RediTest Cassette Drugs of Abuse Test Device

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RediTest Cassette Drugs of Abuse Test Device
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Package Insert
The information in this presentation is a general
overview on using the Redwood Biotech RediTest
Cassette Drugs of Abuse Test Device

• It is important to read the package insert before
  using the device

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Training Objectives

• RediTest Cassette Drugs of Abuse Test Devices
• Collection Procedure
• Testing Procedure
• Reading Results
• Sending Presumptive Positive Results in for
  Confirmation

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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

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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

Forensic Probation Parole Work Environments
therefore CLIA requirements do not apply.

• For further information on the CLIA program
  visit

http//www.fda.gov/cdrh/clia
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RediTest Cassette Drugs of Abuse Test Devices

• The RediTest Cassette Drugs of Abuse Test Device
  is a Screening Device Only
• Positive results are presumptive

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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

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Drugs of Abuse
RediTest Cassette Drugs of Abuse Test Device
tests for the presence of the following drugs of
abuse
DRUG ABBREVIATION Amphetamine AMP Cocaine COC Mari
juana THC Methamphetamine M-AMP Opiates OPI Phency
clidine PCP
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Cut-off Levels
Amphetamine AMP 1,000 ng/mL Cocaine COC 300 ng/m
L Marijuana THC 50 ng/mL Methamphetamine M-AMP
1,000 ng/mL Opiates OPI 2,000 ng/mL
Phencyclidine PCP 25 ng/mL
- Meets SAMHSA cut-off levels
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Device Packaging

• The front of the foil pouch is labeled with
• Instructions
• Result Interpretation Key

Result Interpretation Key
Instructions
Example of the Front of the Foil Pouch
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Lot Number Expiration Date
Lot Number and Expiration Date are located on the
back of the foil pouch
Expiration Date
Lot Number
Example of the Back of the Foil Pouch
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Drug Abbreviations
A list of the drug abbreviations are located on
the back of the foil pouch
Drug Abbreviations
Example of the Back of the Foil Pouch
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Collection Procedure
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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

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Testing Procedure
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Package Components

• Open the foil pouch and remove the Test Device

Pipette
Test Device
Desiccant Pouch
Note The desiccant pouch enclosed with the
RediTest Cassette is part of the packaging, it is
not a part of the test device.
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Testing Procedure

• Place cassette on a flat surface
• Holding the pipette vertically, transfer 3 drops
  of urine into each sample well

Sample Wells
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Reading Results
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Reading Results

• Read results in

Test Area
5 Minutes
Do Not read results after 4 Hours
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Reading Results
In the Test Area
Presumptive Positive for Cocaine And
Methamphetamine
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Reading Results

• Any visible line, even a faint line, indicates a
  negative result

Negative
Negative
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Invalid Results
A result is Invalid when
The C (Control line) does not develop

• If an invalid result is obtained repeat the
  test using a new test device
• If the problem persists, contact Redwood Biotech
  Customer Support at [phone]

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Send Presumptive Positive Results toRedwood
Toxicologyfor Confirmation
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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
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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
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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

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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
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Returning the Specimen For Confirmation
The number of specimens you are sending
determines the shipping method
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When shipping five or more specimens use
lt5
When shipping fewer than five specimens use
Less than
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Sending Specimens To The Lab
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When shipping 5 or more specimens via DHL,
contact DHL to schedule a pickup
Call DHL for pick up [phone] Follow DHL
prompts - OR - Visit the DHL website to schedule
a pickup http//www.dhl-usa.com/home/home.asp
IMPORTANT If you ship less than 5 specimens in a
DHL Lab Pack, your agency may be billed 7.00
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Sending Specimens To The Lab
lt5

• When shipping fewer than five specimens
• Send via US Postal Service (Business Reply Mail)
  box provided

Less than
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Summary
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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

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Contact Information
Redwood Biotech
Phone [phone] or [phone] Fax   (70
7) 577-8102 Website www.redwoodbiotech.com
Redwood Toxicology Laboratory
Phone [phone] or [phone] Fax (707)
577-0365 Website www.redwoodtoxicology.com