Tabla de contenido
Idiomas disponibles
Idiomas disponibles
A
1
2
3
B
5
6
C
8
9
11
12
C
Contents
4
IT
ES
PT
FR
7
NL
DA
NO
CS
10
RU
HR
VI
ID
®
®
®
®
®
®
®
®
®
®
®
®
®
®
®
®
®
®
2 Test Kit: Petunjuk Penggunaan
®
Alere DDS
2 Test Kit
®
Instructions for use
1
Important: Please read these instructions for use in full before using the test kit. The Alere DDS
Cartridge will not provide results for all of the drugs and or metabolites that are indicated in these
6
instructions. Please refer to the description on the packaging of the test cartridge
for the specific details of the drug panel in use.
11
Kit contents
25 x Alere DDS
®
2 Test Cartridge
16
25 x Alere DDS
®
2 Oral Fluid Collection Device
21
1 x Instructions For Use
26
Intended use
The Alere DDS
2 Test Kit is intended for the collection and testing of oral fluid as part of the Alere DDS
®
31
Test System for screening for the presence of drugs of abuse and/or their metabolites in oral fluid. For professional
in vitro use only.
36
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).
41
Principle of the test
46
The Alere DDS2 Mobile Test System consists of the Alere DDS2 Mobile Analyser and the Alere DDS2 Test Kit. The
51
test kit consists of the disposable Alere DDS2 Test Cartridge, containing test reagents, and the Alere DDS2 Oral
Fluid Collection Device.
56
To carry out a test, the Alere DDS2 Test Cartridge is first inserted into the analyser. Oral fluid is then collected using
the Alere DDS2 Oral Fluid Collection Device. Once the sample indicator starts to turn blue, sufficient oral fluid for
61
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
66
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
71
cartridge is indicated by the countdown timer displayed on the analyser screen.
76
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 analyser and reported as a test error.
81
The analyser interprets the line intensity on the test strips which is compared with a predetermined threshold
86
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.
91
Storage and stability of reagents
Store all contents at 15°C to 25°C. Do not freeze.
The reagents are stable until the expiry date indicated on the packaging. The test cartridge shelf life is also carried
in the test cartridge barcode, which the analyser will read on insertion. If the test cartridge is not within expiry date,
the analyser will not proceed with the test.
EN
2 Test
®
2 Mobile
®
1
- Enlaces rápidos:
- Alere Dds ® 2 Test Kit:...
Hide quick links:
Tabla de contenido
