This was MAY 2001 ....

Dr. Breeze's ProMed posting from May 2001:
Archive Number 20010520.0981
Published Date 20-MAY-2001
Subject PRO/AH> Foot & mouth disease, preparedness - USA (10)

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Foot & mouth disease, preparedness - USA (09)  20010518.0974

Date: 18 May 2001
From: Roger Breeze < <>>

FMD virus, new field test - USA
There have been media reports of a new test for foot and mouth disease
(FMD)virus developed by the Agricultural Research Service (ARS) of the
U.S.Department of Agriculture (USDA).  ARS has such an assay, but
believes that the proper time and place to discuss its potential use,
capabilities and implications are after the details and supporting data
have appeared in a peer-reviewed scientific journal.  However, given the
intense current interest in the disease, and the speculation in various
media, we believe it would be helpful to provide an outline.

ARS has been developing a uniform system for detection and identification
of important animal and plant pathogens, some of which are zoonotic
agents of public health significance.  This system relies on standardized
reagents designed to work on a common device platform for all assays --
several devices are already commercially available and others are close
to production.  These devices offer rapid real-time detection and
identification by polymerase chain reaction (PCR) assays, are designed
for use on farm at the site of the problem as hand-held or portable
units, and communicate real-time data via the Internet to those who need
to know in order that immediate action can be taken.

ARS is cooperating with the U.S. Centers for Disease Control and
Prevention (CDC), the Department of Defense (DoD) and others to ensure
the technology is available to support a seamless federal assay system
using standard reagents, protocols and devices that can be implemented
nationwide and globally to detect the most important pathogens of humans,
animals and plants.  The system is specifically intended to support
immediate detection on-site by operators with limited training, not just
by highly-trained personnel geographically restricted to centralized

In cooperation with other federal agencies, academia and private
industry, ARS is developing reagents and protocols for detection and
identification of all List A and B diseases of animals, for food-, water-
and vector-borne diseases and for important plant diseases whenever this
is possible through nucleic acid detection.

ARS now has assays in its research laboratories for several List A and B
pathogens, including FMD virus.  The FMD assay requires minimal sample
preparation and results are available in less than 2 hours after
collection.  The assay detects all 7 FMD virus serotypes and
differentiates the virus from near relatives and from swine vesicular
disease, vesicular exanthema and vesicular stomatitis viruses.  In
experimentally-infected animals, FMD virus can be detected well before
the onset of clinical signs of disease.

Each assay procedure can be followed and verified over the Internet by
experts at distant sites as successive amplification steps take place:
instead of taking the sample to the expert in a central laboratory, the
system takes the analytical data from the farm to the expert, so that any
comment can be immediately returned to the person performing the analysis
on the site.   The system thus offers a time saving of at least 24 to 48
hours in definitive detection of virus.  If time is gained, multiple
alternate courses of action become possible for those charged with
controlling the disease outbreak.  This is the true significance of the

The next stage of research is to validate the assay and the device
platform on the farm as a means to identify animals infected with foot
and mouth disease virus.  Such on-farm validation studies have never been
done previously because portable PCR technology was not available.  ARS
is planning experiments in several countries to acquire these data,
because foot and mouth disease does not occur in the United States.  The
goal is a validated PCR test for foot and mouth -- and for all other List
A and B diseases -- that could be employed on the farm rather than in a
central laboratory: this would offer new approaches to disease control
for regulatory authorities in countries where this disease occurs.

Currently, there are no PCR tests approved by the International
Organization of Epizootics (OIE) for diagnosis of FMD.  Our research task
will be completed when we have delivered to the US and international
animal health community a suite of OIE-approved real-time diagnostic
assays for the most important global animal disease threats.

Roger Breeze, BVMS, PhD, MRCVS
Associate Administrator
Agricultural Research Service, U.S. Department of Agriculture
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