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新型超长效糖肽类药物达巴万星药敏试验中商业干型肉汤微量稀释板的验证及试验可重复性

Validation of commercial dry-form broth microdilution panels and test reproducibility for susceptibility testing of dalbavancin, a new very long-acting glycopeptide.

作者信息

Jones Ronald N, Streit Jennifer M, Fritsche Thomas R

机构信息

The JONES Group/JMI Laboratories, 345 Beaver Kreek Centre, Suite A, North Liberty, IA 52317, USA.

出版信息

Int J Antimicrob Agents. 2004 Feb;23(2):197-9. doi: 10.1016/j.ijantimicag.2003.07.008.

Abstract

Results from dalbavancin dry-form commercial broth microdilution MIC panels (Sensititre, TREK Diagnostics) were compared with reference frozen-form MIC values to assure the validity and reproducibility of the extended shelf-life product. A collection of 402 organisms from four major organism groups were used in the validation trial and 10 strains for reproducibility replicate tests. A total of 98.6% commercial dalbavancin MIC results were within +/-1 log(2) dilution of reference values (76.2% were identical) and reproducibility trials produced identical MIC results in 88.9-92.2% of dalbavancin MIC comparisons. These dalbavancin MIC results demonstrated the acceptable accuracy of commercially-prepared broth microdilution products for use in subsequent clinical trials.

摘要

将达巴万星干剂型商业肉汤微量稀释MIC板(Sensititre,TREK诊断公司)的结果与参考冷冻剂型MIC值进行比较,以确保延长保质期产品的有效性和可重复性。在验证试验中使用了来自四个主要生物体组的402种生物体的集合,并使用10个菌株进行可重复性重复测试。达巴万星商业MIC结果中,共有98.6%在参考值的+/-1 log(2)稀释范围内(76.2%相同),并且在88.9 - 92.2%的达巴万星MIC比较中,可重复性试验产生了相同的MIC结果。这些达巴万星MIC结果证明了商业制备的肉汤微量稀释产品在后续临床试验中使用时具有可接受的准确性。

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