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Volume 10, Number 1—January 2004
Research

Evaluating Detection and Diagnostic Decision Support Systems for Bioterrorism Response

Dena M. Bravata*†Comments to Author , Vandana Sundaram*†‡, Kathryn M. McDonald*†, Wendy M. Smith*†, Herbert Szeto*†§, Mark D. Schleinitz¶#, and Douglas K. Owens*†‡
Author affiliations: *University of California San Francisco-Stanford Evidence-based Practice Center, Stanford, California, USA; †Stanford University School of Medicine, Stanford, California, USA; ‡VA Palo Alto Healthcare System, Palo Alto, California, USA; §Kaiser Permanente, Redwood City, California, USA; ¶Rhode Island Hospital, Providence, Rhode Island, USA; #Brown University School of Medicine, Providence, Rhode Island, USA

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Table 2

Evaluation data for detection systems for bioterrorism agentsa

System name Purpose Evaluation datab
Anthrax Sensor (7) A portable detection system for “highly sensitive detection of biological agents within seconds” (7). Reported to be capable of detecting endotoxins at a level that is “20 times lower than previously achieved by similar devices” (7).c
BioCapture (8) A portable collection system for use by first responders. Was compared to an All Glass Impinger (AGI) that collects samples into liquid and a Slit Sampler that impacts bacteria directly onto growth media and found to have a collection efficiency of 50%-80% relative to the AGI and 60%-125% relative to the Slit Sampler (8).c
Digital Smell/Electronic Nose (9) To detect and classify microorganisms according to the volatile gases given off during metabolism. An array of 15 sensors was able to correctly classify 68 of 90 colonies containing 0 or 1 of 5 test organisms and an uninoculated control; however, it registered 22 of 90 as false-positives (9).
Fluorescence-based array immuno-sensor (10) To provide simultaneous, antibody-based detection of bioactive analytes in clinical fluids. Bioterrorism agents intended to be detected include Staphylococcus enterotoxin B and F1 antigen from Yersinia pestis. It was unable to detect S. enterotoxin B levels (<125 ng/mL) in experimentally spiked urine, saliva, and blood products; sensitivity for F1 antigen from Y. pestis was reported at 25 ng/mL (10).
LightCycler; Ruggedized Advanced Pathogen Identification Device (RAPID) (11) LightCycler uses a PCR cycler for “real-time” quantification of DNA samples. RAPID is a rugged, portable system that uses LightCycler technology for field detection of bioterrorism agents. RAPID is reported by the manufacturer to be 99.9% specific (11). For each assay, the sensitivity is set to half the infective dose (for example, the infectious dose of foot and mouth disease is 10 virus particles; RAPID’s sensitivity is set to detect 5 virus particles [11]).c
MiniFlo (12) For rapid, portable detection of multiple biological agents using flow cytometry. Detected 87% of unknown biological agent simulants, including agents similar to anthrax and plague, with a false-positive rate of 0.4% (12). Bioterrorism agents identifiable: Y. pestis and Bacillus anthracis, as well as other viruses, bacteria and proteins (12 ).
Model 3312A Ultraviolet Aerodynamic Particle Sizer (UV-APS) and Fluorescence Aerodynamic Particle Sizer-2 (FLAPS-2) (13) To detect living organisms in aerosols and nonvolatile liquids. FLAPS-2 was able to detect 39 of 40 blind releases of stimulant aerosols (of particle ranging in size from 0.5 to 15 μm) at a distance of about 1 km with no false alarms during a 3-week period. In another trial, it was able to detect as few as 10 agent-containing particles per liter of air (13,4).
Sensitive Membrane Antigen Rapid Test (SMART) and the Antibody-based Lateral Flow Economical Recognition Ticket (ALERT) (1417) A handheld antigen/antibody test for the rapid detection of bioterrorism agents. When field tested during the Gulf War, the SMART system had an “alarmingly” high false-positive rate thought secondary to contamination (14). SMART tests are reported per the manufacturer to have a 96% to 99% sensitivity and 94% to 99% specificity for Vibrio cholerae O139 and O1) (1417)

aPCR; polymerase chain reaction.
bWhere possible, we report sensitivity and specificity data (and highlight them in bold); if the published reports did not provide these values directly but did provide sufficient data for them to be calculated, we performed these calculations.
cDenotes systems for which available evaluation data were from manufacturers’ Web sites only.

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