SubscribeOne of the outcomes of Operation Desert Storm (ODS) was the recognition that biodetection capabilities on the battlefield needed to be improved. As a direct result, the four services in the United States military (Army, Air Force, Navy, and Marines) began to develop approaches to meet this challenge.
These developments have evolved from the M31 Biological Integrated Detection System (BIDS) system to the Portal Shield ACTD and most currently the Joint Biological Point Detection System (JBPDS). The latter is the most advanced system available, providing automated and reliable operation in environmental extremes with the capability to be operated and monitored remotely.
Battelle has applied its expertise and resources to improving biodetection capabilities since the early 1990’s, working the basic sciences, developing advanced development prototypes, manufacturing and supporting the JBPDS, and producing reagents for current and future systems.
(Battelle has also been leading the development and implementation of advanced alternative testing methodologies. These efforts will be described in a forthcoming article.) The following paragraphs summarize some of the major on-going activities.
Joint Biological Point Detection System (JBPDS)
Whereas shortly after ODS, each of the services developed their individual response to the biodetection threat, by 1996 the concept of a common JBPDS that would meet the needs of all four services evolved.Battelle began working on the JBPDS program in April 1997 and is currently producing systems (in conjunction with General Dynamics Armaments and Technical Products) for fielding applications.
JBPDS is a robust biodetection instrument suite that is fully functional in any environment the armed forces will encounter in their operations.Simple to set up and shut down, the JBPDS provides automatic detection and identification of biological warfare agents in air at very low levels, triggers local and remote warning systems, and communicates threat information over standard military communication systems.
How does the JBPDS operate?Using laser induced fluorescence, the trigger/detector continuously evaluates the atmospheric aerosol background for indicators of potential BW attacks.When the algorithm results indicate the presence of anything of a suspicious nature, the collector/concentrator initiates sampling of hundreds of liters of air per minute and provides a few milliliters of liquid sample which contain the collected aerosol sample.
This sample is evaluated for specific BW agents using handheld assays (similar to pregnancy tests) with an automated reader assembly.If the assay shows a positive, an alarm is sounded and a portion of the collected sample is provided for later analysis at a certified laboratory.The entire operation is automated.
The range of platform applications for the JBPDS includes HMMWV mounted shelters, Naval ships, and freestanding units. A common system architecture allows units to be configured as networked systems, providing biodetection capabilities over large areas, such as air bases.
The events of September 11, 2001, led to an increased awareness of the potential vulnerability of key sites in the United States. Battelle quickly modified the JBPDS to protect such sites. A Homeland Security JBPDS variant has been in continuous operation since December 2001 monitoring the vicinity of the Pentagon. As a result of these efforts, the Government/Contractor team won the FY2002 David Packard Award for Excellence in Acquisition.
Biological Detection Reagents
Battelle develops, integrates, tests and fields breakthrough technologies to create reagent products and detection solutions for its customers.Battelle focuses on its customer’s missions and the complex challenges they face, then team with them to create timely, affordable, and innovative solutions. The Reagent Development Group at Battelle uses world-class science capabilities to leverage emerging technologies into competitive solutions for its customers.
Battelle, in collaboration with its partners, offers a line of licensed qualitative and quantitative biothreat and biosimulant Taqman® PCR reagent kits produced under cGMP conditions and validated in Battelle’s BL3 laboratories.These reagents are designed to be used alone or in custom combinations dependent upon user needs.
Follow on products include custom and preconfigured lyophilized low volume 384 sample screening kits and confirmation kits to allow the user to qualitatively screen multi-samples for the presence of multi-biothreat organisms or quantitatively confirm the presence of multi-targets of a single threat organism against multi-samples.All of these reagents are optimized for Battelle’s licensed real-time PCR platforms.
In related work at Battelle, handheld detection devices are being designed for detection of harmful materials in environmental (food, water, soil, etc.) samples. These efficient, reagent-containing devices do not require laboratory expertise to operate; they have simple, clear readouts; they are low cost; and they accommodate complex sample matrices.An added feature of the device is the sample holdback that allows for later, full laboratory confirmation of the sample contained in the fully enclosed device.
In collaboration with partners, Battelle is also developing a line of serology test kits used to identify individuals infected with and/or immunized against biothreat agents.These FDA-approved kits are intended to be used by the U.S. public health system to improve epidemiology and treatment regimens.
