PROFILE® II / IIA VERDICT® Screen 2 6632

User Manual: Screen 2

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PROFILE®-II / PROFILE®-IIA / VERDICT®-II
PRODUCT INSERT
The PROFILE®-II /PROFILE®-IIA /VERDICT®-II products are one-step qualitative screening assays for the detection of one or
more of the following: Cannabinoids (THC), Opiates, Amphetamine, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates,
Methadone, Benzodiazepines, Propoxyphene, Methamphetamine/ 3,4 Methylenedioxymethamphetamine and Oxycodone or their
metabolites in human urine. All PROFILE-II/PROFILE II-A/VERDICT-II product(s) are covered by this insert. Refer to
product labeling for the actual drugs assayed by the kit or system configuration.
The Lateral Flow (LatFlo®) Adulterant Strip (LFAS) is a one-step qualitative screening assay for the detection of Oxidants and
Nitrites and the Determination of Specific Gravity and pH Values in human urine. It is used to evaluate specimens for adulteration
prior to Drugs of Abuse urine (DAU) testing. The LFAS strip is only for Forensic/Toxicology use and not for in vitro diagnostic
applications. The LFAS test strip is only contained in products labeled PROFILE-IIA or VERDICT-II with “LFAS” on the
label.
1. INTENDED USE
The PROFILE-II/VERDICT-II Drugs of Abuse Test is a one-step immunochromatographic test for the rapid, qualitative detection of
one or more of the following: Cannabinoids (THC), Opiates, Amphetamine, Cocaine, Phencyclidine, Tricyclic Antidepressants,
Barbiturates, Methadone, Benzodiazepines, Propoxyphene, Methamphetamine/ 3,4 Methylenedioxymethamphetamine and Oxycodone
in human urine. It is not for over-the-counter sale. The test detects drug classes at the following cutoff concentrations:
THC
OPI2
OPI3
AMP
COC
PCP
TCA

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Cannabinoids (11-nor-9-carboxy-∆ -THC)
Opiates (Morphine)
Opiates (Morphine)
Amphetamine (d-Amphetamine)
Cocaine (Benzoylecgonine)
Phencyclidine (Phencyclidine)
Tricyclic Antidepressants (Desipramine)

50 ng/mL
2000 ng/mL
300 ng/mL
1000 ng/mL
300 ng/mL
25 ng/mL
300 ng/mL

BAR
MTD
BZO
PPX
MAMP
MDMA
OXY

Barbiturates (Butalbital)
Methadone (Methadone)
Benzodiazepines (Nordiazepam)
Propoxyphene (Norpropoxyphene)
Methamphetamine (d-Methamphetamine)
3,4 Methylenedioxymethamphetamine

Oxycodone (Oxycodone)

200 ng/mL
300 ng/mL
300 ng/mL
300 ng/mL
1000 ng/mL
1500 ng/mL
100 ng/mL

THE PROFILE-II/VERDICT-II DRUGS OF ABUSE TEST PROVIDES 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), HIGH
PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) OR LIQUID CHROMATOGRAPHY/TANDEM MASS
SPECTROMETRY (LC/MS/MS) ARE THE PREFERRED CONFIRMATORY METHODS. CLINICAL CONSIDERATION AND
PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT, PARTICULARLY WHEN
PRELIMINARY POSITIVE RESULTS ARE OBTAINED.
2. SUMMARY AND EXPLANATION OF THE TEST
Qualitative PROFILE-II / VERDICT-II Drugs of Abuse screens utilize a one-step, solid-phase immunoassay technology to provide a
very rapid test requiring no instrumentation. This test may be used to screen urine samples for one or more of the following drug
classes prior to confirmatory testing:
Marijuana (THC) is a hallucinogenic drug derived from the hemp plant.
collectively known as Cannabinoids.

Marijuana contains a number of active ingredients

Opiates (OPI) are a class of natural and semi-synthetic sedative narcotic drugs that include morphine, codeine and heroin.
The “Amphetamines” are a group of drugs that are central nervous system stimulants. This group includes „amphetamine‟ and
„methamphetamine‟, and related designer drugs like „3,4 Methylenedioxymethamphetamine‟, (better known as Ecstasy or MDMA a
psychoactive drug with hallucinogenic effects). The drug „Amphetamine‟ (d-amphetamine) is detected on the device only at the
(AMP) position. Both the designer drug Ectasy (MDMA) „Methylenedioxymethamphetamine‟ and methamphetamine (dmethamphetamine) are detected on the device only at the (MAMP) position.
Cocaine (COC) is a central nervous system stimulant. Its primary metabolite is benzoylecgonine.

