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<sup>TM</sup>)] and predicate (BD Universal Viral Transport System) devices, and incubated at 4 6C and room temperature for up to 72 h. Bacterial viability was assessed at selected time points postincubation 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<sup>TM</sup> as a microbial transport medium and established equal performance with the predicate device.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 382-389 |
| Number of pages | 8 |
| Journal | Journal of Medical Microbiology |
| Volume | 64 |
| Issue number | 4 |
| DOIs | |
| State | Published - 2015 |
| Externally published | Yes |
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ASJC Scopus subject areas
- Microbiology (medical)
- Microbiology
Cite this
Performance evaluation of two microbial transport media designed for preservation and transport of Chlamydiae, Mycoplasma and Ureaplasma. / Jones, Sara L.; Madhusudhan, Kunapuli T.; Agans, Krystle; Dearen, Karen; Knight, Jennifer; Brasel, Trevor; Karamchi, Mehdi; Sherwood, Robert L.
In: Journal of Medical Microbiology, Vol. 64, No. 4, 2015, p. 382-389.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Performance evaluation of two microbial transport media designed for preservation and transport of Chlamydiae, Mycoplasma and Ureaplasma
AU - Jones, Sara L.
AU - Madhusudhan, Kunapuli T.
AU - Agans, Krystle
AU - Dearen, Karen
AU - Knight, Jennifer
AU - Brasel, Trevor
AU - Karamchi, Mehdi
AU - Sherwood, Robert L.
PY - 2015
Y1 - 2015
N2 - 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-RTTM)] and predicate (BD Universal Viral Transport System) devices, and incubated at 4 6C and room temperature for up to 72 h. Bacterial viability was assessed at selected time points postincubation 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-RTTM as a microbial transport medium and established equal performance with the predicate device.
AB - 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-RTTM)] and predicate (BD Universal Viral Transport System) devices, and incubated at 4 6C and room temperature for up to 72 h. Bacterial viability was assessed at selected time points postincubation 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-RTTM as a microbial transport medium and established equal performance with the predicate device.
UR - http://www.scopus.com/inward/record.url?scp=84927732718&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84927732718&partnerID=8YFLogxK
U2 - 10.1099/jmm.0.000044
DO - 10.1099/jmm.0.000044
M3 - Article
C2 - 25713205
AN - SCOPUS:84927732718
VL - 64
SP - 382
EP - 389
JO - Journal of Medical Microbiology
JF - Journal of Medical Microbiology
SN - 0022-2615
IS - 4
ER -