Originally Published IVD Technology
March 2003
INDUSTRY NEWS
Laboratories step up to the front line of national defense |
Diagnostic laboratories are participating in a multi-million dollar surveillance effort designed to alert the United States to a bioterrorism attack. Newly modified Environmental Protection Agency (EPA) air monitors equipped with pathogen filters are scanning the air for bioterrorism agents.
The air-monitoring system, dubbed Bio-Watch, relies heavily upon the work of 120 laboratories within the Laboratory Response Network (LRN), a national network of CDC-affiliated laboratories. The LRN will use polymerase chain reaction (PCR)-based testing to scan the air-monitor filters on a regular basis for smallpox, anthrax, and other dangerous pathogens. Ideally, Bio-Watch will detect a bioattack before victims show symptoms.
Along with the air-monitoring system, a computerized health-monitoring network will alert public health officials to a terrorism-related germ attack. Laboratory test requests, along with illness symptoms reported to doctors, drugstore sales records, and calls to poison control centers are among the data gathered by the network. The network may eventually incorporate information on absenteeism at work, veterinary visits, and sales of over-the-counter medications into its analysis.
The surveillance systems will not detect an attack until after a biothreat agent has been released. However, delivering treatment even a day or two earlier than would be possible without surveillance could substantially lower death rates.
Even if the system never detects an actual biological attack, a national germ- and disease-monitoring system will be of great value. David Fleming, CDC’s deputy director for public health science, noted that “even if there is never another bioterror incident, this system will help us with the day-to-day business of responding to traditional diseases.”
The computer network depends upon electronic connectivity to gather its data; however, recent studies revealed the inadequacy of information management systems in many state laboratories. Among the unresolved datamanagement issues is the fact that many laboratories are unable to electronically communicate directly with CDC. Several laboratories rely on telephone and fax to deliver and receive test results, thereby delaying the deployment of medical treatment when needed.
The inability to scan air inside indoor public areas is an additional weakness of the national bioterror-attack monitoring system. Such monitoring technology exists, but the systems are either still in development or are too expensive to be distributed and employed nationally.
The Department of Energy’s Lawrence Livermore National Laboratory (LLNL; Livermore, CA) has developed a system for PCR-based continuous automated indoor air monitoring called the Autonomous Pathogen Detection System (APDS). Richard Langlois, PhD, senior biomedical scientist at LLNL, states that the APDS will likely be incorporated into the national bioterror-monitoring system in the near future. Several prototype units have performed successfully, and the system is in the process of being licensed to a major corporation for commercial production.
Protection of the U.S. food supply from intentional contamination is also in need of improvement. In its newly published guidance to minimize terrorist threats to food, the World Health Organization calls for countries to strengthen their food surveillance systems “to allow rapid detection of food terrorist incidents.”
One suggested method of early and rapid detection is routine monitoring for chemical, biological, and radionuclear contaminants in food at the food production and process stages. The guidance calls for the IVD industry to aid in rapid response, stating that diagnostic laboratories “must have appropriate expertise and analytical methods in place to detect chemical, biological, and radionuclear agents in food and human samples.”
Ground surveillance for germ agents will be accomplished by many rapid and portable IVD-based detection systems that will screen suspicious substances on-site. The BioCheck powder-screening kit, manufactured by 20/20 GeneSystems Inc. (Rockville, MD) is one of several primary screening tests that can quickly detect the presence of protein in a suspicious powder, and either immediately allay suspicion of terrorism or determine that more-specific tests are warranted.
The Pacific Northwest National Laboratory has developed the technology behind a more specific method of testing. This new portable mass spectrometer uses matrix-assisted laser desorption/ionization mass spectrometry to analyze samples. The device is in the late stages of development and can be used on-site to identify biological terrorist agents within 5 minutes. LLNL has also developed a point-of-care pathogen-detection device that uses PCR-based technology to analyze four samples at once and provide accurate results in as few as 10 minutes. Weapons inspectors in Iraq are using this device, called the Handheld Nucleic Acid Analyzer, to search for evidence of biological weapons.
The April issue of IVD Technology will further explore and examine the development of diagnostics for
biodefense.
Copyright ©2003 IVD Technology
