Koeth L M, DiFranco-Fisher J M, Palavecino E, Kilic A, Hardy D, Vicino D, Stracquadanio S, Stefani S
Laboratory Specialists, Inc., Westlake, Ohio, USA.
School of Medicine, Wake Forest University, Winston-Salem, North Carolina, USA.
J Clin Microbiol. 2025 Feb 19;63(2):e0092624. doi: 10.1128/jcm.00926-24. Epub 2024 Dec 31.
The performance of the Liofilchem Compact Antimicrobial Susceptibility Panel (ComASP) Cefiderocol was evaluated in a multicenter study. Enterobacterales, , and clinical isolates and challenge isolates were tested by three and one sites, respectively. Minimum inhibitory concentration (MIC) testing was performed by the Clinical and Laboratory Standards Institute (CLSI) broth microdilution and ComASP, which included two reading endpoints (CLSI read; MIC is the first well in which reduction of growth is <1 mm or light haze/faint turbidity] and ComASP [ComASP read; MIC is the first well at which 100% inhibition of growth occurs]). Each site performed reproducibility and quality control (QC) by ComASP and broth microdilution (BMD). Reproducibility was excellent (97.4% within ±1 dilution of modal MIC). All QC results were within CLSI QC ranges by BMD and ComASP, except for two ATCC 25922 results from one site. Essential agreement for combined clinical and challenge Enterobacterales was 84.3% (CLSI read) and 95.7% (ComASP read), was 83.3% (CLSI read) and 93.7% (ComASP read), and was 78.3% (CLSI read) and 96.7% (ComASP read). Categorical agreement for Enterobacterales was 92.4% for both CLSI read and ComASP read, for was 89.7% (CLSI read) and 92.1% (ComASP read), and for was 72.8% (CLSI read) and 91.3% (ComASP read). There were no very major errors using the ComASP read. One very major error for occurred using the CLSI read method. Three very major errors for occurred using the CLSI read method. ComASP Cefiderocol was shown to be a reliable method for testing cefiderocol MIC against relevant clinical isolates when ComASP read is used.
There are very limited commercial methods available to clinical laboratories for cefiderocol minimum inhibitory concentration (MIC) testing. The Compact Antimicrobial Susceptibility Panel (ComASP) Cefiderocol method includes iron-depleted cation-adjusted Mueller-Hinton broth, which eliminates variability in cefiderocol MIC results based on iron levels. The lyophilized multi-well format of ComASP also provides for room temperature storage. In comparison to what an individual lab may do for method verification, this multi-site, multi-isolate study provides a robust evaluation and greater assurance to clinical microbiologists of the method's accurate and reproducible performance.
在一项多中心研究中评估了利奥菲化学紧凑型抗菌药物敏感性检测板（ComASP）头孢地尔的性能。分别在三个和一个地点对肠杆菌科细菌、[此处原文缺失部分内容]以及临床分离株和挑战分离株进行了检测。通过临床和实验室标准协会（CLSI）肉汤微量稀释法和ComASP进行最低抑菌浓度（MIC）检测，ComASP包括两个读数终点（CLSI读数；MIC是生长减少<1毫米或轻度浑浊/微弱浊度的第一个孔）和ComASP（ComASP读数；MIC是生长100%被抑制的第一个孔）。每个地点通过ComASP和肉汤微量稀释法（BMD）进行重复性和质量控制（QC）。重复性极佳（在模式MIC的±1稀释范围内为97.4%）。除了一个地点的两个ATCC 25922结果外，所有QC结果通过BMD和ComASP均在CLSI QC范围内。临床和挑战肠杆菌科细菌组合的基本一致性在CLSI读数时为84.3%，在ComASP读数时为95.7%；[此处原文缺失部分内容]在CLSI读数时为83.3%，在ComASP读数时为93.7%；[此处原文缺失部分内容]在CLSI读数时为78.3%，在ComASP读数时为96.7%。肠杆菌科细菌的分类一致性在CLSI读数和ComASP读数时均为92.4%，[此处原文缺失部分内容]在CLSI读数时为89.7%，在ComASP读数时为92.1%；[此处原文缺失部分内容]在CLSI读数时为72.8%，在ComASP读数时为91.3%。使用ComASP读数没有非常重大的错误。使用CLSI读数方法时，[此处原文缺失部分内容]出现了一个非常重大的错误。使用CLSI读数方法时，[此处原文缺失部分内容]出现了三个非常重大的错误。当使用ComASP读数时，ComASP头孢地尔被证明是针对相关临床分离株检测头孢地尔MIC的可靠方法。
临床实验室可用于头孢地尔最低抑菌浓度（MIC）检测的商业方法非常有限。紧凑型抗菌药物敏感性检测板（ComASP）头孢地尔方法包括缺铁阳离子调整的穆勒-欣顿肉汤，可消除基于铁水平的头孢地尔MIC结果的变异性。ComASP的冻干多孔形式还便于在室温下储存。与单个实验室可能进行的方法验证相比，这项多地点、多分离株研究为临床微生物学家提供了对该方法准确和可重复性能的有力评估和更大保证。
