XML Feed for RxPG News   Add RxPG News Headlines to My Yahoo!   Javascript Syndication for RxPG News

Research Health World General
 
  Home
 
 Latest Research
 Cancer
 Psychiatry
 Genetics
 Surgery
 Aging
 Ophthalmology
 Gynaecology
 Neurosciences
 Pharmacology
 Cardiology
 Obstetrics
 Infectious Diseases
  AIDS
  Influenza
  MRSA
  Tuberculosis
  Shigella
  HCV
  SARS
  Ebola
  Dengue
  Malaria
  Pertussis
  Mumps
  Prion Diseases
  Small Pox
  Anthrax
  Leishmaniasis
 Respiratory Medicine
 Pathology
 Endocrinology
 Immunology
 Nephrology
 Gastroenterology
 Biotechnology
 Radiology
 Dermatology
 Microbiology
 Haematology
 Dental
 ENT
 Environment
 Embryology
 Orthopedics
 Metabolism
 Anaethesia
 Paediatrics
 Public Health
 Urology
 Musculoskeletal
 Clinical Trials
 Physiology
 Biochemistry
 Cytology
 Traumatology
 Rheumatology
 
 Medical News
 Health
 Opinion
 Healthcare
 Professionals
 Launch
 Awards & Prizes
 
 Careers
 Medical
 Nursing
 Dental
 
 Special Topics
 Euthanasia
 Ethics
 Evolution
 Odd Medical News
 Feature
 
 World News
 Tsunami
 Epidemics
 Climate
 Business
 
 India
Search

Last Updated: Nov 18, 2006 - 12:32:53 PM

Anthrax Channel
subscribe to Anthrax newsletter

Latest Research : Infectious Diseases : Anthrax

   DISCUSS   |   EMAIL   |   PRINT
Diagnostic method for identifying Bacillus anthracis receives FDA approval
Aug 30, 2005 - 8:56:00 PM, Reviewed by: Dr.

"This represents a very significant milestone for both of our organizations, in that all of the medical diagnostic products that we are developing must eventually follow a similar pathway for approval to allow clinical diagnosticians to use these tests to positively identify pathogens"

 
A method for identifying Bacillus anthracis, the causative agent of anthrax, has been cleared for diagnostic use by the U.S. Food and Drug Administration (FDA). The test, known as the Gamma Phage Assay, was modified by scientists at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to improve its performance and reliability when used with clinical specimens. The original form of the Gamma Phage Assay was first developed by the Centers for Disease Control and Prevention (CDC) in the mid-1950s.

The modified gamma phage method is the first diagnostic test to gain FDA approval for human use within the Laboratory Response Network (LRN). This network, established by the CDC, is charged with maintaining an integrated system of state and local public health, federal, military, and international laboratories that can respond to bioterrorism, chemical terrorism and other public health emergencies.

According to USAMRIID senior scientist John W. Ezzell, the Gamma Phage Assay is a classical bacteriological method that has been used at USAMRIID and other laboratories for years as part of an extensive array of methods used to identify B. anthracis. The gamma phage is a virus capable of entering bacterial cells and causing cell destruction, or lysis--and it is specific to B. anthracis.

"Because of that specificity, the gamma phage gives a highly readable result," Ezzell explained. "Wherever the virus is added to the surface of a culture plate that has been inoculated with suspicious anthrax colony growth, you can see clear zones where the B. anthracis cells have been destroyed--whereas other bacterial cells grow unaffected."

Well before the anthrax attacks of 2001, scientists at USAMRIID and the CDC recognized the need for an FDA accepted method for identifying B. anthracis in clinical specimens. In 2002, FDA's Division of Clinical Laboratory Devices agreed to recognize tests for B. anthracis as eligible for classification with a 510(k) premarket notification process--the designation given to devices and other non-biologics.

USAMRIID, with support from CDC, prepared and submitted a 510(k) Premarket Notification using both USAMRIID and CDC data on use of the gamma phage method. With FDA recognition of the assay as substantially equivalent to the classical assay used prior to 1976, it will be available for use for testing in designated civilian and military clinical laboratories.

"This is a big first step in helping to provide the LRN labs with FDA cleared assays," said Judy Sheldon, a regulatory affairs microbiologist with the CDC's Bioterrorism Preparedness and Response Program. "The work done at USAMRIID and here at CDC provided a solid scientific basis for FDA to evaluate the assay performance. This work has set a high bar for other tests to meet."

USAMRIID scientists standardized and validated the test to make it more rugged, more reproducible across laboratories, and more resistant to user error. They developed a clearly defined method for production of gamma phage that proved to be highly stable, as reflected in the extended shelf life of the B. anthracis-specific virus. USAMRIID then provided sufficient gamma phage material to CDC for distribution within the LRN, so that each laboratory will have the same material to be used in the test. In addition, USAMRIID developed Standard Operating Procedures for the assay to ensure that each laboratory in the LRN will run the test the same way. This also increases confidence in the final result.

"This represents a very significant milestone for both of our organizations, in that all of the medical diagnostic products that we are developing must eventually follow a similar pathway for approval to allow clinical diagnosticians to use these tests to positively identify pathogens," said Colonel George W. Korch, Jr., commander of USAMRIID. "Successes such as these demonstrate that we can translate our research efforts into products for our health care providers and clinical laboratory professionals."
 

- A study to document and validate the performance characteristics of the assay will be published in the September 2005 issue of the Journal of Clinical Microbiology. In the paper, authors Terry G. Abshire, J. Edward Brown, and John W. Ezzell of USAMRIID also describe how they standardized production of the phage and determined the stability of the assay.
 

US Army Medical Research Institute of Infectious Diseases

 
Subscribe to Anthrax Newsletter
E-mail Address:

 

About USAMRIID
USAMRIID, located at Fort Detrick, Maryland, is the lead medical research laboratory for the U.S. Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. The Institute's mission is to conduct basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command.

About the CDC
The CDC is one of the 13 major operating components of the Department of Health and Human Services (HHS), which is the principal agency in the United States government for protecting the health and safety of all Americans and for providing essential human services. Since it was founded in 1946, CDC has remained at the forefront of public health efforts to prevent and control infectious and chronic diseases, injuries, workplace hazards, disabilities, and environmental health threats.

On the web:
www.usamriid.army.mil
www.cdc.gov


Related Anthrax News

Monoclonal antibody recognizes a specific sugar on the surface of anthrax bacteria spores
Scientists design functionalized liposome - a potent anthrax toxin inhibitor
PlyPH protein kills anthrax bacteria by exploding their cell walls
Surprising new insights about the acid pH levels required for anthrax toxin
Diagnostic method for identifying Bacillus anthracis receives FDA approval
Protective Antigen Ion Channel Asymmetric Blockade To Detect Anthrax Infection
ABthrax(TM) Safe and Effective against Anthrax
DNI - Newly Identified Inhibitor of Anthrax Toxin May Contribute to Postexposure Therapy


For any corrections of factual information, to contact the editors or to send any medical news or health news press releases, use feedback form

Top of Page

 

© Copyright 2004 onwards by RxPG Medical Solutions Private Limited
Contact Us