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A Quarterly Publication by Cepheid
Volume 4, Issue 1
COVER STORY 3
The Need for
Better Diagnostic
Tests for Pediatric
Tuberculosis
Lead Author
Ellen Jo Baron, Ph.D.
Contributing Author
Fred Tenover, Ph.D.
INSIDE 8
Clostridium difficile
Ribotype 027:
Why Should We Care?
INSIDE 10
Wake-Up Call:
Proficiency
Testing for Todays
Technology
editor@cepheidondemand.com
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David Persing
M.D., Ph.D.
I am privileged at Cepheid to work with the some of the best minds in the diagnostics
business. In this month's issue of the On-Demand newsletter, Dr. Ellen Jo Baron
highlights the role of decentralized molecular testing in TB diagnostics, with a special
focus on the nearly impossible challenge of diagnosing pediatric TB. This is a truly
moving story which begs the question: Is there not a better solution? Cepheid is
committed to developing less invasive diagnostic tools for TB in kids and in all patients
with HIV where current diagnostic options are, simply put, woefully suboptimal. I am
optimistic that Ellen Jo and her colleagues inside and outside the company will come
up with a better way.
Also highlighted in this issue is 1) the need for suitable external controls for molecular
diagnostic assays, and 2) the impact of the emergence of the 027 strain of C. difficile.
We hope you enjoy reading this information as we much as we have in preparing it.
Ellen Jo Baron
Ph.D., D(ABMM)
Prof. Emerita, Stanford University
Director of Medical Affairs,Cepheid
1
3
2
6
4
7
Clostridium difficile
Ribotype 027:
The first hint that something
new was happening with
regard to Clostridum
difficile infections (CDI)
was a study presented at
the 2004 annual meeting
of the Infectious Diseases
Society of America by
epidemiologists from the
Centers for Disease Control
and Prevention (CDC)
and other investigators
describing an emerging
epidemic strain that was
typically resistant to
fluoroquinolones.1
Wake-Up Call:
10
11
REFERENCES
The Need for Better Diagnostic Tests for Pediatric Tuberculosis
1. McDonald, L. C., et al. 2004. Emergence of an epidemic strain of Clostridium difficile in the
United States 20014: potential role for virulence factors and antimicrobial resistance traits Abstract LB-2. Presented at 42nd Annual Meeting of the Infectious Diseases Society of America,
Boston, MA, 2004.
2. Warny, M., et al. 2005. Toxin production by an emerging strain of Clostridium difficile associated
with outbreaks of severe disease in North America and Europe. Lancet. 366: 1079-1084.
3. Kuijper, E. J., et al. 2006. Emergence of Clostridium difficile-associated disease in North America
and Europe. Clin Microbiol Infect. 12 Suppl 6: 2-18.
4. O'Connor, J. R., et al. 2009. Clostridium difficile infection caused by the epidemic BI/NAP1/027
strain. Gastroenterology. 136: 1913-1924.
5. Lyras, D., et al. 2009. Toxin B is essential for virulence of Clostridium difficile. Nature. 458: 11761179.
6. Kuehne, S. A., et al. The role of toxin A and toxin B in Clostridium difficile infection. Nature. 467:
711-713.
7. Merrigan, M., et al. Human hypervirulent Clostridium difficile strains exhibit increased sporulation
as well as robust toxin production. J Bacteriol. 192: 4904-4911.
8. Vohra, P. & I. Poxton. Comparison of toxin and spore production in clinically relevant strains of
Clostridium difficile. Microbiology.
9. Carter, G. P., et al. 2007. Binary toxin production in Clostridium difficile is regulated by CdtR, a
LytTR family response regulator. J Bacteriol. 189: 7290-7301.
10. Boyce, J. M., et al. 2008. Impact of hydrogen peroxide vapor room decontamination on
Clostridium difficile environmental contamination and transmission in a healthcare setting. Infect
Control Hosp Epidemiol. 29: 723-729.
11. Voelker, R. Increased Clostridium difficile virulence demands new treatment approach. JAMA.
303: 2017-2019.
12. Muto, C. A., et al. 2007. Control of an outbreak of infection with the hypervirulent Clostridium
difficile BI strain in a university hospital using a comprehensive "bundle" approach. Clin Infect Dis.
45: 1266-1273.
13. Owens, R. C., Jr., et al. 2008. Antimicrobial-associated risk factors for Clostridium difficile
infection. Clin Infect Dis. 46 Suppl 1: S19-31.
14. Louie, T. J., et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med.
364: 422-431.
15. Cohen, S. H., et al. Clinical Practice Guidelines for Clostridium difficile Infection in Adults: 2010
Update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious
Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 31: 431-455.
A better way.
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