1887

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Volume 64, Issue 4

Performance evaluation of two microbial transport media designed for preservation and transport of , and Free

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.

  • Received:
  • Accepted:
  • Published Online:
Funding
This study was supported by the:
  • Puritan Medical Products LLC
© 2015 The Authors
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/content/journal/jmm/10.1099/jmm.0.000044
2015-04-01
2024-04-19
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References

  1. Azenabor A. A., Kennedy P., Balistreri S. 2007; Chlamydia trachomatis infection of human trophoblast alters estrogen and progesterone biosynthesis: an insight into role of infection in pregnancy sequelae. Int J Med Sci 4:223–231 [View Article][PubMed]
     [Google Scholar]
  2. Barger, M., Vestal, D., Engler, H. D. & Body, B. A. (2005). Evaluation of Copan Universal Transport Media UTM compared to Remel M4 and M4 RT transport media for the recovery of viruses chlamydia ureaplasma and mycoplasma Presented at the 21st Annual Clinical Virology Symposium Clearwater Beach FL
  3. Baron E. J., Miller J. M., Weinstein M. P., Richter S. S., Gilligan P. H., Thomson R. B. Jr, Bourbeau P., Carroll K. C., Kehl S. C. et al. 2013; Executive summary: a guide to utilization of the microbiology laboratory for diagnosis of infectious diseases: 2013 recommendations by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM). Clin Infect Dis 57:485–488 [View Article][PubMed]
     [Google Scholar]
  4. Broitman N. L., Floyd C. M., Johnson C. A., de la Maza L. M., Peterson E. M. 1992; Comparison of commercially available media for detection and isolation of Ureaplasma urealyticum and Mycoplasma hominis . J Clin Microbiol 30:1335–1337[PubMed]
     [Google Scholar]
  5. Chernesky M., Castriciano S., Jang D., Smieja M. 2006; Use of flocked swabs and a universal transport medium to enhance molecular detection of Chlamydia trachomatis and Neisseria gonorrhoeae . J Clin Microbiol 44:1084–1086 [View Article][PubMed]
     [Google Scholar]
  6. Clark, G. S. (1991). Shelf life of medical devices Washington DC US Food and Drug Administration http://www.fda.gov/downloads/MedicalDevices/.../UCM081366.pdf
  7. European Collection of Cell Cultures 2010 Fundamental Techniques in Cell Culture Laboratory Handbook, 2nd edn. St Louis, MO: Sigma-Aldrich;
     [Google Scholar]
  8. FDA (2004). Summary for Copan Universal Transport Medium UTM-RT System http://www.accessdata.fda.gov/cdrh_docs/pdf4/k042970.pdf
  9. FDA (2012). Substantial equivalence determination decision summary assay only template http://www.accessdata.fda.gov/cdrh_docs/reviews/k042790.pdf
  10. Gamova N. A., Ivanova T. A. 2013; [Dynamics of change of ureaplasma laboratory strain titers and quantity of their DNA in transport medium at varying temperature]. Zh Mikrobiol Epidemiol Immunobiol 2:21–27 in Russian [PubMed]
     [Google Scholar]
  11. Garcia L. S., Procop G. W., Roberts G. D. 1998; General issues in clinical microbiology. In Diagnostic Microbiology pp 2–84Edited by Forbes B. A., Sahm D. F., Weissfeld A. S. St Louis, MO: Mosby;
     [Google Scholar]
  12. Granato P. A., Poe L., Weiner L. B. 1983; New York City medium for enhanced recovery of Mycoplasma pneumoniae from clinical specimens. J Clin Microbiol 17:1077–1080[PubMed]
     [Google Scholar]
