Navigation Links
'Mad cow' proteins successfully detected in blood

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 w ith 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 res earch efforts into products for our health care providers and clinical laboratory professionals."


'"/>

Source:University of Texas Medical Branch at Galveston


Related biology news :

1. New, automated tool successfully classifies and relates proteins in unprecedented way
2. UWs Rosetta software to unlock secrets of many human proteins
3. Global analysis of membrane proteins
4. UNC plant researchers discover proteins interact to form hair-trigger protection against invaders
5. Researchers develop new method for facile identification of proteins in bacterial cells
6. Hopkins scientists uncover tags that force proteins to cell surface
7. Researchers create functioning artificial proteins using natures rules
8. UCSD discovery may provide novel method to generate medically useful proteins
9. Prostate cancer uses Wnt signaling proteins to promote growth of bone tumors
10. A real time look at interactions between RNA and proteins
11. New evidence questions the simple link between prion proteins and madcow disease
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:3/21/2016)... -- Unique technology combines v ...   Xura, Inc. (NASDAQ: ... communications services, today announced it is working alongside SpeechPro ... particularly those in the Financial Services Sector, the ability ... a mobile app, alongside, and in combination with, traditional ...
(Date:3/15/2016)... March 15, 2016 Yissum Research Development ... technology-transfer company of the Hebrew University, announced today the ... sensing technology of various human biological indicators. Neteera Technologies ... million from private investors. ... the detection of electromagnetic emissions from sweat ducts, enables ...
(Date:3/11/2016)... 2016 --> ... "Image Recognition Market by Technology (Pattern Recognition), by Component ... Deployment Type (On-Premises and Cloud), by Industry Vertical and ... MarketsandMarkets, the global market is expected to grow from ... by 2020, at a CAGR of 19.1%. ...
Breaking Biology News(10 mins):
(Date:5/3/2016)... ... May 03, 2016 , ... ... of Dr. Nancy Gillett to its Board of Directors. Dr. Gillett recently retired ... Corporate Executive Vice President and Chief Scientific Officer. A board-certified veterinary pathologist, Dr. ...
(Date:5/3/2016)... LONDON , May 3, 2016 ... Report Assessing Developers and Producers of Those Competitor Biologics  ... Guide to Companies, Activities and Prospects ,  ... drug companies? And what are their sales potentials? ... There you see results, trends, opportunities and revenue forecasting. ...
(Date:5/3/2016)... ... May 03, 2016 , ... Nashville Fertility ... laboratories. A contingency of reproductive endocrinologists, including Dr. George Hill at ... and to help them build families. , Ovation Fertility is a nationwide network ...
(Date:5/2/2016)... ... May 02, 2016 , ... StarNet Communications Corp, ( http://www.starnet.com/ ) a ... three Secure Remote Desktop modules to its flagship X-Win32 PC X server. The ... servers to the user’s PC over encrypted SSH. , Traditionally, users of PC X ...
Breaking Biology Technology: