For Forensic Use Only
NAME AND INTENDED USE
The Intercept® i2he™ Oral Fluid Collection Device is intended for use in the collection,
preservation and transport of oral specimens from the collection area to the laboratory. Oral
specimens collected with the Intercept® i2he™ Oral Fluid Collection Device may be tested for
Drugs of Abuse using the Intercept® i2he™ Oral Fluid Immunoassays.
This device is intended for use by trained professionals only and is not intended for home use.
PRINCIPLE OF The Intercept® i2he™ ORAL FLUID COLLECTION DEVICE
Saliva, also referred to as oral fluid, is a complex mixture of parotid, submandibular, sublingual
and minor salivary gland secretions mixed with mucin, bacteria, leukocytes, sloughed epithelial
cells, gingival crevicular fluid, and mucosal transudate. Mucosal transudate is the fluid derived
from the passive transport of serum components through the oral mucosa into the mouth.
The Intercept® i2he™ Oral Fluid Collection Device consists of a treated, absorbent cotton fiber
pad affixed to a plastic shaft (Oral Fluid Collection Pad) and a Preservative solution in a plastic
container (Oral Specimen Collection Vial). The Oral Fluid Collection Pad contains a small
amount of common salts creating a hypertonic environment in the mouth around the area of
collection. The Pad is placed under the tongue until a blue color appears in the sample
adequacy window, or the collection time reaches 15 minutes.
Following collection of the oral specimen, the Oral Fluid Collection Pad is removed from the
mouth and is placed into the Oral Specimen Collection Vial. The Oral Specimen Collection
Vial contains a Preservative solution that inhibits the growth of oral microorganisms recovered
on the Oral Fluid Collection Pad. The vial is sealed with a plastic cap and transported to a
laboratory for processing and testing.
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WARNINGS AND PRECAUTIONS
Oral Specimen Collection Vials are breakable and should be handled with care.
Oral fluid is not considered potentially infectious unless it contains blood. “Updated U.S.
Public Health Service Guidelines for Management of Occupational Exposures to HCV, HCV,
HIV and Recommendations for Postexposures Prophylaxis.” (CDC, MMWR, 2001). Use
of gloves for oral fluid testing is optional. Test administrators with breaks in the skin
(cuts, abrasions, or dermatitis) should wear gloves when performing oral fluid testing.
Wash hands thoroughly after performing each oral fluid test and after contact with
oral fluid.
Occupational Safety and Health Administration (OSHA) regulations apply to personnel
collecting and handling specimens.
Federal, state and local regulations for human biologic test specimens apply to the
transportation of oral fluid specimens which may contain etiologic agents.
Use freshly prepared 10% bleach to decontaminate surfaces in the event of a spill of a
collected specimen.
Avoid contamination of the Oral Fluid Collection Pad and Preservative solution with
foreign matter.
Do not use the Oral Fluid Collection Pad if the package has been previously opened.
Do not touch the Oral Fluid Collection Pad with fingers before or after specimen
collection.
Do not use if the Oral Fluid Collection Pad is wet.
Do not use device beyond expiration date shown on the device package.
Do not use if the Oral Specimen Collection Vial is empty or has been damaged.
Do not use the collector if prior to sample collection the blue indicator dye is visible in
the sample adequacy window.
For additional information on biosafety, refer to “Universal Precautions for Prevention
of Transmission of Human Immunodeficiency Virus, Hepatitis B Virus, and other
Blood-borne Pathogens in Health-Care Settings.” (CDC, MMWR, June 24, 1998).
MATERIALS PROVIDED WITH EACH DEVICE
1.
One treated, cotton fiber Oral Fluid Collection Pad on a plastic shaft with sample
adequacy window.
2.
One Oral Specimen Collection Vial containing Preservative solution.
MATERIALS REQUIRED BUT NOT PROVIDED
•
Timer capable of timing fifteen (15) minutes.
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30˚C
2˚C
(36-86˚F)
STORAGE OF UNUSED INTERCEPT® i2he™ ORAL FLUID
COLLECTION DEVICE
Store unused Intercept® i2he™ Oral Fluid Collection Devices at 2°-30°C/
36°-86°F. Exposure to higher temperatures (>37°C/98°F) should be avoided.
