在尿路感染病原体中使用CLSI方法和性能标准进行聚合抗生素敏感性测试的全面验证.
Richard A Festa1, Frank R Cockerill2, Rick L Pesano2
1Department of Research and Development, Pathnostics, Irvine, CA 92618, USA.
Antibiotics (Basel, Switzerland)
|November 27, 2025
概括
聚合抗生素敏感性测试 (P-AST) 是对复杂的尿路感染 (UTI) 进行验证的快速测试. 它符合临床和实验室标准研究所 (CLSI) 的性能标准,用于准确和精确地确定细菌对抗生素的耐药性.
科学领域:
- 临床微生物学 临床微生物学
- 抗微生物耐药性 抗微生物耐药性
- 诊断试验验证的验证方法
背景情况:
- 复杂,持久和复发的尿路感染 (UTI) 需要准确和快速的抗菌感应性测试.
- 对于复杂的尿路感染病例,现有的方法可能不够快速或全面.
- 聚合抗生素敏感性测试 (P-AST) 是一项旨在应对这些挑战的新型测试.
研究的目的:
- 为了验证P-AST测定用于识别泌尿病原菌的性能.
- 根据已建立的临床和实验室标准研究所 (CLSI) 协议和性能指标来评估P-AST.
- 评估P-AST对于单微生物和多微生物尿样.
主要方法:
- 与标准磁盘扩散和微稀释参考方法相比,P-AST得到了验证.
- 在五组尿病原体生物体 (Enterobacterales,Enterococci,Staphylococci,Pseudomonas aeruginosa,Acinetobacter物种) 的表现进行了评估.
- 测试包括新鲜和冷的临床尿样以及人工样本,对20种相关抗生素进行测试.
主要成果:
- P-AST满足了CLSI的绩效标准,包括≥90.0%的分类一致性和低错误率 (<3.0%非常重大和重大错误).
- 在所有分析组中,精度超过95.0%.
- 在单微生物和多微生物分析中观察到最小的错误,每种生物-抗生素对不超过一个非常重大或重大错误.
结论:
- 作为Guidance®尿道感染检测的组成部分,P-AST检测证明了抗生素敏感性测试的可接受性能.
- 与标准和参考方法相比,P-AST符合CLSI值.
- 该试验适用于单微生物和多微生物标本,支持其在复杂的尿路感染病例中使用.
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