1

Phencyclidine (PCP) is a hallucinogenic drug.
Tricyclic Antidepressants (TCA) are a group of structurally related prescription drugs that are used to manage depression.
Barbiturates (BAR) are a group of structurally related prescription drugs that are used to reduce restlessness and emotional tension,
induce sleep and to treat certain convulsive disorders.
Methadone (MTD) is a synthetic opioid used clinically as a maintenance drug for opiate abusers and for pain management.
Benzodiazepines (BZO), a group of structurally related central nervous system depressants, are primarily used to reduce anxiety and
induce sleep.
Propoxyphene (PPX) is a narcotic analgesic. It‟s primary metabolite is norpropoxyphene. 3
Oxycodone (Oxycontin®, Percodan®, Percocet®, etc) is a semi synthetic narcotic analgesic that is prescribed for moderately severe
pain. It is available in both standard and sustained release oral formulations. Oxycodone is metabolized to oxymorphone and
noroxycodone.
Many factors influence the length of time required for drugs to be metabolized and excreted in the urine. A variety of factors influence
the time period during which drug metabolites are detected in urine; the rate of urine production, the volume of fluid consumption, the
amount of drug taken, the urine pH, and the length of time over which drug was consumed. Drinking large volumes of liquid or using
diuretics to increase urine volume will lower the drug concentration in the urine and may decrease the detection period. Although the
detection period for these drugs varies widely depending upon the compound taken, dose and route of administration and individual
rates of metabolism, some general times have been established and are listed below. 1-4, 6
Drug
THC
Single Use
Chronic, Use

Opiates
Heroin
Morphine
Codeine

Detection Period
1-7 days
Less than 30 days
typical

1 day
1-3 days
1-3 days

Drug
Detection Period
Tricyclic Antidepressants 1-7 days
Barbiturates
Short-Acting
Long-Acting

up to 6 days
up to 16 days

Methadone

1-3 days

Benzodiazepines

1-12 days

Amphetamine
Acid Conditions
1-3 days
Alkaline Conditions 3-10 days

Methamphetamine/MDMA
Acid Conditions
1-3 days
Alkaline Conditions
3-10 days

Cocaine Metabolite

Propoxyphene

up to 1 week

Oxycodone

1-3 days

PCP
Single Use
Chronic Use

Up to 5 days
1 to 3 days typical
1-8 days
Up to 4 weeks

The LFAS is a lateral flow strip with impregnated reagent test pads that detect specific analytes in human urine. The analytes detected
are Oxidants and Nitrites. The strip also approximates the pH and specific gravity values. Urine samples with „abnormal‟ values
should be submitted to a reference laboratory for additional testing.
Oxidants The detection is based on the oxidative activity of compounds (e.g. chromate salts and/or Bleach) that catalyze the oxidation
of an indicator by an organic hydroperoxide producing a blue/orange color. The color intensity is directly proportional to the
concentration of Oxidants present in the sample and is observed visually and compared to the color comparator chart to obtain a result.

2

Nitrites The test is based on the principles of the Griess reaction for the detection of Nitrites. The test pad contains an amine and a
coupling component. A red/orange colored azo compound is obtained by diazotization and subsequent coupling. The color intensity is
directly proportional to the concentration of Nitrites present in the sample and is observed visually and compared to the color
comparator chart to obtain a result.
pH The test paper contains indicators that change colors between pH 2 and pH 11. The color scale gives an approximate indication for
pH values between those levels.
Specific Gravity The test pad reacts with ions in urine to indicate concentrations from 1.000 to 1.020. The color changes range from
dark green with low ionic concentrations through green to yellow/orange in urines with high ionic concentrations. The color is
observed visually and compared to the color comparator chart to obtain an approximate result.
3. PRINCIPLES OF THE PROCEDURE
The PROFILE-II/VERDICT-II Drugs of Abuse Test is a one-step, competitive, membrane-based immunochromatographic assay. A
single urine sample can be evaluated for the presence of each of the specified classes of drug(s) in a single device. The device consists
of antibody-colloidal gold, drug-conjugates and a control line.
1. ANTIBODY-COLLOIDAL GOLD Mouse monoclonal drug antibodies were developed. Each antibody only binds drug(s) from
the drug class tested. Antibody-colloidal gold solutions were prepared by absorbing each of the individual monoclonal antibodies to
colloidal gold. The colloidal gold solutions were applied to the sample well pad in the drugs of abuse test.
2. DRUG-CONJUGATES Drug from the class tested was individually conjugated to bovine serum albumin (BSA) or IgG. Each
drug conjugate was immobilized as a line at a labeled location on the membrane strip.
3. CONTROL LINE Each test strip has anti-mouse immunoglobulin antibody immobilized as a line on the membrane at the CTRL
location on the device window. The anti-mouse immunoglobulin antibody can bind to any of the mouse antibodies coated on the
colloidal gold.
The device can be used to detect specific class(es) of drug(s) in urine because drug(s) in the urine and the drug(s) conjugated to the
protein compete to bind to the antibody-colloidal gold in a highly specific reaction. When the urine sample is placed in the sample
well(s), the dried antibody-colloidal gold on the sample pad(s) dissolves and the urine wicks up the white strips carrying the reddishpurple antibody-colloidal gold as a solution with it.
Negative Samples
When no drug(s) is present in the urine sample, the reddish purple antibody-colloidal gold solutions migrate along the strip then binds
to the appropriate drug conjugate immobilized on the membrane. The binding of the antibody-colloidal gold to the drug conjugate
generates an easily visible reddish-purple line at each of the labeled locations in the result window. Negative results can be reported as
soon as the drug and control lines are visible.
Positive Samples
When drug(s) is present in the urine sample the antibody-colloidal gold binds to the drug(s) before it migrates along the strip. When
the antibody-colloidal gold binds to the drug(s) in the urine, it cannot bind to the drug conjugate immobilized on the membrane and no
line is generated at the drug-specific location in the result window. Read positive results at 5 minutes. The control line should be
present for the test to be valid.
CTRL Line
Each test strip has an internal procedural control. A line must form at the Control (CTRL) position in the result window to indicate
that sufficient sample was used and that the reagents are migrating properly. If a Control line does not form, the test is invalid. A
Control line forms when the antibody-colloidal gold binds to the anti-mouse immunoglobulin antibody immobilized on the membrane
at the CTRL location(s) near the top of the device window.

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4. MATERIALS PROVIDED/STORAGE CONDITIONS
Each PROFILE-II/VERDICT-II Drugs of Abuse Test contains all the reagents necessary to test one urine sample simultaneously for
one or more drugs.
1.
2.

The test device contains one or more test strips composed of a membrane strip coated with drug conjugate and a pad coated with
antibody dye complexes in a protein matrix.
The test device may contain a membrane strip laminated with Adulterant test pads for testing the presence of Oxidants and
Nitrites, as well as determining approximate values of Specific Gravity and pH in human urine. The LFAS test strip is not
contained in every PROFILE-II/VERDICT-II product.

25 Test Kit Contents-Device Only
1. Twenty-five (25) test devices in individual foil packages containing a disposable 100 µL sample pipette.
2. One reference guide.
3. For LFAS products only, five color comparator charts.
25 Test Kit Contents-Test System
The PROFILE Drugs of Abuse Test System kit contains twenty-five (25) individually bagged test systems and one reference guide.
Test System bag Contents
1. One (1) test device in a foil package containing a disposable 100 µL sample pipette.
2. For LFAS products only, one color comparator chart.
3. Split Specimen Kit containing the following:
One (1) calibrated collection container with temperature strip.
Two (2) specimen bottles.
One (1) specimen transport (Bio-Hazard) bag.
On-Site Screening and Laboratory Confirmation Forms may be included if requested.
Storage Conditions
The kit, in its original packaging, should be stored at 2-25°C (36-77°F) until the expiration date on the label.
5. PRECAUTIONS
1.
2.
3.
4.
5.
6.
7.
8.

Urine specimens and all materials coming in contact with them should be handled and disposed of as if infectious and capable of
transmitting infection. Never pipette by mouth and avoid contact with broken skin.
Avoid cross-contamination of urine samples by using a new urine specimen container and pipette for each urine sample.
The device should remain in its original sealed foil pouch until ready to use. If the pouch is damaged, do not use the test.
Do not store the test kit at temperatures above 25°C (77°F).
If devices have been stored refrigerated, bring to ambient temperature (18-25°C/ 64-77°F) prior to opening foil pouch.
Do not use tests after the expiration date printed on the package label.
The drug screen portion of the device is for in vitro diagnostic use only. The LFAS strip is for Forensic/Toxicology use only.
If any of the lines formed are outside the arrow indicated by the drug name, the test is invalid.

6. SAMPLE COLLECTION AND PREPARATION
The urine sample should be collected in a clean glass or plastic container. Approximately 100 µL is required for each sample well.
Collection of 45 mL of urine is more than sufficient for initial and subsequent testing. No preservatives should be added. Urine may be
tested immediately following collection. The specimen may be refrigerated if testing is going to be delayed for more than a day. Urine
may be frozen for longer storage. Stored urine must be brought to ambient temperature (18 to 25°C/64 to 77°F) and mixed well to
assure a homogeneous sample prior to testing.
7. MATERIALS REQUIRED BUT NOT PROVIDED
1.
2.
3.
4.

External controls
Timer
A Urine collection container is not provided with the „Device Only‟ 25 Test Kit.
Specimen containers, external controls, disposable gloves and urine temperature strips are available from MEDTOX Diagnostics,
Inc.

4

8. TEST PROCEDURE
1.
2.

3.
4.

Open one pouch for each sample to be tested and label the device with the patient or sample identification (ID).
(You may notice a reddish-purple color in the sample well. This is normal, do not discard the test).
Apply 100 µl of urine to sample well as follows:
• Hold the 100 µl sample pipette by the upper bulb.
• Lower the pipette stem into the urine sample.
• Squeeze the upper bulb then release it. This motion will draw 100 µl of urine into the stem. The urine sample should reach
the top of the stem, and a drop or two should overflow into the middle bulb, if not, repeat this process.
• Dispense the urine into the sample well by squeezing the upper bulb. This will empty the stem delivering 100 µL of sample.
Excess urine in the middle bulb should remain in the bulb.
Repeat Step 2 for each additional sample well (for multi-strip devices).
Read the results at 5 minutes after application.
NOTE: For all tests except OXY, read results at 5 minutes or within 15 minutes of the sample application. The test result
after 15 minutes may not be consistent with the original reading.
For OXY only, read results at 5 minutes. The test result after 5 minutes may not be consistent with the original
reading.

9. READING THE TEST RESULTS
Negative: The appearance of both a reddish-purple Control (CTRL) line and a specific drug line indicates a negative test result. The
color intensities of the Control line and a specific drug line may not be equal; any reddish-purple line visible at 5 minutes
indicates a negative test result. Line intensity will vary from test to test.
Non-Negative:

Invalid:

The appearance of both a reddish-purple Control (CTRL) line and the absence of a line next to a specific drug name
at 5 minutes indicates a preliminary positive test result for that drug. Occasionally a white line (line lighter than the
background of the strip) may appear next to a specific drug name. This indicates a preliminary positive test result
for that drug.

The absence of a reddish-purple Control (CTRL) line indicates the test is invalid. The urine sample should be retested on a
new device. If the second test is also invalid, send the urine sample to a reference laboratory for additional testing.

10. INTERPRETATION OF TEST RESULTS
A NEGATIVE test result for a specific drug indicates that the sample does not contain the drug/drug metabolite above the cutoff level.
A NON-NEGATIVE test result for a specific drug indicates that the sample may contain drug/drug metabolite near or above the cutoff
level. It does not indicate the level of intoxication or the specific concentration of drug in the urine sample. Examples of Negative and
Non-Negative results are shown below.

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There are other possible results depending on the drug or combination of drugs present in the urine sample.

11. QUALITY CONTROL
An internal procedural control is included on each device. A line must form at the Control (CTRL) position in the result window to
indicate that the proper sample volume was used and that the reagents are migrating properly. If a Control line does not form, the test
is considered invalid. The Control line consists of immobilized anti-mouse antibody that reacts with the antibody-colloidal gold as it
passes this region of the membrane. Formation of a visible line verifies the Control line antibody antigen reaction occurred. This line
may be considered an internal negative procedural control. In addition, if the test has been performed correctly and the device is
working properly, the background will clear such that result lines are distinct. The cleared background may be considered an internal
positive procedural control. The visible Control line (CTRL) should always be present regardless of whether drug is absent or present
in the sample.
The purpose of quality control in laboratory testing is to ensure accuracy, reliability of results and to detect errors. Because the devices
are self-contained, single use tests, traditional quality control programs do not apply. The Quality Control program MEDTOX
recommends for these non-instrumented test devices includes a combination of the internal device controls and external controls to
ensure accuracy, reliability and to detect possible errors. The on-board reactive device controls may be one aspect of the quality
program utilized by a laboratory to satisfy the daily quality control requirement established by the Laboratory Director. Another aspect
of a quality control program includes an external negative control containing no drug and a positive drug control challenging to the
assay cutoff concentration. These controls may be used to initially test each shipment of product received by the laboratory or to verify
appropriate storage conditions and long-term stability of the test reagent. To follow good laboratory practices, we recommend that the
user document the receipt of each new lot number of devices, the results of external controls performed initially and periodically
thereafter, and the results of the internal controls within each device.
It is the responsibility of each Laboratory Director to demonstrate and document the validity of the alternate QC procedure they
choose to use in their laboratory. For additional information or forensic and workplace testing requirements, users should contact and
follow the appropriate federal, state, and local guidelines. Quality control materials are available from MEDTOX and commercial
sources. Contact MEDTOX for further information.

6

12. LIMITATIONS OF THE PROCEDURE
1.
2.
3.
4.
5.

The PROFILE-II/VERDICT-II Drugs of Abuse Test is only for use with unadulterated human urine samples. Urine samples
which are either extremely acidic (below pH 4.0) or basic (above pH 9.0) may produce erroneous results.
A positive result for any drug(s) does not indicate or measure intoxication. It only indicates the presence of specific drug(s) in the
urine specimen.
Test results interpreted after 15 minutes (after 5 minutes for OXY) may not be consistent with the original result obtained at 5
minutes.
The PROFILE-II/VERDICT-II Drugs of Abuse Test was not evaluated in point-of-care settings (except OXY clone was evaluated
in point-of-care settings).
There is a possibility that other substances and/or factors, e.g. technical or procedural errors, may interfere with the test and cause
false results.

LFAS Strip
The purpose of the adulteration strip is to screen for abnormal conditions in human urine samples, such as dilution or the addition of
drug-test interfering substances. Occasionally medications may discolor the urine, and make it difficult to read the result. When in
doubt send the urine sample to a reference laboratory for additional testing.
Oxidant
Nitrites, acting as oxidizing agents in solution, will produce a blue/green color change on the Oxidant pad.
Nitrite
Abnormal results can be caused by the presence of diagnostic or therapeutic dyes in the urine. Very high concentrations of oxidant
such as 80% bleach will produce a brown color change on the Nitrite pad.
13. EXPECTED VALUES
The Substance Abuse and Mental Health Services Administration (SAMHSA) recommends the following
screening test cutoffs:
THC
OPI
AMP
COC
PCP
MAMP

9

11-nor-9-carboxy-∆ -THC
Morphine
Amphetamine
Benzoylecgonine
Phencyclidine
Methamphetamine

50 ng/mL
2000 ng/mL
1000 ng/mL
300 ng/mL
25 ng/mL
1000 ng/mL

There are no SAMHSA recommended screening levels for tricyclic antidepressants, benzodiazepines, methadone, barbiturates,
MDMA, propoxyphene and oxycodone and/or their metabolites.
The PROFILE-II/VERDICT-II Drugs of Abuse Test qualitatively detects THC, opiates, amphetamines, cocaine, phencyclidine,
tricyclic antidepressants, barbiturates, methadone, benzodiazepines, propoxyphene, methamphetamine/MDMA and oxycodone and/or
their metabolites as listed (See Sensitivity).
LFAS Test:
Urines that produce an abnormal result on the LFAS adulteration strip should be sent to a reference laboratory for more definitive
testing to determine if the urine may be dilute, substituted, invalid and/or adulterated.
14. PERFORMANCE CHARACTERISTICS
Sensitivity
The PROFILE-II/VERDICT-II Drugs of Abuse Test detects one or more of the following drugs at cutoff levels listed below. Cutoffs
for cannabinoids (THC), opiates (OPI2), amphetamines, cocaine metabolite, phencyclidine, and methamphetamines are based on
SAMHSA recommendations for screening of these drugs in human urine. The opiate (OPI3) test, if present, detects opiates below the

7

SAMHSA recommendations for screening of opiates in human urine. There are no SAMHSA recommended screening cutoff levels
for propoxyphene, MDMA, barbiturates, benzodiazepines, methadone, tricyclic antidepressants and oxycodone.
9
THC
11-nor-9-carboxy-∆ -THC
50 ng/mL
OPI2
Morphine
2000 ng/mL
OPI3
Morphine
300 ng/mL
AMP
Amphetamine
1000 ng/mL
COC
Benzoylecgonine
300 ng/mL
PCP
Phencyclidine
25 ng/mL
TCA
Tricyclic Antidepressants (Desipramine)
300 ng/mL
BAR
Barbiturates (Butalbital)
200 ng/mL
MTD
Methadone (Methadone)
300 ng/mL
BZO
Benzodiazepines (Nordiazepine)
300 ng/mL
PPX
Propoxyphene (Norpropoxyphene)
300 ng/mL
MAMP
Methamphetamine
1000 ng/mL
MDMA
Methylenedioxymethamphetamine
1500 ng/mL
OXY
Oxycodone
100 ng/mL

Accuracy
A panel of naturally metabolized urine samples for the following drug(s) was analyzed using the PROFILE-II/VERDICT-II Drugs of
Abuse Test and the Boehringer Mannheim qualitative CEDIA® assay or the ROCHE ABUSCREEN ONLINE® for each drug and the
results were compared. Results are shown in the following tables.
ACCURACY COMPARED TO THE BOEHRINGER MANNHEIM QUALITATIVE CEDIA® or
THE ROCHE ABUSCREEN ONLINE® II ASSAYS
CEDIA MULTI-LEVEL THC (50 ng/mL cutoff)
PROFILE-II/VERDICT-II
Positive
THC (50 ng/mL cutoff)
Positive 194
Negative 10
TOTAL 204

Negative
3
477
480

TOTAL
197
487
684

Overall agreement: 98% (671/684). Samples having discrepant results were analyzed by GC/MS. The three false positive samples
were found to contain 16, 28, and 32 ng/mL while the ten false negative samples contained 32, 35, 41, 42, 46, 46, 49, 50, 50, and 90
ng/mL.
ROCHE ABUSCREEN ONLINE®-II OPIATE (2000 ng/mL cutoff)
PROFILE-II/VERDICT-II
Positive
OPI (2000 ng/mL cutoff) Positive
68
Negative
0
TOTAL
68

Negative
0
89
89

TOTAL
68
89
157

Overall agreement: 100% (157/157)
CEDIA OPIATE (300 ng/mL cutoff)
PROFILE-II/VERDICT-II
Positive
OPI (300 ng/mL cutoff)
Positive
133
Negative
0
TOTAL 133

Negative
1
550
551

TOTAL
134
550
684

Overall agreement: >99% (683/684). The discrepant sample was analyzed by GC/MS. The one false positive sample did not contain
morphine or codeine detectable at the GC/MS cutoff of 300 ng/mL.

8

CEDIA AMPHETAMINE (1000 ng/mL cutoff)
PROFILE-II/VERDICT-II
Positive
AMP(1000 ng/mL cutoff) Positive
64
Negative
2
TOTAL
66

Negative
0
618
618

TOTAL
64
620
684

Overall agreement: >99% (682/684). Samples having discrepant results were analyzed by GC/MS. The two false negative samples
contained amphetamine at 2353 and 3569 ng/mL.
CEDIA COCAINE (300 ng/mL cutoff)
PROFILE-II/VERDICT-II
Positive
COC (300 ng/mL)
Positive
96
Negative
2
TOTAL
98

Negative
8
578
586

TOTAL
104
580
684

Overall agreement: 99% (674/684). Samples having discrepant results were analyzed by GC/MS. Of the eight false positive samples
one contained 151 ng/mL while seven did not contain cocaine metabolite detectable at the GC/MS cutoff of 150 ng/mL. The two false
negative samples contained cocaine metabolite at 688 and 666 ng/mL.
CEDIA PHENCYCLIDINE (25 ng/mL cutoff)
PROFILE-II/VERDICT-II
Positive
PCP (25 ng/mL)
Positive
56
Negative
1
TOTAL
57

Negative
2
625
627

TOTAL
58
626
684

Overall agreement: >99% (681/684). Samples having discrepant results were analyzed by GC/MS. The two false positive samples did
not contain phencyclidine detectable at the GC/MS cutoff of 25ng/mL. The one false negative sample contained phencyclidine at 28
ng/mL.
RELATIVE SENSITIVITY AND SPECIFICITY COMPARED TO THE BOEHRINGER MANNHEIM
QUALITATIVE CEDIA® or THE ROCHE ABUSCREEN ONLINE® II ASSAYS
(THC, Opiates, Amphetamine, Cocaine, and PCP)
Relative Sensitivity
THC 95% (194/204)
OPI2 100% (68/68)
OPI3 100% (133/133)
AMP 97% (64/66)
COC 98% (96/98)
PCP 98% (56/57)

Relative Specificity
99% (477/480)
100% (89/89)
>99% (550/551)
100% (618/618)
99% (578/586)
>99% (625/627)

ACCURACY COMPARED to GC/MS

THC
OPI2
OPI3
AMP
COC

PCP

Positive
Negative
Positive
Negative
Positive
Negative
Positive
Negative
Positive
Negative

Positive
Negative

PROFILE-II/VERDICT-II
48
52
47
0
50
50
48
52
49
51

GC/MS
50
50
47
0
50
50
50
50
50
50

49
51

50
50

9

Values for Discrepant
Samples (ng/mL)
35 and 46
No Discrepants
No Discrepants
2353 and 3569
666

28

Precision (THC, Opiates, Amphetamine, Cocaine, and PCP)
Performance around the specific cutoff for each drug was measured by testing standard drug solutions diluted in drug-free urine in
replicates of 20 each on 3 different days by 3 operators. Twenty replicates of drug-free urine were also tested on each day. At 25%
above the cutoff, the precision of each assay was as follows: THC=95%, OPI2= 96.7%, OPI3=100%, AMP=100%, COC=100%, and
PCP=100%.
Reproducibility (THC, Opiates 300, Amphetamine, Cocaine, and PCP)
A panel of 55 naturally metabolized human urine samples was prepared. All samples in the panel had been screened for the presence
or absence of THC, OPI, AMP, COC, and PCP. In addition, each of the 55 samples had also been quantitated by GC/MS conducted at
SAMHSA cutoffs for positive samples or at limit of quantitation for negative samples to determine the concentration of a specific
drug. Five of the 55 samples were drug-free negatives and 50 of the samples were positive for one or more of the five drugs. The
concentration of primary metabolite in the positive samples was between 66 and 198 ng/mL for THC; 464 and 2000 ng/mL for OPI3;
1056 and 4622 ng/mL for AMP; 487 and 1342 ng/mL for COC; and 32 and 109 ng/mL for PCP. The panel was used to evaluate the
lot-to-lot and lab-to-lab reproducibility.

10

Lot-to-Lot Reproducibility (THC, Opiates 300, Amphetamine, Cocaine, and PCP)
Three aliquots of each of the 55 samples were prepared and each of the three sets of aliquots was coded and used to evaluate the
performance of one of three lots of drug tests for the five drugs above. There was one incorrect result (a false negative on an
amphetamine low positive sample) on the 825 tests for a reproducibility of >99%.
Lab-to-Lab Reproducibility (THC, Opiates 300, Amphetamine, Cocaine, and PCP)
Three aliquots of each of the 55 samples were prepared and each of the three sets of aliquots was tested by one of three study
participants using one lot of the five drug test panel above. There was >99% agreement between the three participants. Overall, there
were three incorrect results, two incorrect results for OPI3 (one false negative on an opiate low positive sample and one false negative
on an opiate high positive sample) and one incorrect result for PCP (one false negative a low positive sample), on the 825 tests.
Reproducibility (Opiates 2000)
A panel of 25 naturally metabolized human urine samples was prepared. All samples in the panel had been screened for the presence
or absence of opiates. In addition, each of the positive samples had also been quantitated by GC/MS conducted at SAMHSA cutoff
for positive samples to determine the concentration of morphine and codeine. The concentration of morphine and/or codeine in the
positive samples was between 2000 and 6000 ng/mL. The panel was used to evaluate Opiates 2000 for lot-to-lot and lab-to-lab
reproducibility. There were no incorrect results on the 75 tests (25 samples x 3 lots) for a lot-to-lot reproducibility of 100%. There
were no incorrect results on the 75 tests (25 samples x 3 study participants) for a lab-to-lab reproducibility of 100%.
Accuracy (Propoxyphene)
One-hundred forty one (141) clinical samples were evaluated by the Roche Abuscreen OnLine Propoxyphene assay, using a 300
ng/mL cut off. Sixty (60) samples were found to be negative and eighty-one (81) samples were found to be positive by the Roche
method. Three aliquots of each sample were prepared, and assayed by three operators in a masked manner. There was no significant
difference in the results obtained by the three operators, therefore the results of all three operators are included in the table. Results of
this comparison are as follows:

