tai; Xiaoli Wang; Arnoud H M van Vliet; Wei Ma; David R Jenkins; John Clark; Roberto M La Ragione; Jieming Qu; Johnjoe McFadden Journal: Front Mol Biosci Date: 2022-02-09