Monday, 23 January 2017 09:30

Clinical Microbiology Issues Update - January 2017

PSAB ACTIVITIES

ASM Writes Letter to Incoming Administration on Vaccine Science
The American Society for Microbiology staunchly supports the universal use of licensed and approved vaccines to prevent illness and death linked to numerous infectious diseases. ASM also publishes the journal Clinical and Vaccine Immunology which enhances understanding of the immune response in health and disease and after vaccination by showcasing discoveries in clinical, laboratory, and vaccine immunology. 

ASM Public Affairs Staff Participate in FDA Listening Session
Public Affairs Director Janet Shoemaker participated in a listening session on rare diseases, rheumatology, infectious disease and cystic fibrosis with FDA Commissioner Califf and several FDA center directors.

ASM Staff Attend CDC AMD Program External Peer Review
ASM staff attended the December external peer review of the Centers for Disease Control and Prevention’s Advance Molecular Detection (AMD) program.  This meeting consisted of a review of AMD progress and challenges and included reports on PulseNet, metagenomics for identification of pathogens from clinical samples, influenza virus surveillance, and the introduction of MicrobeNet, an online virtual reference laboratory.

ASM Staff Attend FDA Microbiology Devices Panel Meeting
ASM staff attended the November 9 FDA Microbiology Medical Devices Panel of the Medical Devices Advisory Committee; the topic of the meeting was reclassification of CMV, EBV, and BK viral load tests from Class III to Class II devices.  As this reclassification has the potential to affect laboratory practice, ASM and the Pan American Society for Clinical Virology (PASCV) made joint comments on the transplant virus testing, indicating support for the proposal.  

ASM, AMP and PASCV Express Concerns over Newest Molecular Test for Zika
In light of recent concerns regarding test performance characteristics of the Trioplex rRT-PCR assay for identification of Zika, dengue and chikungunya viruses, ASM, the Association for Molecular Pathology (AMP), and PASCV authored a joint letter to the Centers for Disease Control and Prevention (CDC) requesting additional data on this test.

ASM Joins PEW, IDSA and BD in Senate HELP Committee Letter on Breakpoints
The ASM, Pew Charitable Trusts, Infectious Diseases Society of America, and Becton, Dickinson and Company (BD), jointly authored a letter to the Senate Health, Education, Labor and Pensions (HELP) committee requesting support of Section 2121 of H.R. 6, “The 21st Century Cures Act”, which would streamline the process of updating antibiotic breakpoints.

ASM Joins November CCCLW Meeting
The Coordinating Council on the Clinical Laboratory Workforce (CCCLW) is a coalition of laboratory organizations working together to ensure a high quality workforce.  The November 14 meeting, which ASM staff attended with other members of the coalition, included the roll-out of the newly updated website, found here http://www.ccclw.org/, and discussion of upcoming projects.  The official ASM representative to CCCLW is Professional Affairs Committee member Janice Matthews-Greer.

ASM Publishes January Issue of the Minority Microbiology Mentor
The January issue of the Minority Microbiology Mentor has been published by the Committee on Microbiological Issues Impacting Minorities (CMIIM).

ASM NEWS, JOURNAL ARTICLES AND UPDATES

Evidence Based Guideline on C. difficile Laboratory Diagnosis
ASM’s Evidence-based Laboratory Medicine Practice Guideline Committee is currently developing an evidence-based guideline for the laboratory diagnosis of Clostridium difficile.  In addition to having performed a systematic literature review which resulted in the discovery of over 8,000 papers, the committee is in need of “grey” data to ensure compliance with the evidence-based medicine guidelines process.  “Grey” data includes nonpublished data including Posters and Abstracts.  The importance of obtaining “grey” data is to avoid publication bias which is the tendency for journals to publish data having on only a positive effect or outcome rather than data showing no effect.  This could potentially lead to the publishing of incorrect recommendations.  The committee would appreciate your sharing any data that has been generated regarding the laboratory detection of C. difficile including studies of PCR based diagnostic methods, 2 and 3 step algorithms used for diagnosis, the value or lack thereof of repeat testing, and the association of these diagnostic strategies with patient outcomes such as length of stay, costs to the institution, use of antibiotics and readmission rates (quality of life factors) and/or economic factors such as cost. Please forward information to Jim Snyder jwsnyd01@louisville.edu; Colleen Kraft colleen.kraft@emory.edu; or Peggy McNult pmcnult@asmusa.org

