Henry Ford Health Systemgrid.239864.2, Division of Clinical Microbiology, Detroit, Michigan, USA.
Specific Diagnostics, Mountain View, California, USA.
J Clin Microbiol. 2022 Jun 15;60(6):e0009822. doi: 10.1128/jcm.00098-22. Epub 2022 May 24.
Timely and effective antibiotic treatment is vital for sepsis, with increasing incidence of antimicrobial-resistant bacteremia driving interest in rapid phenotypic susceptibility testing. To enable the widespread adoption needed to make an impact, antibiotic susceptibility testing (AST) systems need to be accurate, enable rapid intervention, have a broad antimicrobial menu and be easy to use and affordable. We evaluated the Specific Reveal (Specific Diagnostics, San Jose, CA) rapid AST system on positive blood cultures with Gram-negative organisms in a relatively resistant population in a large urban hospital to assess its potential for routine clinical use. One hundred four randomly selected positive blood cultures (Virtuo; bioMérieux) were Gram stained, diluted 1:1,000 in Pluronic water, inoculated into 96-well antibiotic plates, sealed with the Reveal sensor panel, and placed in the Reveal instrument for incubation and reading. The MIC and susceptible/intermediate/resistant category was determined and compared to results from Vitek 2 (bioMérieux) for the 17 antimicrobials available and to Sensititre (Thermo Fisher) for 24 antimicrobials. Performance was also assessed with contrived blood cultures with 33 highly resistant strains. Reveal was in 98.0% essential agreement (EA) and 96.3% categorical agreement (CA) with Sensititre, with just 1.3% very major error (VME) and 97.0%/96.2%/1.3% EA/CA/VME versus Vitek 2. Reveal results for contrived highly resistant strains were equivalent, with EA/CA/VME of 97.7%/95.2%/1.0% with CDC/FDA Antibiotic Resistance Isolate Bank references. Average time to result (TTR) for Reveal was 4.6 h. Sample preparation was relatively low skill and averaged 3 min. We conclude that the Reveal system enables accurate and rapid susceptibility testing of Gram-negative blood cultures.
及时有效的抗生素治疗对脓毒症至关重要,抗菌药物耐药菌血症的发病率不断上升,促使人们对快速表型药敏试验产生兴趣。为了广泛采用这种方法产生影响,抗生素药敏试验(AST)系统需要准确、能够快速干预、具有广泛的抗菌谱,并且易于使用和负担得起。我们评估了 Specific Reveal(Specific Diagnostics,加利福尼亚州圣何塞)快速 AST 系统在大型城市医院中具有相对耐药性的人群中革兰氏阴性菌阳性血培养中的应用,以评估其在常规临床应用中的潜力。从 Virtuo 中随机选择了 104 份革兰氏阳性血培养物(bioMérieux);将其稀释 1:1000 倍,加入 Pluronic 水中,接种到 96 孔抗生素板中,用 Reveal 传感器面板密封,然后放入 Reveal 仪器中孵育和读取。将 MIC 和敏感/中介/耐药类别确定,并与 17 种抗菌药物的 Vitek 2(bioMérieux)结果和 24 种抗菌药物的 Sensititre(Thermo Fisher)结果进行比较。还使用 33 株高度耐药菌株的人工血培养物评估了性能。Reveal 与 Sensititre 的一致性为 98.0%(基本一致)和 96.3%(分类一致),仅有 1.3%的非常大错误(VME)和 97.0%/96.2%/1.3%的基本一致/分类一致/VME 与 Vitek 2 相比。与 CDC/FDA 抗生素耐药分离株库参考物相比, Reveal 对人工高耐药菌株的结果等效,其基本一致/分类一致/VME 为 97.7%/95.2%/1.0%。Reveal 的平均结果时间(TTR)为 4.6 小时。样本制备相对技能要求较低,平均用时 3 分钟。我们得出结论,Reveal 系统能够对革兰氏阴性血培养物进行准确、快速的药敏试验。