Product Manual

iScreen
®
OFD Cotinine Test Device
Package Insert for the COT Test for Oral Fluids
A rapid, screening test for the simultaneous, qualitative detection of Cotinine in human oral fluid.
For healthcare professionals including professionals at point of care sites.
For in vitro diagnostic use only.
INTENDED USE
The Alere
iScreen
®
OFD Cotinine Test Device is a lateral flow chromatographic
immunoassay for the qualitative detection of cotinine in oral fluids at a cut-off
concentrations of 30 ng/mL.
This assay provides only a preliminary analytical test result. A more specific
alternate chemical method must be used in order to obtain a confirmed analytical
result. Gas chromatography/mass spectrometry (GC/MS), gas
chromatography/tandem mass spectrometry (GC/MS/MS) and liquid
chromatography/tandem mass spectrometry (LC/MS/MS) are the preferred
confirmatory methods. Professional judgment should be applied to any drug of
abuse test result, particularly when preliminary positive results are indicated.
SUMMARY
The Alere
iScreen
®
OFD Cotinine Test Device is a rapid, oral fluid screening test that
can be performed without the use of an instrument. The test utilizes antibodies to
selectively detect elevated levels of specific drugs in human oral fluid.
Cotinine (COT)
Cotinine is the first-stage metabolite of nicotine, a toxic alkaloid that stimulates the
autonomic ganglia and central nervous system in humans. Nicotine is a drug to which
virtually every member of a tobacco-smoking society is exposed whether through direct
contact or second-hand inhalation. Aside from tobacco, nicotine is also commercially
available as the active ingredient in smoking replacement therapies such as nicotine
gum, transdermal patches and nasal sprays.
Although nicotine is excreted in saliva, the relatively short half-life of the drug makes it
an unreliable marker for tobacco use. Cotinine, however, demonstrates a substantially
longer half-life than nicotine, bears a high correlation with plasma cotinine levels and
has been found to be the best marker for smoking status compared with saliva nicotine
measurements, breath carbon monoxide testing and plasma thiocyanate testing
1
. The
window of detection for cotinine in saliva at a cutoff level of 30 ng/mL is expected to be
up to 1-2 days after nicotine use.
ASSAY PRINCIPLE
The Alere
iScreen
®
OFD Cotinine Test Device is an immunoassay based on the
principle of competitive binding. Drugs that may be present in the oral fluid specimen
compete against their respective drug conjugates for binding sites on their specific
antibody.
During testing, a portion of the oral fluid specimen migrates upward by capillary action.
A drug, if present in the oral fluid specimen below its cut-off concentration, will not
saturate the binding sites of its specific antibody. The antibody will then react with the
drug-protein conjugate and a visible colored line will show up in the test line region of
the specific drug strip. The presence of drug above the cut-off concentration in the oral
fluid specimen will saturate all the binding sites of the antibody. Therefore, the colored
line will not form in the test line region.
A drug-positive oral fluid specimen will not generate a colored line in the specific test
line region of the strip because of drug competition, while a drug-negative oral fluid
specimen will generate a line in the test line region because of the absence of drug
competition.
To serve as a procedural control, a colored line will always appear at the control line
region, indicating that proper volume of specimen has been added and membrane
wicking has occurred.
REAGENTS
The test contains membrane strips coated with drug-protein conjugates on the test line,
polyclonal antibody against gold-protein conjugate at the control line, and a dye pad
which contains colloidal gold particles coated with antibody specific to Cotinine.
PRECAUTIONS
• For healthcare professionals including professionals at point of care sites.
• The device is for in vitro diagnostic use only. Do not use after the expiration date.
• The oral fluid test device should remain in the sealed pouch until use.
• Saliva is not classified as biological hazard unless derived from a dental procedure.
• The used collector and device should be discarded according to federal, state and
local regulations.
STORAGE AND STABILITY
Store as packaged in the sealed pouch at 2-30°C. The test is stable through the
expiration date printed on the sealed pouch. The test devices must remain in the sealed
pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
SPECIMEN COLLECTION AND PREPARATION
The oral fluid specimen should be collected using the collector provided with the kit,
following the detailed instructions under Directions for Use. No other collection devices
should be used with this assay. Oral fluid collected at any time of the day may be used.
MATERIALS
Materials Provided
• Test devices
• Caps
• Sponge protectors
• Procedure cards
• Security seals
• Package insert
Materials Required but not Provided
• Timer
DIRECTIONS FOR USE
Allow the Alere
iScreen
®
OFD Cotinine Test Device to come to room temperature
[15-30°C (59-86ºF)] prior to testing. Instruct the donor not to place anything in the
mouth including food, drink, gum, or tobacco products for at least 10 minutes
prior to collection.
1. Bring the pouch to room temperature before opening it. Remove the test and Cap
from the sealed pouch and use the test as soon as possible.
2. Remove the Sample Collector Protector from the collection Sponge. Instruct the
donor to insert the Sponge end of the collector into the mouth and actively swab the
inside of the mouth and the top of the tongue. As soon as the Sponge softens
slightly, the donor should gently press the Sponge between the tongue and teeth to
ensure complete saturation.
3. The Sponge is saturated when no hard spots can be felt. Collect for a total of at least
three (3) minutes before removing the Sponge. Remove the collector from the mouth.
4. Align the Red Arrow on the device with one of the White Marks on the Cap. Insert
the collector vertically into the Cap and press down firmly. Twist the Cap
clockwise 180° until the Red Arrow lines up with the other White Mark.
5. Place the test device horizontally on a clean and level surface with facing up.
6. Read results at 10 minutes. Do not read results after 1 hour.
7. If positive results are observed, secure Cap with security seal and send the device to
a laboratory for confirmation. The laboratory can access the reservoir through the
Sample Port.
8. For detailed operating instructions, please refer to the Procedure Card.
INTERPRETATION OF RESULTS
(Please refer to the previous illustration)
NEGATIVE:* All test lines appear. One colored line should be in the control region (C),
and other apparent colored line should be adjacent in the test region (Drug/T). This
negative result indicates that the drug concentration is below the detectable level or
drug free.
*NOTE: The shade of color in the test region (Drug/T) will vary, but it should be
considered negative whenever there is even a faint colored line.
POSITIVE: One colored line appears in the control region (C). Any test line not
appears in the test region (Drug/T). This positive result indicates that the drug
concentration is above the detectable level.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect
procedural techniques are the most likely reasons for control line failure. Review the
procedure and repeat the test using a new test panel. If the problem persists,
discontinue using the lot immediately and contact the manufacturer.