PROFILE-II/VERDICT-II
PPX (300 ng/mL cutoff)

OnLine Positive
238
5

OnLine Negative
0
180

* GC/MS results are 390, 441, 499, 536 and 679 ng/mL
In addition to the 141 clinical samples, eight additional clinical samples containing only norpropoxyphene were diluted with drug-free
urine in order to obtain an adequate number of samples that had concentrations of drug that were challenging to the cutoff. These eight
diluted samples, and the 141 clinical samples described above were analyzed by GC/MS for propoxyphene and norpropoxyphene. The
level of quantitation of the GC/MS was 30 ng/mL. Only ten of the samples contained propoxyphene, and each of these samples had
norpropoxyphene levels greater than 1,647 ng/mL. As in the study above, three aliquots of the 149 samples were prepared, coded, and
assayed by three operators in a masked manner. There was no significant difference in the results obtained by the three operators,
therefore the results of all three operators are included in the comparison table.
GC/MS Range (ng/mL)
Number of samples
Positive
Negative

None detected
60
0
180

150-265
8 (Diluted samples)
12
12

339-450
7
19
2

>472
74
219
3

Sensitivity/Precision/Distribution of Random Error (Propoxyphene)
Performance around the specific cut-off of 300 ng/ml for norpropoxyphene was evaluated by testing standard drug solutions diluted in
drug-free urine in triplicate on 5 different days by 3 operators. Drug-free urine was also tested on each day. There was no significant
difference in the results of the three operators so the results were combined and are shown in the following table.

11

Conc. (ng/mL)
0
30
75
150
225
300
375
450
600

Number Tested
45
45
45
45
45
45
45
45
45

Norpropoxyphene – Cut-off = 300 ng/mL
Positive
Negative
0
45
0
45
1
44
9
36
16
29
37
8
42
3
44
1
45
0

% Agreement
100
100
98
80
64
82
93
98
100

Accuracy (Methamphetamine and MDMA)
A panel of naturally metabolized urine samples was analyzed using the PROFILE-II/VERDICT-II PPX/MAMP-MDMA and the
GC/MS assay for methamphetamine and MDMA. The results obtained in the two procedures are shown in the following tables.
GC/MS Methamphetamine (limit of quantitation 50 ng/mL)
PROFILE-II/VERDICT-II
MAMP (1000 ng/mL cut-off)

Positive
Negative
TOTAL

Positive
56
2
58

Negative
0
56
56

TOTAL
56
58
114

Overall agreement: >98% (112/114). Samples having discrepant results were analyzed by GC/MS. The false negative samples
contained methamphetamine at 1056 ng/mL and at 1136 ng/mL.
GC/MS MDMA (limit of quantitation 50 ng/mL)
PROFILE-II/VERDICT-II
MDMA (1500 ng/mL cut-off)

Positive
Negative
TOTAL

Positive
19
4
23

Negative
1
57
58

TOTAL
20
61
81

Percent Agreement of MAMP-MDMA Compared to GC/MS

MAMP
MDMA

POSITIVE
97% (56/58)
83% (19/23)

NEGATIVE
100% (56/56)
98% (57/58)

Sensitivity/Precision MAMP-MDMA
Performance for methamphetamine and MDMA was evaluated by testing standard drug solutions diluted in drug-free urine in
duplicates of 8 drug concentrations on 5 different days by 3 operators. Drug-free urine was also tested on each day. The complete
results for both drugs are shown in the tables below.

12

Conc. (ng/mL)
0
100
250
500
750
1000
1250
1500
2000

Methamphetamine Cut-off = 1000 ng/mL
MDMA Cut-off= 1500 ng/mL
No. Tested (+)
(-)
% Agreement
Conc(ng/mL)
No. Tested
(+)
(-)
30
0
30
100
0
30
0
30
30
0
30
100
500
30
0
30
30
0
30
100
750
30
0
30
30
26
4
87
1000
30
12
18
30
27
3
90
1250
30
23
7
30
28
2
93
1500
30
25
5
30
29
1
97
2000
30
30
0
30
30
0
100
2500
30
30
0
30
30
0
100
3000
30
30
0

