RediTest Cassette Drugs of Abuse Test Device

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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

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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:

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

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The RediTest Cassette Drugs of Abuse Test Device is a Screening Device Only

Positive results are presumptive

RediTest Cassette Drugs of Abuse Test Devices

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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 ABBREVIATIONAmphetamine AMPCocaine COCMarijuana THCMethamphetamine M-AMPOpiates OPIPhencyclidine PCP

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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

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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

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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

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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

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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

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*

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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

Reading Results

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Reading Results

Do Not read results after 4 Hours

5 Minutes

• Read results in:

Test Area

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Reading Results

In the Test Area:

• Line NEGATIVE

• No line POSITIVE

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

• 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

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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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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

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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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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

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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

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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

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