Oral Fluid Collection/Screening

Training for Parents

Summary

• The utility of saliva as a biological specimen for the detection of recent drug use has been supported by a number of studies. Correlation of drug in

saliva and blood

has been reported.

• Unlike urine drug tests, saliva drug testing detects active drugs present at

low concentrations

(recent drug use, typically within hours).

Introduction

• New On•Site And, its ® OraLab

parent THC is lower

® 4 detects "under the influence" drug use for four drugs — even before they're metabolized.

detection level for

and the

most accurate

in the industry. • With

tests less than half the steps required by other oral fluid

, OraLab's no mess design is truly simple and easy to administer.

Introduction

• Its testing process is

100% observable

and eliminates the need for special facilities, which makes specimen tampering less likely.

• A

unique, patent-pending expresser

and single tube design allows you to

collect and store sufficient saliva

(can be measured and observed in the tube) for both immediate and confirmation testing.

Product Features

Seal and ship a presumptive positive result for confirmation, right in OraLab’s tamper-evident container.

Three simple steps – Collect, Test, and Store. Can be administered in 10-15 minutes.

Patented feature on test card enhances readability.

Collector absorbs sufficient saliva for both immediate and confirmation testing.

Expresser has locking device, so when the collector is removed it is drip-free.

Simultaneously tests for opiates, cocaine, methamphetamine, and THC (marijuana).

Intended Use

• On-Site OraLab

in saliva

specimens.

® 4

detects drugs of abuse

and provides for the collection, screening, transport, and storage of saliva • OraLab ® 4 is intended for forensic use in simultaneous,

qualitative

detection of multiple drugs and metabolites in saliva.

Intended Use

• OraLab ® 4 provides only

preliminary

analytical test results.

It is NOT an evidentiary test.

• An alternate, more specific chemical method must be used to obtain confirmed analytical results -

GC/MS testing via the Council’s contracted outside laboratory

.

OraLab Cutoff Concentrations

Drug

• COC (Cocaine) • OPI (Opiate) • MET (d-Methamphetamine) • THC (Delta 9 - Tetrahydrocannabinol)

ng/mL

20 40 50 50

Storage & Stability

• Store OraLab ® 4 tests at room temperature,

59 – 86 °F

, in the original foil pouch.

• If the foil pouch containing the OraLab profile card is

damaged

(e.g., a hole or tear), do NOT use that profile card.

® 4 • Do NOT use OraLab ®

than 1 year

4 profile card more

after the expiration date

on the foil pouch. (See attached Varian letter).

Specimen Collection & Handling

• Specimens containing human-sourced materials should be handled as if

potentially infectious

.

• Always wear

disposable gloves

and/or other appropriate personal protective equipment when collecting/handling any oral fluid specimens.

• On-Site OraLab

components testing kits

standard trash receptacle.

and

collection

may be disposed of in any

Subject Preparation

• Prior to collection, instruct the donor to

drink four ounces (4 oz.) of water

drink, etc.) for

10 minutes

.

, and to place nothing else in the mouth (food,

Subject Preparation

• Instruct the donor to

draw a pool of oral fluid into the mouth

action for a few moments before collection.

with a “puckering”

Instructions for Use

Step 1

• Have donor keep foam collector in the mouth until thoroughly soaked (

up to 3 minutes

).

The donor should not chew or suck on foam.

Instructions for Use

Step 2

• The

administrator

should place the collector foam-first into the expresser in the tube.

Instructions for Use

Step 3

• Slowly

push

the collector down

into the expresser

.

• You will feel some resistance about 2/3 the way down;

push past this

to reach the bottom of the expresser (you will hear a

popping sound).

Instructions for Use

Step 3

• The oral fluid will flow into the tube. To express the

maximum amount of sample

, lift up slightly and push downward a second time.

Note: It is important that a minimum of 1 ml of sample is collected.

Instructions for Use

Step 4

• Lift the collector out of the tube at a

straight upward angle

. • The

expresser

with it. will be removed • Throw

both

pieces away.

Instructions for Use

Step 5

• Open the

foil pouch

remove testing card. and

Note: Do not place profile card in mouth.

Instructions for Use

Step 6

• Place testing card in tube as shown,

“arrow” down

. • Allow testing card to drop to the

bottom

of the tube. • Wait

10 minutes

results.

and interpret

Note: Do not read results after 15 minutes.

Interpret Test Validity

• A

valid test

is indicated by a band in the area of the card next to

“TV” .

TV = Test Valid A = Amphetamine O = Opiate C = Cocaine P = Phencyclidine (PCP) M = Methamphetamine T = THC (Marijuana)

Profile card shown is for OralLab 6 product.

Interpret Test Validity

• Since a valid test may give a faint or incomplete band,

any Test Valid band

confirms that the test is valid.

• Due to the high viscosity and variability of some saliva samples, test results

may require up to 15 minutes

to form.

Profile card shown is for OralLab 6 product.

Interpret Test Validity

• An invalid test is indicated by the

absence of a distinct band

in the Test Valid area or by a

reddish reagent background

on the strip which obscures the presence of bands 15 minutes after the test is initiated.

Interpret Test Results

• Immediately interpret test results as either

negative

or

preliminary positive

.

Interpret Test Results

Negative Result

• A

negative result

drug (i.e., drug absent or below the cutoff) is the band in the area adjacent to the drug name.

for a given

PRESENCE

of a • The test result pictured here is

negative

for cocaine, opiate, amphetamine, PCP, methamphetamine, and THC (marijuana).

Interpret Test Results

• The

intensity

area may vary.

of the bands in the Results • A

negative

sample may give a

faint or incomplete band

.

• ANY band in the Result area indicates a

negative

result.

Interpret Test Results

Positive Result

• A

preliminary positive result

for a given drug (i.e., drug present

above the cutoff, suggesting current

or recent drug use) is the

ABSENCE

of a band in the test result area adjacent to the drug name. The adjacent area appears off-white.

• The result shown here is

preliminarily positive

for Cocaine.

Interpret Test Results

• If all drug results are

negative

, or if

no confirmation tests are required

, properly discard the test card and tube.

• When confirmation of a preliminary positive screen result is required, contact the Council on Alcohol and Drugs at (404) 223-2486 for instructions on how to obtain confirmation.

Confirmation Testing

Step 7

• To send for confirmation, tightly

seal

the tube with the cap.

• Contact the Council on Alcohol and Drugs for shipping instructions.

• Ship box according to local, state, or federal regulations as instructed.

Collection/Testing Problem

• If test did not run, or if invalid test results are obtained, contact the Council on Alcohol and Drugs at (404) 223-2486 after discarding the invalid test.

Technical Assistance

• Technical assistance can be obtained by contacting

Varian Technical Support

at

1 800-737-9667

.