title: Performance evaluation of two microbial transport media designed for preservation and transport of Chlamydiae, Mycoplasma and Ureaplasma.
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 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.
authors.affiliation: Lovelace Respiratory Research Institute, 2425 Ridgecrest Drive SE, Albuquerque, NM 87108, USA.
authors.forename: Sara L
authors.initials: SL
authors.lastname: Jones
authors.affiliation: 559 Stafford Estates Drive, Salisbury, NC 28146, USA.
authors.forename: Kunapuli T
authors.initials: KT
authors.lastname: Madhusudhan
authors.affiliation: Lovelace Respiratory Research Institute, 2425 Ridgecrest Drive SE, Albuquerque, NM 87108, USA.
authors.forename: Krystle
authors.initials: K
authors.lastname: Agans
authors.affiliation: Lovelace Respiratory Research Institute, 2425 Ridgecrest Drive SE, Albuquerque, NM 87108, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Dearen
authors.affiliation: Lovelace Respiratory Research Institute, 2425 Ridgecrest Drive SE, Albuquerque, NM 87108, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Knight
authors.affiliation: Lovelace Respiratory Research Institute, 2425 Ridgecrest Drive SE, Albuquerque, NM 87108, USA.
authors.forename: Trevor
authors.initials: T
authors.lastname: Brasel
authors.affiliation: 31 School Street, PO Box 149, Guilford, ME 04443, USA.
authors.forename: Mehdi
authors.initials: M
authors.lastname: Karamchi
authors.affiliation: Lovelace Respiratory Research Institute, 2425 Ridgecrest Drive SE, Albuquerque, NM 87108, USA.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Sherwood
mesh_terms: D001431:Bacteriological Techniques / Q000379:methods*; D002689:Chlamydia / Q000302:isolation & purification*; D002690:Chlamydia Infections / Q000175:diagnosis / Q000382:microbiology; D006801:Humans; D050296:Microbial Viability; D009174:Mycoplasma / Q000302:isolation & purification*; D009175:Mycoplasma Infections / Q000175:diagnosis / Q000382:microbiology; D010865:Pilot Projects; D013048:Specimen Handling / Q000379:methods*; D013696:Temperature; D013997:Time Factors; D016869:Ureaplasma Infections / Q000175:diagnosis / Q000382:microbiology; D016990:Ureaplasma urealyticum / Q000302:isolation & purification*