Girlich Delphine, Bernabeu Sandrine, Fortineau Nicolas, Dortet Laurent, Naas Thierry
EA7361 "Structure, Dynamic, Function and Expression of Broad Spectrum β-lactamases", Université Paris-Sud, Université Paris-Saclay, LabEx Lermit, Faculty of Medicine, Le Kremlin-Bicêtre, France; Evolution and Ecology of Resistance to Antibiotics Unit, Institut Pasteur - APHP -Université Paris-Sud, Paris, France.
EA7361 "Structure, Dynamic, Function and Expression of Broad Spectrum β-lactamases", Université Paris-Sud, Université Paris-Saclay, LabEx Lermit, Faculty of Medicine, Le Kremlin-Bicêtre, France; Evolution and Ecology of Resistance to Antibiotics Unit, Institut Pasteur - APHP -Université Paris-Sud, Paris, France; Bacteriology-Hygiene unit, Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital, Le Kremlin-Bicêtre, France.
Diagn Microbiol Infect Dis. 2018 Sep;92(1):1-7. doi: 10.1016/j.diagmicrobio.2018.02.001. Epub 2018 Feb 9.
As carbapenemase-producing Enterobacteriaceae (CPE) and extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) are becoming a major public health issue, there is an urgent need for accurate and fast diagnostic tests. The ELITe InGenius is a fully automated sample-to-result system designed for the extraction and detection by multiplex real-time polymerase chain reaction of carbapenemases KPC, NDM, VIM, IMP, and OXA-48-like variants and CTX-M group 1 and 9-producers from diverse sample matrices such as colonies, positive blood cultures, and rectal swabs. CRE and ESBL ELITe MGB® kits were evaluated on 153 cultured colonies of enterobacterial isolates with characterized β-lactamase content, on 30 spiked blood cultures, and the CRE kit was also evaluated on 53 clinical rectal swabs collected prospectively during a 3-month period and 10 spiked rectal swabs. CRE ELITe MGB® kit's performances reached 100% sensitivity and 100% specificity, while for the ESBL ELITe kit, 100% sensitivity and 96.6% specificity were observed, with a sample to result of less than 3 h and a total percentage of agreement with expected results of 99.6% (255/256).
由于产碳青霉烯酶肠杆菌科细菌（CPE）和产超广谱β-内酰胺酶肠杆菌科细菌（ESBL-E）正成为一个重大的公共卫生问题，因此迫切需要准确、快速的诊断检测方法。ELITe InGenius是一个全自动的从样本到结果的系统，旨在通过多重实时聚合酶链反应从各种样本基质（如菌落、阳性血培养物和直肠拭子）中提取和检测碳青霉烯酶KPC、NDM、VIM、IMP和OXA-48样变体以及CTX-M 1组和9组产生菌。对CRE和ESBL ELITe MGB®试剂盒进行了评估，评估对象包括153株具有特征性β-内酰胺酶含量的肠杆菌分离培养菌落、30份加标血培养物，CRE试剂盒还对3个月期间前瞻性收集的53份临床直肠拭子和10份加标直肠拭子进行了评估。CRE ELITe MGB®试剂盒的性能达到了100%的灵敏度和100%的特异性，而ESBL ELITe试剂盒的灵敏度为100%，特异性为96.6%，样本到结果的时间少于3小时，与预期结果的总一致率为99.6%（255/256）。