ASM Conferences

ASM Conference on Mechanisms of Interbacterial Cooperation and Competition
March 1-4, 2017
Washington, DC

ASM Conference on Innovative Microbial Ecology for Mitigation of Antibiotic Resistance and Bacterial Diseases
March 22-25, 2017
Crystal City, VA

ASM Conference on Tuberculosis: Past, Present and Future
April 1-4, 2017
New York, NY

ASM/ASV Conference on Interplay of Viral and Bacterial Pathogens
May 1-4, 2017
Bethesda, MD

For a complete list of upcoming ASM conferences, please see http://conferences.asm.org/.

ASM Journal Articles of Interest

Flavivirus Infection Uncouples Translation Suppression from Cellular Stress Responses
Researchers in Germany have discovered that flaviviruses use an unexpected mechanism to subvert the cellular machinery to replicate themselves.  Dengue and Zika uncouple translation suppression from the host cell stress responses to ensure efficient replication in human cells.  

A Rose by Any Other Name: Practical Updates on Microbial Nomenclature for Clinical Microbiology
The clinical microbiology laboratory stands at the interface between basic science, including the study of phylogeny, and applications of science in the very practical world of medical care. New organisms are discovered and named, and our understanding of the relationships between known organisms improves, resulting in the reclassification and renaming of organisms as they are sorted into the correct groups. 

Clinical Microbiology Laboratories' Adoption of Culture-Independent Diagnostic Tests Is a Threat to Foodborne-Disease Surveillance in the United States
Culture-independent diagnostic tests (CIDTs) are improving diagnostics in ways that benefit patient care. CIDTs can test for an array of clinically important infections more quickly and effectively than other methods can, however, isolates so critical for public health investigation of outbreaks are being lost.  

Evaluation of the Carba NP Test in Oregon, 2013
Carbapenem-resistant Enterobacteriaceae (CRE) are an urgent public health threat. Researchers evaluated the capacity of the Carba NP test to detect carbapenemase production in 206 isolates.  

ASM Press

Urinary Tract Infections, Second Edition
Editors: Matthew A. Mulvey, David Klumpp, Ann Stapleton
Hardcover, 690 pages, full-color illustrations, index.
(ISBN: 9781555817398) 

Clinical Virology, Fourth Edition
Editors: Douglas D. Richman, Richard J. Whitley, Frederick G. Hayden
Hardcover, 1,489 pages, illustrations, index.
(ISBN: 9781555819422) 

Articles of Interest

Efficacy and Effectiveness of an rVSV-vectored Vaccine Expressing Ebola Surface Glycoprotein
A recombinant, replication-competent vesicular stomatitis virus-based vaccine expressing a surface glycoprotein of Zaire Ebolavirus (rVSV-ZEBOV) is a promising Ebola vaccine candidate.  Investigators report the results of an interim analysis of a trial of rVSV-ZEBOV in Guinea.  

FEDERAL AGENCY UPDATES

Final Rule Enhances Protections for Research Participants, Modernizes Oversight
The U.S. Department of Health and Human Services and 15 other federal agencies issued a final rule to update regulations that safeguard individuals who participate in research. The new rule strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to low-risk research. 

OSTP Issues Recommended Policy Guidance for Potential Pandemic Pathogens 
On January 9, the Office of Science and Technology Policy (OSTP) issued the “Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO).”  Adoption of these recommendations will satisfy the requirements for lifting the current moratorium on certain life sciences research that could enhance a pathogen’s virulence and/or transmissibility. 

Teleconference of the Board of Scientific Counselors, Office of Infectious Diseases
On January 23, the Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID) of the Centers for Disease Control and Prevention will host a public teleconference.  Topics to be discussed during the teleconference include (1) discussion and vote on the Food Safety Modernization Act Surveillance Working Group Annual Report to the Secretary of Health and Human Services and (2) a report back from a recent external review of CDC's advanced molecular detection activities. 

The 21st Century Cures Bill Passes
H.R. 31, the 21st Century Cures act, became Public Law No: 114-255 on December 13.  This comprehensive bill has been making its way through Congress since 2015.

