Principles Of The Immunoassay Test Strip; Principles Of The Guardian Reader - Guardian R1000 Operation Manual

using the same proven methods have been employed for over twenty
years in the medical diagnostic's industry. The System is comprised
of disposable, single-use test strips and the portable test strip analyzer
(the Guardian Reader manufactured exclusively by Alexeter Technolo-
gies).

Principles of the Immunoassay Test Strip

Note: Always refer to the test strip's package insert for the latest prod-
uct information!
The Test Strip is a rapid qualitative test (or assay) to detect the
presence of biological threat agents in aqueous environmental samples.
See the "System Features" section, below, for a complete list of tests
available.
The test utilizes a combination of monoclonal and polyclonal an-
tibodies to selectively detect the presence of biological threat agents in
aqueous samples. The test is conducted by dispersing the suspect mate-
rial in Bio Detect Sample Buffer™, then adding this mixture into the
test strip sample port and observing for the formation of colored lines.
At the beginning of the test, the antibody colored conjugate
migrates via capillary action along the membrane, reaching antibodies
immobilized in two areas on the membrane. A positive specimen reacts
with this biological agent-specific conjugate and forms a colored line
in the sample area of the test strip. This is the sample line. The ab-
sence of this colored (sample) line indicates a negative result. To serve
as a control for the procedure, a colored line in the control area must
always appear regardless of the absence or presence of specific bio-
logical agents in the sample. This is the control line. No test may be
considered valid without the presence of the control line. See Figures
1& 2 and also the "Interpreting Your Results" section, below.

Principles of the Guardian Reader

The Guardian Reader is a precision analytical instrument may be
operated in either of two modes; Manual Test mode or Automatic Test
mode.
In Manual Test mode, the test strip is inserted into the Reader 15
minutes after the sample was added to it. This is called a "dosed" test
strip. In Automatic Test mode, a fresh, unused ("undosed") test strip in
inserted into the Reader. The Reader will then direct the user with step-
by-step instructions on the screen. As the last step in either mode, the
Guardian Reader will analyze the test strip and report the results.
The Guardian Reader uses an optical diode-array detector to rap-
idly determine the test result by measuring the line density across the
Test Strip. The resulting sample value is compared to a programmed
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