Introduction - Abbott SoToxa TOX400P User Manual

1 . I N T R O D U C T I O N
For forensic use only.
The SoToxa™ Mobile Analyzer 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 forensic use only.
This assay is for the analysis of oral fluid samples only. Testing of inappropriate samples will not give valid results. A positive result indicates presence of the
drug or its metabolites but does not indicate level of intoxication, administration route or concentration in the oral fluid. A negative result may not necessarily
indicate drug-free oral fluid. Negative results can be obtained when a drug is present but below the cutoff level of the test.
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 analyzer.
TOX400P | TOX400PFUO | TOX400SFUO
1.

Introduction

1.1 Intended use
The SoToxa™ Mobile Analyzer 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. The product is for forensic use only. It is not for home use or for use within a therapeutic, clinical
or workplace setting.
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 Analyzer, and the SoToxa™ Test Kits which contain the SoToxa™ Test
Cartridge and the SoToxa™ Oral Fluid Collection Device.
1.2.2 The analyzer 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 analyzer and is warmed by the analyzer 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 antibodies 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 antibodies 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
On receipt of the analyzer by the user, the analyzer is already configured by the manufacturer to read specific cartridge types. Additional
cartridge types can be added by the user by application of cartridge updates (see section 8.4 Installed cartridges and updating cartridge types).
1.2.11 The analyzer '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.
1.2.12
Test results are displayed on the analyzer screen and can be printed using the printer.
1.2.13
The test cartridge is then removed from the analyzer and disposed of in accordance with local and Federal regulations.
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