Introduction - Abbott SoToxa TOX400PHO User Manual

1 . I N T R O D U C T I O N
The SoToxa™ Mobile Analyser is intended to be used in conjunction with the SoToxa™ Test Kit for screening for the presence of Drugs of Abuse and/or their
metabolites in oral fluid. For professional in vitro use only.
A positive test result should be confirmed by a second test method such as GC-MS (gas chromatography-mass spectrometry) or LC-MS (liquid
chromatography-mass spectrometry).
Please read this User Guide and the Test Kit Instructions for Use carefully, prior to using the analyser.
TOX400PHO | TOX400SHO
1.

Introduction

1.1 Intended use
The SoToxa™ Mobile Analyser is intended to be used in conjunction with the SoToxa Test Kit to screen for the presence of Drugs of Abuse and/or their
metabolites in oral fluid. For professional in vitro use only.
A positive test result should be confirmed by a second test method such as GC-MS (gas chromatography–mass spectrometry) or LC-MS (liquid
chromatography–mass spectrometry).
1.2 Test principle
1.2.1 The SoToxa™ Mobile Test System consists of the SoToxa Mobile Analyser, and the SoToxa Test Kits which contain the SoToxa™ Test Cartridge and the
SoToxa™ Oral Fluid Collection Device.
1.2.2 The analyser is a digital imaging device which uses advanced image processing algorithms to accurately determine the line intensity on the test cartridge.
1.2.3 The test cartridge is a chromatographic immunoassay. This is a single use, disposable cartridge that contains dried reagents and a liquid buffer solution.
1.2.4 The test cartridge is inserted into the analyser and is warmed by the analyser to optimum testing temperature.
1.2.5 Oral fluid is collected using the collection device supplied within the test kit. This is a single use, disposable collection device. The donor must actively swab the
collection device around the gums, tongue and inside the cheek, until the sample presence indicator starts to turn blue.
1.2.6 The collection device is then inserted into the test cartridge.
1.2.7
During the testing process, the oral fluid is combined with a buffer solution, mixed and then incubated before being applied to the immunoassay test strips
housed within the cartridge.
1.2.8 The oral fluid flows by capillary action along the test strips, carrying with it labelled anti-drug antibody which is released from pads on the strips and in the
sample reservoir.
1.2.9 At designated zones on the strips, drug protein conjugate has been applied in bands which are invisible to the human eye. In the absence of a drug in the
sample, the anti-drug antibody will bind to the drug protein conjugate to form a line. In the presence of a drug the formation of this complex will be diminished,
forming a weaker line.
1.2.10 The analyser 'reads' the line intensity on the test strips. The detected line intensity is compared with a predetermined threshold derived from equivalent
concentration curves, to report qualitative results.
1.2.11
Test results are displayed on the analyser screen and can be printed using the printer.
1.2.12 The test cartridge is then removed from the analyser and disposed of in accordance with local and national regulations.
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