Leroy Anne-Gaëlle, Persyn Elise, Gibaud Sophie-Anne, Crémet Lise, Le Turnier Paul, Benhamida Myriam, Launay Elise, Guillouzouic Aurélie, Bémer Pascale, Corvec Stéphane
Department of Microbiology, University Hospital of Nantes, 44093 Nantes, France.
EA 3826 "Thérapeutiques Cliniques et Expérimentales des Infections", Institut de Recherche en Santé 2-Nantes Biotech, Medical University of Nantes, 44000 Nantes, France.
Microorganisms. 2021 Sep 1;9(9):1859. doi: 10.3390/microorganisms9091859.
Automated molecular panels are attractive tools for improving early meningitis diagnosis. This study assessed the Eazyplex CSF direct M panel (EP), a multiplex real-time Loop-Mediated Isothermal Amplification assay. From December 2016 to December 2019, cerebrospinal fluid (CSF) samples were routinely tested with the EP V1.0. CSF parameters and microbiological and clinical data were retrospectively collected. Out of 230 CSF samples, the EP yielded positive, negative, and invalid results for 32 (13.9%) (16 , nine , two , two , two , one ), 182 (79.1%), and 16 (7%) samples, respectively. Among the positive samples, 14 (44%) remained negative in culture (antibiotic therapy before lumbar puncture ( = 11), meningococcal meningitis ( = 3)). High CSF protein concentrations and cellularity were associated with LAMP inhibition, counteracted by centrifugation. The automated software yielded 13 false positive and five false negative results. Amplification curve analysis was necessary and enabled the attainment of positive (PPA) and negative percentage agreement and positive and negative predictive values of 91.4%, 100%, 100%, and 98.3%. Three false negative results remained (two and one ). presented the poorest PPA (50%). : This work confirms the strong performance of the EP, of particular interest in cases of antibiotic therapy before lumbar puncture.
自动化分子检测板是改善早期脑膜炎诊断的有吸引力的工具。本研究评估了Eazyplex脑脊液直接M检测板（EP），一种多重实时环介导等温扩增检测方法。从2016年12月到2019年12月，脑脊液（CSF）样本常规用EP V1.0进行检测。回顾性收集脑脊液参数以及微生物学和临床数据。在230份脑脊液样本中，EP分别对32份（13.9%）（16份、9份、2份、2份、2份、1份）样本得出阳性、阴性和无效结果，对182份（79.1%）样本得出阴性结果，对16份（7%）样本得出无效结果。在阳性样本中，14份（44%）培养结果仍为阴性（腰椎穿刺前接受抗生素治疗（n = 11），脑膜炎球菌性脑膜炎（n = 3））。高脑脊液蛋白浓度和细胞计数与环介导等温扩增抑制相关，通过离心可抵消。自动化软件得出13例假阳性和5例假阴性结果。扩增曲线分析是必要的，且能得出阳性百分一致性（PPA）、阴性百分一致性、阳性预测值和阴性预测值分别为91.4%、100%、100%和98.3%。仍有3例假阴性结果（2份 和1份 ）。 表现出最差的PPA（50%）。结论：这项工作证实了EP的强大性能，在腰椎穿刺前接受抗生素治疗的病例中尤其有意义。
