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T R A I N I N G G U I D E

InstaCube Oral Fluid Drug TestFor Forensic Use Only

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3Contents

The information in this presentation is a general overview on performing and interpreting the InstaCube Oral Fluid Drug Test screening device.

Product Training Contents:

• Technical information

• Product overview

• Performing a saliva drug screen

• Result interpretation

• Additional support services

DrugTestsInBulk.com | 866.465.2855

4Technical Information

For complete instructions, limitations and warnings, please refer to the Package Insert (Instructions for Use) before using this screening device.

These tests provide visual qualitative results and are intended for in vitro diagnostic use only. The InstaCube Oral Fluid Drug Test is available in single drug analyte format. It is intended for Forensic Use Only.

Saliva drug screen assays provide only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-tandem mass spectrometry (LC-MS/MS) are the preferred confirmatory methods.


Product Overview

6Overview

This training may be used with InstaCube Oral Fluid Drug Test (Forensic Use Only).

• For Forensic Use Only

• Saliva test targets up to 12 illicit and prescription drugs

• Simple procedure: collect, insert, and read results

• Convenient and non-invasive rapid onsite screening

• Eliminates need for cross gender observation

• Reduces sample adulteration or contamination


7Abbreviations and Cutoff Level Concentrations

Test Calibrator Cut-off (ng/mL)

Amphetamine (AMP) D-Amphetamine 50

Cocaine (COC) Benzoylecgonine 20

Marijuana (THC) 11-nor-Δ9-THC-9 COOH 12

Methamphetamine (MET, mAMP) D-Methamphetamine 50

Opiate (OPI) Morphine 40

Methadone (MTD) Methadone 30

Test Calibrator Cut-off (ng/mL)

Phencyclidine (PCP) Phencyclidine 10

Oxycodone (OXY) Oxycodone 20

Benzodiazepines (BZO) Oxazepam 10

Buprenorphine (BUP) Buprenorphine 5

Barbiturates (BAR) Secobarbital 50

Alcohol (ALC) Alcohol >0.02% B.A.C

The cut-off level is the specified concentration at which a drug/metabolite can be detected in a sample. Above that

concentration, the test is called a presumptive positive, and below that concentration, it is called negative.


8Marijuana In Oral Fluid (Saliva)

Marijuana is an exception and different from other drugs in how its

use is captured in an oral fluid test.

The following apply to oral fluid testing for Marijuana:

• The oral fluid test only picks up residue of Marijuana trapped in the mouth from

recent use because the metabolite or parent drug concentrations in Marijuana do

not cross into oral fluid 25 collectors

• Presumptive positive test results for Marijuana in oral fluid reflect very recent

usage within the last 3 hours to 1 day

• Drug test results for Marijuana can be different between an oral fluid test and a

urine test because the oral fluid test only detects recent Marijuana usage from

residue and a urine test is based on a metabolite which takes at least 4 hours,

often longer, to get processed though the body’s internal organs into the urine


9Precautions, Storage and Stability

Precautions:

• For in vitro diagnostic use

• For forensic use only

• The test is for one time use only

• Do not use after the expiration date

• The test device should remain in the sealed pouch until use

• The used test device should be discarded according to

federal, state and local regulations

• Do not use this test if you are color-blind

• Safety data sheets available for professional user upon

request

Device storage and stability:

• Store packaged in the sealed pouch at 59-86°F (15-30°C)

• The tests are stable through the expiration date printed on

the pouch

Instacube

THC50/COC300/AMP1000/MAMP1000/BAR300/BZO300/MOP/PCP25/MTD300/OXY100

Lot: D1612081 Exp: 2020-11

Product title

Lists available tests

Lot #

Expiration date

EXAMPLE INFORMATION


Performing a Saliva Drug Screen

11Performing a Saliva Drug Screen

Specimen storage and preparation:

• The oral specimen should be collected using the collector

provided with the kit. No other collection devices should be used

with this test

• Oral fluid collected at any time of day may be used

• For best results, test specimens immediately following collection

• Please refer to package insert if specimen cannot be tested

immediately



Gather all necessary testing supplies:

Materials provided

• 1 step-by-step test instruction (package insert)

• 25 collectors

• 25 test devices

• Security seals

• Alcohol color chart (if applicable)

Recommended but not provided

• Timing device (timer, clock, watch, etc.)

• Disposable gloves



InstaCube Oral Fluid Drug Test foil pouch (example):

The foil pouch contains the following information: list of drugs screened, part number, lot #, and expiration date.

• Make sure test device is at room temperature before opening

• Test device must remain in sealed pouch until use

• Do not use beyond the expiration date



Specimen collection procedure:

Instruct donor on proper procedure for saliva collection.

Warnings and precautionsPrior to testing, DO NOT place anything in the mouth for at least 10 minutes.

This includes:• Food• Gum• Drink• Tobacco products• Any other substance or material



Specimen collection procedure (cont.):

Have donor select the device

• Donor should give the sealed test to the collector to record lot #

and expiration date

• Collector records lot # and expiration date information, then

returns device to donor

Note: Collector should not handle the test device again until specimen is collected and the collector is ready to begin testing.

