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Alexeter Technologies has recently obtained copies of
a public presentation presented at last year's American Society of Microbiology annual
conference1. Below is a slide taken
from the presentation highlighting that 75% ( 6 out of 8) of
near-neighbor bacillus (NN) tests by the two CST teams gave false positive
results. Many other tests results from the same trial failed to give
any result and were scored as "not reported". Disturbingly, such questionable performance
results have never been released by the AOAC and have in
fact been ignored by funding officials at the DHS. Since AOAC can only
maintain funding streams from the DHS if studies continue, and no studies could continue
to field trials if all technologies failed to get certified in tests, the
question is raised whether the AOAC may have a conflict of interest in making
the decision on which data should be "ignored". However,
playing by the rules doesn't seem to matter to the AOAC management in this process.
These results lend support
to ongoing concerns that the AOAC lab protocols do not challenge the test
systems with "real world" amounts of spore powders. The level of anthrax
false-positives reported by the CST operators on the RAMP system mirrors the levels of
false positives reported by the Center for Disease Control studies conducted in
the FBI-sponsored tests in 2002 (41%), lending further credence to questions on
AOAC methods. It should be noted that the AOAC has disavowed the CST tests
as being "not well thought out" and has refused to release
the data to other participants. Unfortunately for AOAC and RAMP the information is now public.
Meanwhile, the RAMP system has been foisted upon the HAZMAT community by AOAC
and DHS as a rigorously-tested field system. Further ignored by the AOAC
and DHS is that the RAMP system DOES NOT meet any reasonable concept of
operations for HAZMAT response. Little advertised by Response Biomedical,
but well known to its users, is that the RAMP system takes over 20 minutes to
conduct a single test. Thus, testing for only FOUR biological agents
entails over 80 minutes of testing, let alone adding in the testing time for
chemical, explosive or radiological threats. Clearly, the RAMP is a system
that, at best, should be left in the laboratory. Based upon its field
performance, laboratories may have reasons to raise questions about the RAMP
accuracy.
With respect to the recent AOAC announcement that the
RAMP system has been certified for field use, it should be noted that AOAC
refuses to release any data or protocols of the testing that was performed in
the laboratories of the Dugway Proving Grounds (DPG). Thus, the rules
of the game have been yet again changed by AOAC to ensure that the RAMP system
was "certified" as field ready in the absence of customary committee
review of protocols and methods. We have been informed by the AOAC that tests
were completed under the direct and "active" supervision of training personnel from
DPG and on samples from trace amounts of bacillus powders (below levels
typically found and below levels that the RAMP system gives false-positives).
Beyond this so-called "rigorous field test" format, failed tests on the RAMP
system (better than 50% in CST testing) were ignored in evaluating the test
data. Finally, users has access to multiple RAMP instruments and could run
multiple tests simultaneously, alleviating the wait times a typical HAZMAT team
would encounter. The question is not whether RAMP passed the so-called
"field tests" but in fact was there any possibility in which this dubious test
protocol could have failed the RAMP instrument? We think the answer is
obvious as any HHA system could have passed this test.
Alexeter has remained at the forefront of exposing
this embarrassment, calling for an investigation in the mismanagement of this
process by the Department of Homeland Security. In addition to the waste
of taxpayer funds, the DHS has allowed this pseudo-scientific effort to continue
unabated. We can only assure our loyal and concerned customers that
we will continue the fight to maintain quality in the field testing arena,
regardless of the political ramifications.
1Hand-Held Assays, M. Pentella, 105th General Meeting American
Society of Microbiology, Atlanta, GA, June 2005.
Background: AOAC International received a $2.6 million contract from the
Department of Homeland Security (DHS) in June of 2003 to develop test methods
for lateral flow immunoassays, also known as hand-held assays (HHAs). Both
commercial and federal HHAs were to be tested in the study. Shortly thereafter,
methods standards were written and agreed to by all parties. Unfortunately, in
September 2003, the AOAC made a unilateral decision (called Amendment 1)
that changed the agreed-upon method standards by allowing each product tested to
be treated with unequal concentrations of bacterial spores. This illogical
modification was made presumably to adjust for the varying sample volumes for
testing for each product (Click
here to read the changes detailed in Amendment 1). Thus each
product was given a differing concentration of bacterial spores.
This
change in protocol largely invalidated any meaningful conclusions from the AOAC
study. By varying concentrations, the AOAC removed any possibility of
comparing test results across products. As a direct consequence of Amendment 1,
US military scientists notified AOAC in November 2003 of their intention to
withdraw from the trial stating that, "Due to its design, the AOAC study does
not provide the end user with an accurate assessment of the capability of the
assays...we see little value in the study".
(Click here to see the full text of
the letter). Since that time, scientists have met numerous times with both the
AOAC and government officials to correct the protocols. Unfortunately, those
efforts were ignored or rebuffed.
Analysis: Scientists both within and outside the US government had raised
numerous concerns over the lack of scientific rigor in the AOAC test methods
over a year ago. Requests for an independent review of the test methods were
ignored and the AOAC proceeded with complicity from federal officials in the
Department of Homeland Security.
Continued protests from commercial companies on specific
deficiencies in the test methods continue to be ignored despite the
authoritative conflicting data presented to AOAC. The most striking aspect of
the current test results are that they completely contradict the CDC study from
2 years ago. It was that very CDC study which formed the basis for the original
criticisms of HHAs. How does one deal with contradictory studies that the
federal government produces and stands by? Is one study is “more correct”?
Should either study be trusted?. These questions are impossible to address
currently since the federal authorities are now claiming (again) that the test
methods will be kept restricted.
Conclusions: It has been nearly 5 years since the anthrax letter
attacks. Emergency responders still await any constructive advice from federal
health authorities. Current federal health authority recommendations are to
test for everything BUT biologicals and then give the sample to the FBI for
laboratory testing. Experienced responders realize that the laboratory response
network will never be able to accommodate in a timely manner the number of
samples that would result from another public biological attack.
With
respect to our current products, meticulous independent data collected to date
clearly supports the reliability and accuracy of the Alexeter and Tetracore anthrax products
for field detection. More importantly, our performance in actual field use
demonstrates our claims regarding the
effectiveness of our products . Alexeter stands ready to provide supporting
data to any interested party. We are exceedingly confident that these facts
will be self-evident when subjected to an impartial and scientifically valid
forum. As we move forward, our customers should be assured that Alexeter will
continue to provide cost-effective technology and proven expertise dedicated to
the defense of our communities and the nation.
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