Q-linea AB, Uppsala, Sweden.
Department of Laboratory Medicine, Clinical Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
J Clin Microbiol. 2023 Mar 23;61(3):e0152522. doi: 10.1128/jcm.01525-22. Epub 2023 Feb 28.
The rapid administration of optimal antimicrobial treatment is paramount for the treatment of bloodstream infections (BSIs), and rapid antimicrobial susceptibility testing (AST) results are essential. Q-linea has developed the ASTar system, a rapid phenotypic AST device. Here, we report the performance of the ASTar BC G- (Gram-negative) kit when assessed according to the ISO 20776-2:2007 standard for performance evaluation of diagnostic AST devices. The evaluated ASTar BC G- kit uses a broad panel of 23 antimicrobials for the treatment of BSIs caused by Gram-negative fastidious and nonfastidious bacteria across a range of 6 to 14 2-fold dilutions, including cefoxitin as a screening agent for AmpC-producing . The ASTar system processes blood culture samples to generate data on MICs and susceptible, intermediate, or resistant (SIR) category. The automated protocol includes concentration determination and concentration adjustment to enable a controlled inoculum, followed by broth microdilution (BMD) and microscopy performed continuously to generate MIC values within approximately 6 h once the test is run on the ASTar system. The performance of the ASTar system was assessed against the ISO 20776-2:2007 standard BMD reference method. Testing was performed across three sites, with results from 412 contrived blood cultures and 74 fresh clinical blood cultures. The ASTar system was also tested for reproducibility, with triplicate testing of 11 strains. The accuracy study comprised 8,650 data points of bacterium-antimicrobial tests. The ASTar system demonstrated an overall essential agreement (EA) of 95.8% (8,283/8,650) and a categorical agreement (CA) of 97.6% (8,433/8,639) compared to the reference BMD method. The overall rate of major discrepancies (MDs) was 0.9% (62/6,845), and that of very major discrepancies (VMDs) was 2.4% (30/1,239). This study shows that the ASTar system delivers reproducible results with overall EA and CA of >95%.
快速给予最佳抗菌治疗对于治疗血流感染（BSI）至关重要，而快速抗菌药敏试验（AST）结果是必不可少的。Q-linea 开发了 ASTar 系统，这是一种快速表型 AST 设备。在这里，我们根据 ISO 20776-2：2007 标准报告 ASTar BC G-（革兰氏阴性）试剂盒的性能评估，用于诊断 AST 设备的性能评估。评估的 ASTar BC G-试剂盒使用一个广泛的 23 种抗生素板，用于治疗革兰氏阴性苛养和非苛养细菌引起的 BSI，范围从 6 到 14 倍稀释，包括头孢西丁作为 AmpC 产生的筛选剂。ASTar 系统处理血培养样本，生成 MIC 和敏感、中介或耐药（SIR）类别数据。自动化方案包括浓度测定和浓度调整，以实现受控接种物，然后进行肉汤微量稀释（BMD）和连续显微镜检查，一旦在 ASTar 系统上运行测试，大约 6 小时内即可生成 MIC 值。ASTar 系统的性能根据 ISO 20776-2：2007 标准 BMD 参考方法进行评估。在三个地点进行了测试，结果来自 412 个人工血培养物和 74 个新鲜临床血培养物。ASTar 系统还进行了重复性测试，对 11 株进行了三次重复测试。准确性研究包括 8650 个细菌-抗生素测试数据点。ASTar 系统与参考 BMD 方法相比，总体基本符合率（EA）为 95.8%（8283/8650），分类符合率（CA）为 97.6%（8433/8639）。总体主要差异（MD）率为 0.9%（62/6845），非常大差异（VMD）率为 2.4%（30/1239）。这项研究表明，ASTar 系统具有可重复性，总体 EA 和 CA 均超过 95%。
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