DIRECTIONS FOR USE
Wait at least ten (10) minutes after ingesting any food,
drink, or drugs before collecting a sample.
1.
Open the side of the foil pouch containing the Oral
Fluid Collection Pad. (fig. 1)
fig. 1
2.
Use the plastic shaft of the device to pull the Pad
out of the packaging sleeve. Do not touch the Pad.
(fig. 2)
fig. 2
3.
4.
Place the Pad inside the
mouth under the tongue,
with the white side of the
stick facing upward.
Instruct the donor to avoid
biting down on the plastic
shaft. (fig. 3a & 3b)
fig. 3a
Begin timing the collection process. Keep the Pad
under the tongue until the indicator turns blue.
Average collection times are 3-4 minutes. Should
the collection time reach 15 minutes, stop the
collection and proceed to step 5. (fig. 4)
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fig. 3b
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fig. 4
5.
Remove the Oral Specimen Collection Vial from
the other side of the foil package. Record donor
identification information and date of collection
on the vial label in the space above the lot
number, unless another documentation method
will be used. (fig. 5)
fig. 5
6.
Hold the Oral Specimen Collection Vial in an
upright position and unscrew the cap to open the
vial. Do not spill or otherwise remove the fluid
from the vial. (fig. 6)
7.
After the collection is complete, remove the Oral
Fluid Collection Pad from the mouth, insert into
the Oral Specimen Collection Vial and slowly
push downward until reaching the bottom of the
vial (Pad will be submersed in the Preservative
solution). (fig. 7)
8.
Screw the cap onto the Oral Specimen Collection
Vial. (fig. 8)
9.
Follow the directions provided on the applicable
custody and control form to prepare and mail the
sample to a laboratory for testing.
fig. 6
fig. 7
fig. 8
STORAGE AND TRANSPORTATION OF ORAL SPECIMENS
1.
Collected specimens must be stored and transported in the Oral Specimen Collection
Vial containing the Preservative solution.
2.
Collected specimens may be transported to the laboratory at ambient temperature
via ground or overnight courier. Specimens should be protected from impact and
temperatures outside the range of 4-37°C/39-98°F.
3.
Specimens can be stored a maximum of 21 days from the time of collection until analysis
at the laboratory. Storage at -20°C/-4°F is recommended for greater than 21 days storage.
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PERFORMANCE CHARACTERISTICS
The Intercept® i2he™ Oral Fluid Immunoassays can accurately and reliably detect drugs of
abuse in samples collected with the Intercept® i2he™ Oral Fluid Collection Device. Studies
have shown agreement between assay results and confirmation testing by liquid
chromatography/mass spectrometry (LC/MS or LC/MS/MS). (Refer to the individual assay
package inserts for specific performance data.)
Intercept® i2he™ Oral Fluid Collection Device collects 1mL of saliva in under 15 minutes.
Stability of the drugs collected are maintained until processing at the laboratory.
KIT CONFIGURATIONS
Components
Each Intercept® i2he™ Package
Containing:
OraSure 1001-0364
50 Count
OraSure 1001-0365
500 Count
Oral Specimen Collection Vial (1)
50
500
Oral Fluid
Collection Pad (1)
50
500
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EXPLANATION OF SYMBOLS
Batch Code
Do Not Reuse
Catalog Number
Forensic Use Only
Caution, Consult
Accompanying Documents
Manufacturer
Consult Instructions for Use
Manufactured For
Collection Device
Temperature Limitation
Collection Pad
Use By
Contents
Volume
Intercept i2he Diluent
Oral Specimen Vial
Tear Here
Package Insert
Part Number
7
220 East First Street
Bethlehem, PA 18015
Made in USA
For additional assistance,
call OTI Technical Service:
In the USA 1-800-673-7873
Outside the USA (001) 610-882-1820
PN 3001-2607 rev. 05/14
www.OraSure.com • www.Intercept2.com
© 2014 OraSure Technologies, Inc. Intercept® is a registered trademark of OraSure Technologies, Inc.
Intercept® i2heTM is a trademark of OraSure Technologies, Inc.
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