|
Be an
Educated User: Comparing Systems and Cutting Through All of the Hype
Source: Alexeter Technologies.
Cont'd... |
The important point is that the customer needs to demand from
the manufacturer what concentration is required to detect the
target substance. Otherwise, it will be impossible to determine
“apples from oranges”.
|
Table 1: Detection Level v.
Sample Amt |
PRODUCT 1 |
|
PRODUCT 2 |
|
Amount (spores) |
4000 |
4000 |
4000 |
12000 |
12000 |
12000 |
|
Sample Volume (ml) |
0.040 |
0.080 |
0.120 |
0.040 |
0.080 |
0.120 |
|
Detectable Sensitivity
(spores/ml) |
100,000 |
50,000 |
33,333 |
300,000 |
150,000 |
100,000 |
FACT: When comparing
concentration sensitivity, there is no commercial antibody test
system more sensitive than the Guardian Reader System.
3
| Be
Wary!
"Lethal Dose” in
Environmental Field-Testing
For biological environmental testing, since a lethal dose is impossible to see
with the naked eye, failure to detect a lethal dose amount does not
ensure that a lethal dose is not present elsewhere in the immediate environment.
This is why current technologies are not recommended by health
authorities for so-called “trace analysis”.
Scattered spores may be present throughout an area but missed in
collecting the trace sample.
The
best uses for biological environmental tests are for analysis of visible
samples. In these cases, substances
are at sufficiently high amounts that there can be no question of whether the
test has adequate sensitivity. Claims
by some competitors of below lethal-dose sensitivity mislead the user into
believing an entire area is free from toxic substances when the results can only
be used to assure the limited area sampled (table-top, desk top, etc.) did not
produce a positive sample.
4 |
Don’t be
Misled ... by “FDA-approval” claims.
The U.S. FDA offers marketing approval for medical and
clinical devices, not environmental field-testing equipment. This is due to the
vast differences between laboratory testing and field-testing. Technology
developed for medical offices or clinical laboratories requires features and
performance guidelines that are not designed for field-testing.
A device that is designed for the emergency room use for testing
patient’s blood is unlikely to have features relevant for hazmat technicians. This is
the reason that very few laboratory devices have transitioned into the field.
As such, an FDA-standard for lab performance tells the user very little
about how the device will work under field conditions.
Users should confirm that any device they employ meets approved good
manufacturing standards (e.g., GMP or ISO9002) and that field evaluations have
been conducted. The extra homework
required to investigate a particular device will be well
worth the effort.
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|
BE
AN EDUCATED USER
| In response to
numerous dubious claims being made by competitors in
the biological threat test [field, we] would like to
clear up some confusion.