Abbott SoToxa TOX417 Mode D'emploi page 2

S O T O X A™ T E S T K I T I N S T R U C T I O N S F O R U S E
I N S T R U C T I O N S F O R U S E
F O R F O R E N S I C U S E O N LY
Important: Please read these instructions for use in full before using the test kit. Operators should ensure that they are familiar
with the local guidance provided by the appropriate Canadian authorities on correct collection and test procedures prior to
commencing a test.
K I T C O N T E N T S
• 25 × SoToxa ™ Test Cartridge
• 25 × SoToxa ™ Oral Fluid Collection Device
• 1 × Instructions for Use
I N T E N D E D U S E
The SoToxa ™ Test Kit is intended for the collection and testing of oral fluid in conjunction with the SoToxa ™ Mobile Test System
for screening for the presence of drugs of abuse and/or their metabolites in oral fluid.
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).
The product is for forensic use only. It is not for home use or for use within a therapeutic, clinical or workplace setting.
P R I N C I P L E O F T H E T E S T
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.
To carry out a test, the SoToxa Test Cartridge is first inserted into the analyzer. Oral fluid is then collected using the SoToxa Oral
Fluid Collection Device. Once the sample indicator starts to turn blue, sufficient oral fluid for analysis has been collected. The
collection device is then inserted into the test cartridge.
The sample flows by capillary action along the test strip, carrying with it labelled anti-drug antibody. At designated zones on the
strip, 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. The run time for the test cartridge is indicated by the countdown timer displayed
on the analyzer screen.
A procedural control is included in the test cartridge which confirms sufficient sample volume, adequate membrane wicking and
correct procedural technique. The absence of a line in the control position will indicate the test results are invalid. This will be
detected by the analyzer and reported as an invalid test result or test error.
The analyzer interprets the line intensity on the test strips which is compared with a predetermined threshold derived from
concentration curves, to report qualitative results. Upon completion of the test, the results are displayed and can be printed if
required. The test cartridge can then be removed.
S T O R A G E A N D S TA B I L I T Y O F T E S T K I T
Store all contents at 5°C to 30°C. Do not freeze.
The test kits are stable until the expiration date indicated on the packaging. The test cartridge shelf life is also indicated within
the test cartridge barcode, which the analyzer will read on insertion. If the test cartridge is not within expiration date, the
analyzer will not proceed with the test and will notify the operator that the test cartridge is expired.
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