NIH Scientists Develop New Mouse Model to Study Salmonella Meningitis
National Institutes of Health (NIH) scientists have established in mice a way to study potentially life-threatening meningitis caused by Salmonella Typhimurium.  Patients who survive bacterial meningitis often have permanent brain damage. 

NIH Launches First Large Trial of a Long-Acting Injectable Drug for HIV Prevention
The first large-scale clinical trial to test efficacy and safety of injectable cabotegravir compared to daily oral PrEP began on December 20.  The study will examine whether a long-acting form of the investigational anti-HIV drug cabotegravir injected once every 8 weeks can safely protect men and transgender women from HIV infection at least as well as the anti-HIV medication Truvada taken daily as a tablet. 

NIAID-Sponsored Study to Assess Shorter-Duration Antibiotics in Children
Physicians at five U.S. medical centers are planning to enroll up to 400 children in a clinical trial to evaluate whether a shorter course of antibiotics, five days instead of 10, is effective at treating community-acquired pneumonia (CAP) in children who show improvement after the first few days of taking antibiotics. 

FDA Research to Help Speed Development of Zika virus Vaccines and Therapeutics
A new mouse model developed by scientists at the U.S. Food and Drug Administration may help in exploring the potential activity of Zika virus vaccines and therapeutics.  

MMWR Articles of Interest

Botulism Outbreak from Drinking Prison-Made Illicit Alcohol in a Federal Correctional Facility
On June 9, 2016, the Mississippi Poison Control Center and the Mississippi State Department of Health (MSDH) notified CDC of five suspected cases of botulism in inmates at a medium-security federal correctional institution. By June 10, a total of 13 inmates were hospitalized.

Outbreak of Salmonella Oslo Infections Linked to Persian Cucumbers
Epidemiologic evidence indicates Persian cucumbers as the source of Salmonella Oslo infections in the outbreak detected in April 2016. This is the fourth identified multistate outbreak of salmonellosis associated with cucumbers since 2013. Further research is needed to understand the mechanism and factors that contribute to contamination of cucumbers during growth, harvesting, and processing to prevent future outbreaks.

OTHER INFORMATION AND UPDATES

69th AACC Annual Scientific Meeting & Clinical Lab Expo
July 30-August 2, 2017
San Diego, CA
The online abstract submission system is now open.

Articles of Interest

Second Theranos Lab Failed U.S. Inspection
The Wall Street Journal 
January 17, 2017
Theranos Inc. failed a second major U.S. regulatory inspection of its laboratory facilities, a setback the Silicon Valley blood-testing firm hasn’t disclosed to investors or patients.

Drumpf Defense Nominee James Mattis Resigns from Theranos Board
The Wall Street Journal 
January 5, 2017
Gen. James Mattis, the retired Marine Corps general President-elect Donald Drumpf has picked to lead the Defense Department resigned from the board of embattled Theranos Inc., according to sources.

CDC Keeps Details Secret of Laboratory Mishaps with Deadly Viruses, Bacteria
USA Today
January 4, 2017
After taking nearly two years to release laboratory incident reports requested by USA TODAY under the Freedom of Information Act, the CDC blacked out many details including the types of viruses and bacteria involved in the mishaps and often the entire descriptions of what happened.

Colombia’s Careful Approach Leads to Slower Reporting of Zika-Linked Defects
The Wall Street Journal 
December 29, 2016
Cases of brain abnormalities in babies linked to the mosquito-borne Zika virus have been revised lower in Brazil, but are on the rise in neighboring Colombia.  The divergent figures in the two countries underscore the different approaches health authorities have taken to get a handle on a public health crisis after Zika hit the region this past year.

Medical Detectives Raced to Save a Man from a Rare, ‘Universally Lethal’ Disease

The Washington Post

December 22, 2016

Clinicians took a detailed travel history, admitted him to the intensive care unit as his blood pressure plummeted and ordered blood tests. A sharp-eyed hematology technician discovered when she looked in her microscope that he was suffering from a disease so rare in the United States that it has been seen only 40 times in the past 50 years.


 

 

 

Last modified on Tuesday, 31 January 2017 12:20

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