Selux Diagnostics, Charlestown, Massachusetts, USA.
Pathology and Laboratory Medicine, Loyola University Medical Center, Maywood, Illinois, USA.
J Clin Microbiol. 2024 Jan 17;62(1):e0054623. doi: 10.1128/jcm.00546-23. Epub 2023 Dec 5.
The Selux Next-Generation Phenotyping (NGP) system (Charlestown, MA) is a new antimicrobial susceptibility testing system that utilizes two sequential assays performed on all wells of doubling dilution series to determine MICs. A multicenter evaluation of the performance of the Selux NGP system compared with reference broth microdilution was conducted following FDA recommendations and using FDA-defined breakpoints. A total of 2,488 clinical and challenge isolates were included; gram-negative isolates were tested against 24 antimicrobials, and gram-positive isolates were tested against 15 antimicrobials. Data is provided for all organism-antimicrobial combinations evaluated, including those that did and did not meet FDA performance requirements. Overall very major error and major error rates were less than 1% (31/3,805 and 107/15,606, respectively), essential agreement and categorical agreement were >95%, reproducibility was ≥95%, and the average time-to-result (from time of assay start to time of MIC result) was 5.65 hours.
Selux 下一代表型检测(NGP)系统(马萨诸塞州查尔斯顿)是一种新的抗菌药物敏感性测试系统,它利用在所有倍比稀释系列孔中进行的两个连续检测来确定 MIC 值。根据 FDA 的建议并使用 FDA 定义的折点,对 Selux NGP 系统与参考肉汤微量稀释法的性能进行了多中心评估。共纳入了 2488 例临床和挑战性分离株;革兰氏阴性分离株检测了 24 种抗菌药物,革兰氏阳性分离株检测了 15 种抗菌药物。提供了所有评估的生物体-抗菌药物组合的数据,包括符合和不符合 FDA 性能要求的组合。总体上,非常大错误和主要错误率低于 1%(分别为 31/3805 和 107/15606),基本一致性和分类一致性>95%,重现性≥95%,平均结果时间(从检测开始到 MIC 结果时间)为 5.65 小时。