Menchinelli Giulia, Squitieri Damiano, Magrì Carlotta, De Maio Flavio, D'Inzeo Tiziana, Cacaci Margherita, De Angelis Giulia, Sanguinetti Maurizio, Posteraro Brunella
Dipartimento di Scienze di Laboratorio ed Ematologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy.
Dipartimento di Scienze Biotecnologiche di Base, Cliniche Intensivologiche e Perioperatorie, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.
Antibiotics (Basel). 2024 Nov 7;13(11):1058. doi: 10.3390/antibiotics13111058.
: The International Organization for Standardization (ISO) 20776-2:2021, which replaces ISO 20776-2:2007, focuses solely on the performance of antimicrobial susceptibility testing (AST) assays, emphasizing the ISO 20776-1 broth microdilution method as the reference standard. Consequently, categorical agreement (CA) and associated errors should not be applied. We verified the Vitek Reveal AST assay according to both ISO 20776-2:2021 and ISO 20776-2:2007 criteria. : Samples from 100 simulated and clinical Gram-negative (GN) positive blood cultures (PBCs) were tested at a large teaching hospital. The simulated GN-PBCs were obtained from a hospital collection of isolates selected to represent diverse antimicrobial resistance profiles. The Reveal assay results were compared with those from the reference assay, and the time to result (TTR) for the Reveal assay was calculated. : The essential agreement rates were 96.1% (816/849) for simulated and 98.8% (929/940) for clinical GN-PBC samples. The bias values were -3.1 for simulated and -11.0 for clinical samples. The CA rates were 97.7% (808/827) for simulated and 99.2% (924/931) for clinical samples. The mean TTR ± SD (hours) for resistant organisms was significantly lower (4.40 ± 1.15) than that for susceptible, increased exposure (5.52 ± 0.48) and susceptible (5.54 ± 0.49) organisms. : Our findings reinforce the potential of the Reveal assay as a valuable tool and support its implementation in clinical microbiology laboratories.
国际标准化组织（ISO）20776-2:2021取代了ISO 20776-2:2007，仅关注抗菌药物敏感性试验（AST）检测的性能，强调将ISO 20776-1肉汤微量稀释法作为参考标准。因此，不应应用类别一致性（CA）及相关误差。我们根据ISO 20776-2:2021和ISO 20776-2:2007标准对Vitek Reveal AST检测进行了验证。：在一家大型教学医院对100份模拟和临床革兰氏阴性（GN）阳性血培养（PBC）样本进行了检测。模拟GN-PBC样本取自医院收集的分离株，这些分离株被选来代表不同的抗菌药物耐药谱。将Reveal检测结果与参考检测结果进行比较，并计算Reveal检测的报告结果时间（TTR）。：模拟GN-PBC样本的基本一致率为96.1%（816/849），临床样本为98.8%（929/940）。模拟样本的偏差值为-3.1，临床样本为-11.0。模拟样本的CA率为97.7%（808/827），临床样本为99.2%（924/931）。耐药菌的平均TTR±标准差（小时）显著低于敏感菌、延长暴露菌（5.52±0.48）和敏感菌（5.54±0.49）（4.40±1.15）。：我们的研究结果强化了Reveal检测作为一种有价值工具的潜力，并支持其在临床微生物实验室中的应用。
