Jones Sara L, Madhusudhan Kunapuli T, Agans Krystle, Dearen Karen, Knight Jennifer, Brasel Trevor, Karamchi Mehdi, Sherwood Robert L
Lovelace Respiratory Research Institute, 2425 Ridgecrest Drive SE, Albuquerque, NM 87108, USA.
559 Stafford Estates Drive, Salisbury, NC 28146, USA.
J Med Microbiol. 2015 Apr;64(Pt 4):382-389. doi: 10.1099/jmm.0.000044. Epub 2015 Feb 24.
The ability of a non-propagating transport device (test device) to maintain the viability of clinically relevant bacteria was compared with a similar commercial device (predicate device) to establish performance equivalence. Test bacteria, namely Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma hominis, Mycoplasma pneumoniae and Ureaplasma urealyticum, were inoculated into the test [Puritan Medical Products Universal Transport System (UniTranz-RT(TM))] and predicate (BD Universal Viral Transport System) devices, and incubated at 4 °C and room temperature for up to 72 h. Bacterial viability was assessed at selected time points post-incubation using shell vial assays followed by immunofluorescence staining (for Chlamydia) or by standard culture techniques (for Mycoplasma and Ureaplasma). Results indicated that the Chlamydia strains were equally stable in both test and predicate devices through 72 h storage, at both test temperatures. Quantifiable levels of Mycoplasma and Ureaplasma were recovered from the test and predicate devices throughout the storage period. Low-temperature storage improved bacterial viability when compared with room temperature storage. In addition, the predicate device demonstrated slightly improved performance versus the test device in the context of Mycoplasma and Ureaplasma following 72 h storage. The overall results of the study confirmed the full performance of UniTranz-RT(TM) as a microbial transport medium and established equal performance with the predicate device.
将一种非传播性运输装置（测试装置）维持临床相关细菌生存能力的能力与一种类似的商用装置（对照装置）进行比较，以确定性能等效性。将测试细菌，即沙眼衣原体、肺炎衣原体、人型支原体、肺炎支原体和解脲脲原体接种到测试装置[Puritan Medical Products通用运输系统（UniTranz-RT(TM)）]和对照装置（BD通用病毒运输系统）中，并在4℃和室温下孵育长达72小时。孵育后在选定的时间点使用空斑试验，随后进行免疫荧光染色（用于衣原体）或通过标准培养技术（用于支原体和脲原体）评估细菌生存能力。结果表明，在两种测试温度下，衣原体菌株在测试装置和对照装置中储存72小时内均同样稳定。在整个储存期间，从测试装置和对照装置中均回收了可量化水平的支原体和脲原体。与室温储存相比，低温储存提高了细菌生存能力。此外，在储存72小时后，对照装置在支原体和脲原体方面的性能相对于测试装置略有改善。该研究的总体结果证实了UniTranz-RT(TM)作为微生物运输培养基的全面性能，并确定其与对照装置性能相当。