EXAMPLE INFORMATION




1. Remove the test device from the sealed pouch and use it as soon as possible2. Remove the collector from the sealed pouch, insert the sponge into mouth. Close mouth and continuously move the sponge around for oral fluid collection. Soak sponge in oral fluid and swab the inside of the mouth and tongue

• Collect oral fluid for at least 7 minutes or until sponge is soft and fully saturated• No hard spots should be felt on sponge when saturated• DO NOT suck, bite, or chew on sponge as proper collection may not occur




Donor returns collected specimen back to collector

1. Place the test device on a clean and flat surface2. Remove the collection sponge from the mouth and insert the sponge into the screening device, press until the collector cap is sealed with the device tightly

• Keep upright on a flat surface when inserting and pressing the sponge3. Peel off label and wait for the colored signal to appear in the test results area

• If there is no flow within 1 minute after completing step 2 (above) please refer to the troubleshooting guide in additional support services section


Result Interpretation

19Interpreting Test Results

Reading the results:

• Keep upright and on a flat surface while test is running

• Peel off the label to view results

• If your product has Alcohol (ALC) read ONLY alcohol

results at 3 minutes

• Read all other results at 10 minutes

Note: For detailed operation instructions, please refer to the package insert or procedure card.


20Interpreting Alcohol Test

Reading alcohol test results:“If applicable”

• Read at 3 minutes

• Negative Result: • The alcohol pad shows no color change (remains white or cream colored); it should be

interpreted as a negative result (no alcohol present)

• Invalid Result:• The outer edges of the alcohol pad produces a slight color but the majority of the pad

remains colorless should be repeated to ensure complete saturation of the alcohol pad with oral fluid

• If the second result is the same, the result should be interpreted as being negative (no alcohol present)

• Positive Result:• The alcohol tests produces a color change to green to blue in the presence of salivary

alcohol 0.02% B.A.C. or higher. At higher alcohol concentration near 0.30% B.A.C the color may change to a dark blue-gray


21Interpreting Drug Test Results

Reading drug test results:

• Read the drug test results at 10 minutes

• Each test strip within the device includes an internal procedural

control (C) that ensures proper device function

• Control lines should form on all control (C) lines, indicating proper

functioning of the test device


22Negative Example

Negative test result:

• A colored line appears in the Control region (C) and a colored line appears in the

Test region (T) next to each drug name

• Negative results means the drug concentrations in the saliva sample are below the

designated cutoff levels for a particular drug tested

Note: Any indication of a colored line, regardless of color intensity, is considered a negative test result.

CONTROL LINE

TEST LINE


23Presumptive Positive Example

Presumptive positive test result:

• A colored line appears in the Control region (C) and NO line appears in the Test

region (T) next to the name

• The presumptive positive result means the drug concentrations in the saliva

sample is greater than the designated cutoff levels for a specific drug

The test device provides only qualitative, preliminary analytical results. Gas chromatography-mass spectrometry (GC-MS) or liquidchromatography-tandem mass spectrometry (LC-MS/MS) are preferred confirmatory methods.

CONTROL LINE

TEST LINE


24Invalid Example

Invalid test result:

• No line appears in the Control region (C)

• Insufficient specimen volume or incorrect procedural techniques are the most

likely reasons for control line failure

• Read the directions again and repeat the test with a new test device

• If the result is still invalid, contact customer support

CONTROL LINE

TEST LINE


25Interpretation of Results

NEGATIVEThe control line must be colored to indicate the test is valid. Any visible line, even a faint line, indicates a negative result.

PRESUMPTIVE POSITIVEThe control line must be colored to indicate the test is valid. The test area must be snow white to be considered positive. Additional testing is necessary to confirm the presumptive positive results. Positive results should be

confirmed” by an alternate method such as GC-MS or LC-MS/MS.

INVALIDWhen there is no line in the control line area, the result is invalid. If an invalid result is obtained repeat the test using a new test device.


Additional Support Services

27Test Limitations• Instant saliva (oral fluid) tests provide only a qualitative, preliminary analytical result. A secondary analytical method must be

used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method

• There is a possibility that technical or procedural errors, as well as other interfering substances in the saliva specimen may

cause erroneous results

• A positive result does not indicate level or intoxication, administration route or concentration in saliva

• A negative result may not necessarily indicate drug-free saliva. Negative results can be obtained when drug is present but

below the cut-off level of the test

• The test does not distinguish between drugs of abuse and certain medications

• A positive result might be obtained from certain foods or food supplements


28Troubleshooting Guide• Insufficient Saliva (collection device is not completely softened/saturated)CAUSE: Interfering substance, collection time, or dehydration • Confirm donor has not had any food, drink, gum, tobacco products or other substance in their mouth at least 10 minutes prior to collection — Ensures that “neat saliva” has been collected and that no substance interferes with collection or wicking process • Make sure donor collects oral fluid for at least 7 minutes or until sponge is soft and fully saturated — No hard spots should be felt on sponge when saturated • Allow donor to have a drink water and retest at least 10 minutes later — In rare instances a donor may be dehydrated and unable to produce sufficient saliva needed for collection

• No Flowing (saliva not wicking on test strips)CAUSE: Failure of saliva flow or wicking properly can be caused by insufficient sample volume, extremely viscous saliva, or an air bubble blocking the flow. • Confirm there is sufficient saliva (see above) and that the donor DID NOT suck, bite, or chew on the sponge during collection — Insufficient sample volume or improper collection may have occurred • Move device back and forth on a flat surface several times; keep vertical (Do not tilt during the whole process) — Saliva may be extremely viscous or an air bubble may be blocking the flow • Gently remove the collector cap and reseal tightly — Saliva may be extremely viscous or an air bubble may be blocking the flow


29Troubleshooting Guide (Cont.)• Flooding (collection device is over saturated) CAUSE: Excess saliva to the membrane causes the normal reaction to be circumvented. Test strips will be saturated but no lines form next to the control and or test lines

• Donor should stop collection once device is completely saturated• Collection device will become soft and “flimsy” indicating device is completely saturated

• Keep test upright (vertical) on a flat surface when inserting the sponge and while the test is running• Test was not placed vertically on a flat surface causing flooding on the test strips


CONGRATULATIONS!!!You have completed the training course

For additional information or assistance with this device contact Customer Support at 866.465.2855

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