The Guardian Reader

The Guardian Reader is a portable biological agent identification and documentation screening system. It is intended for use by trained personnel and only for use in the field to perform rapid analysis on environmental samples that may contain potential biological threats. 

 

Summary and Explanation of the Test System:  The Guardian Reader System employs unique biological reagents ( antibodies ) for the detection and identification of biological agents in conjunction with an analytical measuring instrument, using the same proven methods have been employed for over twenty years in the medical diagnostic’s industry. The System is comprised of a disposable, single-use test cartridge called the Bio Threat Alert Test Strip, and the portable test strip analyzer which is the Guardian Reader itself. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect the presence of biological threat agents in aqueous samples. The test is conducted by adding a sample of the suspected material into the test strip sample well and then observing for the formation of colored lines ( see live example at the bottom of the pages). At the beginning of the test, the sample migrates via capillary action along the membrane, reaching the antibody-colored conjugate. A positive specimen reacts with this biological agent-specific conjugate and forms a colored line in the S (sample) area of the test strip. The absence of this colored line indicates a “Negative” result. To serve as a control for the procedure, a colored line in the C (control) area must always appear regardless of the absence or presence of specific biological agents in the sample. No test may be considered valid without the presence of the control line. See Figure 1 and the “Interpreting Your Results” section, below.

 

Principles of the Guardian Reader:   The Guardian Reader may be operated in either 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 “ strip. In Automatic Test mode, a fresh, unused (“undosed”) test strip is inserted into the Reader. The Reader will then give the user 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 rapidly determine the test results by measuring the line density across the entire Bio Threat Alert Strip. The resulting sample value is then compared to a pre-programmed threshold value that is stored in non-volatile memory in the test cartridge or in the Reader. If the sample value from the test is determined to be above the threshold value, a POSITIVE test result is displayed and the Reader’s audio alarm will sound. The Guardian Reader provides more objective results than the human eye can, especially under difficult lighting conditions or when low concentration of the biological agent is present.

 

The complete Guardian Reader System includes The Guardian Reader with integrated printer, AC adaptor, watertight carrying case and on site training.

 

Operation Outline:

Upon Startup and Automatic internal calibration, the Guardian Reader prompts the user for Sample ID information and Reading Mode (Manual or Automatic).

After applying sample, the Bio Threat Alert™  Test Strip is inserted into the Guardian Reader.  The Guardian Reader begins operating after User presses "Start". 

The Reader automatically scans the Radio-Frequency ID (RFID) chip embedded in the Bio Threat Alert™ Test Strip and verifies the Test Type and calibration data for the particular Test Type and Lot.

After 2-3 minutes (in Manual Mode; AUTO Mode read time is approximately 15 minutes), the Reader automatically reports results on the LCD Display and Prints a report to the Personal Printer. Data displayed includes: Test Type, Result (Positive or Negative), Date/Time, Sample ID.

Results are simultaneously saved into internal memory for recall later or for downloading to a computer for backup.

Each Bio Threat Alert™ Test Strip is individually serialized for chain-of-custody and forensic documentation.  

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