多重免疫层析法在临床微生物实验室快速鉴定碳青霉烯酶的应用：NG-test Carba 5 的性能和周转时间评估。
Application of a multiplex immunochromatographic assay for rapid identification of carbapenemases in a clinical microbiology laboratory: performance and turn-around-time evaluation of NG-test Carba 5.
机构信息
Department of Laboratory Medicine, Korea University College of Medicine, 126-1, Anam-dong 5-ga, Seongbuk-gu, Seoul, 02841, Republic of Korea.
Department of Laboratory Medicine, Korea University Medical Center (KUMC), Guro Hospital, Seoul, South Korea.
出版信息
BMC Microbiol. 2021 Sep 29;21(1):260. doi: 10.1186/s12866-021-02309-9.
BACKGROUND
Prompt and accurate identification of carbapenemase production is essential for appropriate treatment and infection control. NG-Test Carba 5 (termed herein "Carba 5"; NG Biotech, Guipry, France) is a multiplex immunochromatographic assay for the rapid phenotypic identification of five major carbapenemases (KPC, NDM, VIM, IMP, and OXA-48-like) from bacterial isolates. This study aimed to evaluate the diagnostic performance of Carba 5 and its impact on the turn-around-time in a clinical microbiology laboratory.
RESULTS
Carba 5 was retrospectively evaluated using 78 carbapenemase producers and 23 non-carbapenemase producers confirmed by PCR and sequencing. The performance and time required for carbapenemase identification were prospectively evaluated using 47 carbapenem resistant Enterobacteriaceae isolates, and the results were compared to those obtained using Xpert Carba-R (Cepheid, Sunnyvale, CA, USA). For the bacterial isolates included in retrospective and prospective evaluation, the Carba 5 assay correctly identified 147 isolates except one isolate with a sensitivity of 99.13% (95% CI 95.25-99.98%) and specificity of 100% (95% CI 89.42-100%). The Carba 5 assay missed one VIM-1 among 13 VIM producers. The assay showed a sensitivity of 92.31% (95% CI 63.97-99.81%) for detecting VIM and 100% for detecting KPC, NDM, OXA-48-like, and IMP. Compared to the Xpert Carba-R assay, Carba 5 exhibited 100% agreement and was more time-efficient (median time 24 min vs. 1 h 11 min).
CONCLUSIONS
The Carba 5 assay has potential as an alternative to molecular methods for detecting major carbapenemases from bacterial isolates in a clinical microbiology laboratory. Compared to the Xpert Carba-R, Carba 5 turns out to be more affordable and time-efficient while showing a comparable performance, and may accelerate therapeutic and infection control decisions.
背景
快速准确地识别碳青霉烯酶的产生对于适当的治疗和感染控制至关重要。NG-Test Carba 5（在此称为“Carba 5”；NG Biotech，Guipry，法国）是一种用于快速鉴定来自细菌分离物的五种主要碳青霉烯酶（KPC、NDM、VIM、IMP 和 OXA-48 样）的多重免疫层析检测法。本研究旨在评估 Carba 5 的诊断性能及其对临床微生物学实验室周转时间的影响。
结果
使用聚合酶链反应（PCR）和测序确认的 78 株碳青霉烯酶产生菌和 23 株非碳青霉烯酶产生菌对 Carba 5 进行了回顾性评估。使用 47 株耐碳青霉烯类肠杆菌科分离株前瞻性评估了碳青霉烯酶鉴定所需的时间和性能，并将结果与使用 Xpert Carba-R（Cepheid，Sunnyvale，CA，美国）获得的结果进行了比较。对于包括在回顾性和前瞻性评估中的细菌分离株，Carba 5 检测法正确鉴定了除一株灵敏度为 99.13%（95%置信区间 95.25-99.98%）和特异性为 100%（95%置信区间 89.42-100%）的分离株外的 147 株分离株。该检测法漏检了 13 株 VIM 产酶株中的一株 VIM-1。该检测法对检测 VIM 的灵敏度为 92.31%（95%置信区间 63.97-99.81%），对检测 KPC、NDM、OXA-48 样和 IMP 的灵敏度为 100%。与 Xpert Carba-R 检测法相比，Carba 5 表现出 100%的一致性，且用时更短（中位数时间 24 分钟 vs. 1 小时 11 分钟）。
结论
Carba 5 检测法有望替代分子方法，用于临床微生物学实验室中从细菌分离物中检测主要碳青霉烯酶。与 Xpert Carba-R 相比，Carba 5 不仅具有成本效益和时间效益，而且性能相当，可能会加速治疗和感染控制决策。
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