|
FBI/CDC
Results Released from Recent Study on Rapid, On-Site Anthrax and Plague
Tests
Source: Federal Bureau of
Investigation/Centers for Disease Control.
10.31.02 |
The FBI & CDC recently released results from a joint study they
conducted on rapid, on-site biological tests.
Background:
Federal memoranda
released on July 21, 2002 advised First Responders not to use
hand-held anthrax and plague tests for field evaluation of suspected
biological threats. The advisory was based upon recommendations to the
White House Office of Science and Technology Policy (OSTP).
This followed a Department of Health & Human Services' (DHHS) internal
review of test data produced from an FBI/CDC study of commercially available
hand-held tests.
Although the recommendations cited unfavorable test results for ALL
commercially-available anthrax tests, Federal authorities declined to make the
test results, the protocols, or the evaluation standards publicly available.
Alexeter Technologies, LLC and Tetracore, Inc. have worked diligently with
various Federal agencies to obtain release of the test report for independent
review.
Test Results:
We have finally obtained a redacted version of the test results that clearly
indicate that all of the products did not perform equally and that, in
fact, the Tetracore anthrax test outperformed the others by a wide margin.
Tetracore’s plague test also outperformed the only other product evaluated.
In the interest of full disclosure and to allow review by current and
potential users of these technologies, the test data are summarized below.
|
Table 1: Commercial
Anthrax Tests |
|
|
Sensitivity |
Specificity1
(false positives) |
Reproducibility |
Robustness2
With | Without |
|
Tetracore3/1 |
106 |
3% |
98% |
100% |
85% |
|
#2 |
105 |
37% |
90% |
95% |
85% |
|
#3 |
106 |
83% |
94% |
85% |
85% |
|
#4 |
106 |
41% |
78% |
n.d. |
n.d. |
|
Notes:
1 - As determined
across 30 different non-anthrax bacterial species.
2 - Performance
of each test in the presence of additives (interferants);
with or without anthrax (target).
3 - Tetracore
BioThreat Alert tests were read visually; the Guardian
Reader was not used in this study. |
The full test protocols and identities were not included
in the redacted test summary. However, we have confirmed through at least 5 separate and
independent sources that the Tetracore anthrax test outperformed all other
hand-held tests evaluated. Sensitivity was determined by the lowest
concentration that gave ten out of ten positives.
As no tests were performed between 1.0 x 105
and 1.0 x 106 CFU/ml in the CDC test, precise sensitivity between
these concentrations was not determined.
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|
FBI/CDC
STUDY
| A joint study
by the FBI and the CDC was recently completed on the
reliability and accuracy of biological HHAs and
ranked Alexeter's products #1.