Alere DDS 2 - 1 Introduction; Intended Use; Test Principle

APOC0274 Ed.3a
Page 1 of 35
+44 (0)1235 861 483 | aleretoxicology.co.uk
Alere™ DDS
®
2 Mobile Analyser User Guide | 1. Introduction
The Alere™ DDS
®
2 Mobile Analyser is intended to be used in conjunction with the Alere™ DDS
®
2 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 GCMS (gas chromatography-
mass spectrometry) or LCMS (liquid chromatography-mass spectrometry).
Please read this user guide and the test kit instructions for use carefully, prior to using the analyser.
DDS2-400-P | DDS2-400-S-UK | DDS2-400-S-AUS | DDS2-400-S-US | DDS2-400-S-EU
1.1 Intended use
The Alere DDS2 Mobile Analyser is intended to be used in conjunction with the Alere DDS2 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 GCMS (gas chromatography –
mass spectrometry) or LCMS (liquid chromatography – mass spectrometry).
1.2 Test principle
1.2.1 The Alere DDS2 Mobile Test System consists of the analyser, and the Alere DDS2 Test Kits which contain the
Alere DDS2 Test Cartridge and the Alere DDS2 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 test 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 test 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 On receipt of the analyser by the user, the analyser is already configured by the manufacturer to read specific
test cartridge types. Additional test cartridge types can be added by the user by application of test cartridge
updates (see section 11.2 Updating Alere DDS2 Mobile Analyser types).
1.2.11 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.
1.2.12 Test results are displayed on the analyser screen and can be printed using the printer.
1.2.13 The test cartridge is then removed from the analyser and disposed of in accordance with local and
national regulations.
1 Introduction