Upload
jo-woolery
View
2.054
Download
0
Embed Size (px)
DESCRIPTION
6-Panel Drug Testing. On the spot results!
Citation preview
RediTest Cassette Drugs of Abuse Test Device
99 000 0189 REV 2 2
Package Insert
It is important to read the package insert before using
the device
It is important to read the package insert before using
the device
The information in this presentation is a The information in this presentation is a general overview on using the Redwood general overview on using the Redwood
Biotech RediTest Cassette Drugs of Abuse Biotech RediTest Cassette Drugs of Abuse Test DeviceTest Device
99 000 0189 REV 2 3
Training Objectives
RediTest Cassette Drugs of Abuse Test Devices
Collection Procedure Testing Procedure Reading Results Sending Presumptive Positive Results
in for Confirmation
99 000 0189 REV 2 4
RediTest Cassette Drugs of Abuse Test Devices
FDA - 510(k) “cleared to market” and is ideal for pre-employment, corrections, clinical and hospital use.
For professional in vitro diagnostic use only
CLIA Waived
99 000 0189 REV 2 5
CLIA Waived Devices
ANY agency performing medical testing using a “waived” device, must have either a:
CLIA License, or CLIA Certificate of Waiver.
The FDA does not regulate drugs of abuse testing in:
therefore CLIA requirements do not apply.
Forensic Probation
Parole Work Environments
For further information on the CLIA program visit:
http://www.fda.gov/cdrh/clia
99 000 0189 REV 2 6
The RediTest Cassette Drugs of Abuse Test Device is a Screening Device Only
Positive results are presumptive
RediTest Cassette Drugs of Abuse Test Devices
99 000 0189 REV 2 7
RediTest Cassette Drugs of Abuse Test Devices
Additional testing is necessary to confirm presumptive positive results
Positive results should be “confirmed” by an alternate method such as GC/MS (Gas Chromatography/Mass Spectrometry)
Professional judgment should be applied to any drug of abuse test result, particularly with preliminary positive results
99 000 0189 REV 2 8
Drugs of Abuse
RediTest Cassette Drugs of Abuse Test Device tests for the presence of the following drugs of abuse:
DRUG ABBREVIATIONAmphetamine AMPCocaine COCMarijuana THCMethamphetamine M-AMPOpiates OPIPhencyclidine PCP
99 000 0189 REV 2 9
Cut-off Levels
Amphetamine AMP 1,000 ng/mL *Cocaine COC 300 ng/mL *Marijuana THC 50 ng/mL *Methamphetamine M-AMP 1,000 ng/mLOpiates OPI 2,000 ng/mL *Phencyclidine PCP 25 ng/mL *
* - Meets SAMHSA cut-off levels
99 000 0189 REV 2 10
Device Packaging
The front of the foil pouch is labeled with:• Instructions• Result Interpretation Key
Example of the Front of the Foil Pouch
Instructions
Result Interpretation
Key
99 000 0189 REV 2 11
Lot Number & Expiration Date
Expiration DateLot Number
Lot Number and Expiration Date are located on the back of the foil pouch:
Example of the Back of the Foil Pouch
99 000 0189 REV 2 12
Drug Abbreviations
A list of the drug abbreviations are located on the back of the foil pouch:
Example of the Back of the Foil Pouch
Drug Abbreviations
Collection Procedure
99 000 0189 REV 2 14
Collection Procedure
• Collect urine specimen in a collection container
• Fill the cup to at least 1/3 full
• This helps ensure proper specimen volume for initial test and possible confirmation tests
Testing Procedure
16
Package Components
* Note: The desiccant pouch enclosed with the RediTest Cassette is part of the packaging, it is not a part of the test device.
• Open the foil pouch and remove the Test Device
Test DeviceTest Device
PipettePipette
Desiccant Pouch*Desiccant Pouch*
99 000 0189 REV 2 17
Testing Procedure
• Place cassette on a flat surface
• Holding the pipette vertically, transfer 3 drops of urine into each sample well
Sample Wells
Reading Results
99 000 0189 REV 2 19
Reading Results
Do Not read results after 4 Hours
5 Minutes
• Read results in:
Test Area
99 000 0189 REV 2 20
Reading Results
In the Test Area:
• Line NEGATIVE
• No line POSITIVE
Presumptive Positive for Cocaine
And Methamphetamine
99 000 0189 REV 2 21
Reading Results
• Any visible line, even a faint line, indicates a negative result
Negative
Negative
99 000 0189 REV 2 22
Invalid Results
• If an “invalid” result is obtained repeat the test using a new test device
• If the problem persists, contact Redwood Biotech Customer Support at (877) 444-0049
A result is “Invalid” when: The The “C”“C” (Control line) (Control line) does not developdoes not develop
Send Presumptive Positive Results to:
Redwood Toxicologyfor Confirmation
99 000 0189 REV 2 24
Filling Out Forms and Labels
Important Note: Please do not use red ink, felt tip pens or pencils on the specimen label or forms.
Blue and black ballpoint pens are preferred
Other types of ink may smear and make the information illegible
99 000 0189 REV 2 25
Preparing the Specimen for Confirmation Testing
• In front of donor, place the security seal over the top of the collection container
• Instruct the donor to initial and date the security seal
DL 09/20/05
99 000 0189 REV 2 26
BAR & THC
09/19/05
Jane Doe
123456 Agency Name
Donor ID
Preparing the Specimen for Confirmation Testing
• Fill out the Specimen ID/Chain of Custody label and indicate the positive drug(s) on the line marked “GC/MS Confirm: ____”
• Place the label on the collection container
99 000 0189 REV 2 27
Preparing the Specimen for Confirmation Testing
• Place the specimen in the plastic bag with the absorbent material; seal the bag
• Store in a secure area until the specimen is ready to be shipped to the laboratory
Absorbent Material
99 000 0189 REV 2 28
The number of specimens you are sending determines the shipping method:
When shipping five or more specimens use:
5 +
When shipping fewer than five specimens use:
<5Less than
Returning the Specimen For Confirmation
29
When shipping 5 or more specimens via DHL, contact DHL to schedule a pickup:
Call DHL for pick up:
(800) 247-2676Follow DHL prompts
- OR -Visit the DHL website to schedule a pickup:
http://www.dhl-usa.com/home/home.asp
5 +
Sending Specimens To The LabSending Specimens To The Lab
IMPORTANT: If you ship less than 5 specimens in a DHL Lab Pack, your agency may be billed $7.00IMPORTANT: If you ship less than 5 specimens in a DHL Lab Pack, your agency may be billed $7.00
99 000 0189 REV 2 30
When shipping fewer than five specimens:- Send via US Postal Service (Business Reply Mail)
box provided
<5Less than
Sending Specimens To The LabSending Specimens To The Lab
Summary
99 000 0189 REV 2 32
Summary
• The RediTest Cassette Drugs of Abuse Test Device provides only a preliminary result. A quantitative analytical method (i.e. GC/MS) is needed to obtain a confirmed result
• All positive results are presumptive
• For further details see the product insert
99 000 0189 REV 2 33
Contact Information
Phone: (877) 444-0049 or (707) 571-1157
Fax: (707) 577-8102
Website: www.redwoodbiotech.com
Redwood Biotech
Redwood Toxicology Laboratory
Phone: (800) 255-2159 or (707) 577-7959
Fax: (707) 577-0365
Website: www.redwoodtoxicology.com