1887

Abstract

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 , , , and , were inoculated into the test [Puritan Medical Products Universal Transport System (UniTranz-RT)] 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 ) or by standard culture techniques (for and ). Results indicated that the strains were equally stable in both test and predicate devices through 72 h storage, at both test temperatures. Quantifiable levels of and 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 and following 72 h storage. The overall results of the study confirmed the full performance of UniTranz-RT as a microbial transport medium and established equal performance with the predicate device.

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2015-04-01
2019-10-18
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