  13. Harry K. H., Madhusudhan K. T. 2014; Effect of protein coating of flocked swabs on the collection and release of clinically important bacteria. Indian J Med Microbiol 32:301–303 [View Article][PubMed]
     [Google Scholar]
  14. Harry K. H., Turner J. C., Madhusudhan K. T. 2013; Comparison of physical characteristics and collection and elution performance of clinical swabs. African J Microbiol Res 7:4039–4048
     [Google Scholar]
  15. Johnson F. B. 1990; Transport of viral specimens. Clin Microbiol Rev 3:120–131[PubMed]
     [Google Scholar]
  16. Johnson R. E., Newhall W. J., Papp J. R., Knapp J. S., Black C. M., Gift T. L., Steece R., Markowitz L. E., Devine O. J. et al. 2002; Screening tests to detect Chlamydia trachomatis and Neisseria gonorrhoeae infections – 2002. MMWR Recomm Rep 51:RR-151–38[PubMed]
     [Google Scholar]
  17. Kuo C. C., Grayston J. T. 1988; Factors affecting viability and growth in HeLa 229 cells of Chlamydia sp. strain TWAR. J Clin Microbiol 26:812–815[PubMed]
     [Google Scholar]
  18. Rakovskaia I. V., Barkhatova O. I., Balabanov D. N., Gorina L. G., Goncharova S. A., Gamova N. A. 2008; [Duration of preservation of viable cells, DNA, and antigens of Mycoplasma hominis and ureaplasmas in human serum at 37 degrees C]. Klin Lab Diagn 11:40–42 in Russian [PubMed]
     [Google Scholar]
  19. Reed L. J., Muench H. 1938; A simple method of estimating fifty percent endpoints. Am J Hyg 27:493–497
     [Google Scholar]
  20. Sall J., Creighton L., Lehman A. 2007 JMP Start Statistics: A Guide to Statistics and Data Analysis Using JMP, 4th edn. pp 95–231 Cary, NC: SAS Publishing;
     [Google Scholar]
  21. Schachter J. 2000; Chlamydiae. In Clinical Virology Manual pp 561–567Edited by Specter S., Hodinka R. L., Young S. A. Washington, DC: American Society for Microbiology;
     [Google Scholar]
  22. Stoner K. A., Rabe L. K., Austin M. N., Meyn L. A., Hillier S. L. 2008; Quantitative survival of aerobic and anaerobic microorganisms in Port-A-Cul and Copan transport systems. J Clin Microbiol 46:2739–2744 [View Article][PubMed]
     [Google Scholar]
  23. Theunissen J. J., van Heijst B. Y., Wagenvoort J. H., Stolz E., Michel M. F. 1992; Factors influencing the infectivity of Chlamydia pneumoniae elementary bodies on HL cells. J Clin Microbiol 30:1388–1391[PubMed]
     [Google Scholar]
  24. Tjiam K. H., van Heijst B. Y., de Roo J. C., de Beer A., van Joost T., Michel M. F., Stolz E. 1984; Survival of Chlamydia trachomatis in different transport media and at different temperatures: diagnostic implications. Br J Vener Dis 60:92–94[PubMed]
     [Google Scholar]
  25. Tully J. G., Taylor-Robinson D., Rose D. L., Furr P. M., Hawkins D. A. 1983; Evaluation of culture media for the recovery of Mycoplasma hominis from the human urogenital tract. Sex Transm Dis 10:Suppl256–260[PubMed]
     [Google Scholar]
  26. Waites K. B. 2006; Mycoplasma and Ureaplasma . In Congenital and Perinatal Infections pp 271–288Edited by Hutto C. Totowa, NJ: Humana Press; [View Article]
     [Google Scholar]
  27. Wilson M. L. 1996; General principles of specimen collection and transport. Clin Infect Dis 22:766–777 [View Article][PubMed]
     [Google Scholar]
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Performance evaluation of two microbial transport media designed for preservation and transport of Chlamydiae, Mycoplasma and Ureaplasma
J. Med. Microbiol. 64, 382 (2015); https://doi.org/10.1099/jmm.0.000044
/content/journal/jmm/10.1099/jmm.0.000044
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