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Hand-held
assays (sometimes referred to as “Smart Tickets”) are sold
commercially for the rapid detection of Bacillus anthracis.
These assays are intended only for the screening of environmental samples.
First responder and law enforcement communities are using these as
instant screening devices and should forward any positive samples to
authorities for more sensitive and specialized confirmatory testing.
The results of these assays should not be used to make decisions about
patient management or prophylaxis. The utility and validity of these
assays are unknown.
At this
time, CDC does not have enough scientific data to recommend the use
of these assays. The analytical sensitivity of these assays is limited
by the technology, and data provided by manufacturers indicate that
a minimum of 10,000 spores is required to generate a positive signal.
This number of spores would suggest a heavy contamination of the area
(sample). Therefore a negative result does not rule out a lower level
of contamination. Data collected from field use also indicate specificity
problems with some of these assays. Some positive results have been
obtained with spores of the non-anthrax Bacillus bacteria
that may be found in the environment.
For these
reasons, CDC has been asked to evaluate the sensitivity and specificity
of the commercially available rapid, hand-held assays for B. anthracis.
When this study is completed, results will be made available. Conclusions
from this study are not expected in the near future.
Distributed via Health Alert Network
October 18, 2001, 21:30 EDT (9:30 PM EDT)
Priority: Medium
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