Technical Bulletin 4: Evaluating Product Claims - Guardian R1000 Operation Manual

To: All Guardian BioThreat Alert™ Customers
Subject: Evaluating Product Claims
Date: 7 November 2002
In response to numerous dubious claims being made by competitors in the biological
threat field-test market, the management of Alexeter Technologies would like to take the time
to address areas of possible confusion.
1) Which System? Field Performance is the Ultimate Judge of Product Accuracy.
Although laboratory results are important for predicting the performance of equipment in
the field, experienced equipment manufacturers know that until their new equipment is tested
in the field under real conditions, system accuracy, and ultimately the utility (usability) of
cannot be reliably estimated. Critical beta field-testing typically uncovers design flaws or
shortcomings not anticipated by system developers.
Because of this, anyone considering purchase of new equipment should examine both
the laboratory and the field data results from manufacturers before making decisions.
Performance claims from manufacturers based solely on laboratory results or meager field
tests do not always reflect the expected performance of equipment under "real world"
conditions. In the case of the Alexeter's Guardian Reader System, our field data surveys
from use over the last several years indicate a false-positive rate of less than 0.2% under
"real-world" conditions.
Although individual user results may vary, our exceptional field performance is due in no
small part to our focused efforts to design and develop equipment specifically for biological
field-testing. Unlike some competitive systems that are simply medical laboratory devices
hastily retrofitted for field use after last September 11
Tetracore's BioThreat Alert Tests were designed specifically for use by first responders in the
field. Extensive beta field-testing prior to market release, with 8 different HAZMAT teams,
proved that our system delivers optimal performance for the first responder
2) Apples and Oranges: Confusion over System Sensitivity
Since competing test devices often require different sample volumes, sensitivity levels
for analytical detectors or laboratory devices are typically compared by minimum detectable
concentration, e.g. parts per billion (ppb), grams/ milliliter (g/ml), etc. The total amount of a
test substance, i.e., "anthrax spores", does not allow for an accurate comparison of one
device to another any more than claiming you are rich because you earned $100,000. Was
the $100,000 earned in one day or 10 years? The "concentration" makes a big difference.
As demonstrated in Table I below, a claim of having a device that can detect 4000
spores (Product 1) is misleading if the volume for the test is not defined. If Product 1
requires 4,000 spores in a 0.040 ml Sample Volume and Product 2 requires 12,000 spores
Alexeter
Technical Bulletin #4
Alexeter Technologies, LLC
830 Seton Court, #6, Wheeling, IL 60090
phone: (847) 419-1507 fax: (847) 419-1648
www.alexeter.com
Technologies, LLC
th
, the Guardian Reader System and
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