Biological Attenuation Sensor (BAS)
Some equipment configurations being developed for use on the battlefield or to protect U.S. assets at OCONUS installations (for example the use of Portal Shield and JBPDS to protect airbases and ports) may not be ideal for use in Homeland Defense scenarios, particularly where large numbers of sensors are to be deployed and networked.The design of next generation systems need to be more compact, smaller, and use fewer consumables than the systems being deployed.
The current approach to limiting the use of expensive one-time consumables is a front end setup that serves as a trigger when there is high likelihood that a sample needs to be analyzed.
The consumables used in both Portal Shield and JBPDS are handheld assays with a test panel of 10 agents, an approach that can be very costly in large scale fielding.Nucleic-based sensors, which are even higher in sensitivity, are even more expensive.
The ideal approach would be to use a biological monitor to continuously monitor the atmosphere for biological agents, with no need for consumables.Technologies that potentially have such a capability are based on various forms of mass spectroscopy.
However, these sensors have not yet demonstrated an ability to meet biodetection needs in terms of speed or accuracy.Additionally, their acquisition costs would limit the ability to proliferate these devices in the large numbers necessary for large-scale fielding.
With some alternative technologies that use consumables, it is possible to limit the need to change them out until a positive identification is achieved, a condition that would not occur except in the event of a terrorist attack.These technologies can continuously monitor the atmosphere for bioaerosols, but do not need a triggering front end, thus reducing system acquisition costs.
Battelle has begun developing such a system for the Marine Corps’ Chemical and Biological Incident Response Force; the technology is known as the Biological Attenuation Sensor, or BAS.The BAS technology can be used to develop biological detection systems with significant operational cost savings as well as faster and improved detection sensitivities.
An optical waveguide is at the center of the BAS sensing approach.The waveguide is essentially a glass slide through which light is propagated.One surface of the waveguide is treated with immunoassay chemistry to which specific threat agents in a liquid sample attach.An automated optical read head interrogates the waveguides and measures changes in light intensity through the waveguide.No change in intensity indicates a negative test, that is, no agent has attached.A positive test is indicated by a significant change in the optical signal through the waveguide.
Since the capture chemistry on the waveguide surface is not consumed unless the target antigen is present in the sample, the waveguide channel can be subjected to repeated negative assays. The capture chemistry is robust and allows at least 50 and up to as many as 100 tests per channel. Because of this, the cost of operation can be reduced significantly, especially with respect to those platforms that employ single use technologies, such as the lateral flow assay strips (tickets).After the maximum number of tests per channel have been completed, or, after a positive identification, the next fresh channel is made available for testing by electronically switching the laser in the read head.
Battelle has demonstrated the integration of three independent channels on the waveguide.In previous identifier designs, twelve channels have been successfully implemented. Our current BAS work centers on 10 to 12 channels per chip.
The high density of channel integration reduces the overall size of the identifier package, and continues to reduce the cost per test, which we currently estimate less than 10 cents per test.The various channels and chips are designed into a sealed panel that can be dropped and loaded simply into the identifier, and mated to the fluidics by septum-pierced rubber ports.This design allows for a simple user interface and is self-aligning.
The BAS can be designed for a variety of end-use instruments, including a clinical diagnostic device, a handheld point detector, and as part of an autonomous monitoring system.Each end use entails different operating scenarios, such as the mission time, sensitivity, specificity, number of target agents to identify, size and weight constraints, and how the sample will be introduced into the identifier, to name a few.The BAS’ current state is an advanced technology demonstration, and can be configured to many of these operational concepts.
The BAS has been tested against three inactivated agents of biological origin (Bacillus anthracis, ricin, and Francisella tularensis), as well as Bacillus globigii and Ovalbumin.We participated in the Government-sponsored Sixth Joint Field Trials (JFT6) in 2001 and performed well in the immunoassay class of devices.
Development since 2001 has shown sub-nanogram identification of Ovalbumin in less than one minute, which is a significant improvement over current assay times of 10 to 15 minutes.Due to its promise for improvements in speed and sensitivity, as well as its advantages in operational costs, we believe the BAS is a viable technology to consider in biosensor applications.
Battelle has been involved in a variety of biodetection programs since Operation Desert Storm including the development and production of JBPDS, the most tested biodetection system currently being fielded by the military.
Battelle’s contributions have ranged from basic science, system and related engineering disciplines, and limited production.Associated with the fielding of biodetection systems, these systems need to be tested to confirm the compliance with stated performance requirements.Typically, this testing has either been laboratory testing or field-based operational testing.Battelle has developed alternative testing methodology that has yielded cost-effective testing of systems and components.This testing will be highlighted in a subsequent article.