% Agreement
100
100
100
60
77
83
100
100
100

Reproducibility (MAMP-MDMA)
A panel of 18 spiked human urine samples, comprised of drug-free and drug standard samples, was prepared. The panel was examined
by 3 operators, once a day for 5 days. The concentration of methamphetamine and MDMA had been quantitated by GC/MS in each of
the 18 samples. There was 100% agreement between the three operators over the 5 day period at 0 ng/mL, 1500 ng/mL (cut-off +
50%) and 2000 ng/mL (cut-off + 100%) for methamphetamine. There was also 100% agreement between the three operators over the
5 day period for 0 ng/ml, 2000 ng/mL (cut-off +33%), 2500 ng/mL (cut-off + 67%) and 3000 ng/mL (cut-off + 100%) for MDMA.
Accuracy (Tricyclic Antidepressants, Barbiturates, Methadone and Benzodiazepines)
The accuracy was evaluated by assaying a coded panel of clinical urine samples containing varying concentrations of drugs and
comparing the results to validated methods. A validated HPLC assay measured tricyclic antidepressant levels. Validated GC/MS
assays measured barbiturates, methadone and benzodiazepines levels. Results are shown in the following tables.
ACCURACY COMPARED TO GC/MS OR HPLC
(Tricyclic Antidepressants, Barbiturates, Methadone and Benzodiazepines)
DRUG CLASS
Tricyclic
Antidepressants

Concentration Range
(ng/mL)

Number
of Samples

PROFILE-II/VERDICT-II
Results

305 – 19224
228, 235, 238, 238, 246

50
5

49/50 Positive
5/5 Negative

Only one tricyclic antidepressant positive sample containing a combination of nortriptyline and amitriptyline for a combined tricyclic
antidepressant concentration of 519 ng/mL tested negative.
Barbiturates
Phenobarbital

201 – 27776
155, 155, 156, 158, 161

36
5

36/36 Positive
5/5 Negative

Butalbital

240 - 3814
109, 151, 194

27
3

27/27 Positive
3/3 Positive

Pentobarbital

264

1

1/1 Positive

Methadone

306 – 70560
224, 226, 227, 230, 232

57
5

57/57 Positive
5/5 Negative

Benzodiazepines

303 – 30813
234, 236, 238, 250, 283

57
5

57/57 Positive
5/5 Negative

Additionally, the accuracy was evaluated in comparison to a validated HPLC assay for tricyclic antidepressants and to the Roche
Diagnostics Sytems, Inc, ABUSCREEN ONLINE® assays for barbiturates, methadone and benzodiazepines. A panel of clinical urine
samples was analyzed and the results obtained in the procedures were compared. Results are shown in the following tables.

13

ACCURACY COMPARED TO THE ROCHE ABUSCREEN ONLINE® II OR HPLC ASSAYS
(Tricyclic Antidepressants, Barbiturates, Methadone and Benzodiazepines)
HPLC Tricyclic Antidepressants (25 ng/mL limit of quantitation)
PROFILE-II/VERDICT-II
TCA (300 ng/mL cutoff)
Desipramine Test

Positive
49
1
50

Positive
Negative
Total

Negative
0
45
45

Total
49
46
95

Overall agreement: 99% (94/95). Only one tricyclic antidepressant positive sample containing a combination of nortriptyline (499
ng/mL) and amitriptyline (20 ng/mL) for a combined tricyclic antidepressant concentration of 519 ng/mL tested negative.
ABUSCREEN ONLINE® II Barbiturates Result (Secobarbital)
(300 ng/mL cutoff)
PROFILE-II/VERDICT-II
BAR (200 ng/mL cutoff)
Butalbital Test

Positive
62
0
62

Positive
Negative
Total
Overall agreement: 100% (107/107).

Negative
0
45
45

Total
62
46
107

ABUSCREEN ONLINE® II Methadone Result
(300 ng/mL cutoff)
PROFILE-II/VERDICT-II
MTD (300 ng/mL cutoff)
Methadone Test

Positive
Negative
Total

Positive
55
0
55

Negative
0
45
45

Total
55
45
100

Overall agreement: 100% (100/100).

PROFILE-II/VERDICT-II
BZO (300 ng/mL cutoff)
Nordiazepam Test

ABUSCREEN ONLINE® II Benzodiazepines Result
(300 ng/mL cutoff)
Positive
Negative
Total
Positive
57
0
57
Negative
0
45
45
Total
57
45
102

Overall agreement: 100% (102/102).
PERCENT AGREEMENT COMPARED TO ROCHE ABUSCREEN
ONLINE ASSAYS OR HPLC
(Tricyclic Antidepressants, Barbiturates, Methadone and Benzodiazepines)

Tricyclic Antidepressants
Barbiturates
Methadone
Benzodiazepines

POSITIVE
98% (49/50)
100% (62/62)
100% (55/55)
100% (57/57)

NEGATIVE
100% (45/45)
100% (45/45)
100% (45/45)
100% (45/45)

Sensitivity/ Precision/ Distribution of Random Error (Tricyclic Antidepressants, Barbiturates, Methadone and Benzodiazepines)
Performance around the specific cutoff for each drug was evaluated by testing standard drug solutions diluted in drug-free urine in
triplicate on 5 different days by 3 operators. Drug-free urine was also tested on each day. Operator-to-operator agreement was
excellent, therefore, the data were combined and summarized in the following tables.

14

Conc. (ng/mL)
Negative
30
75
150
225
300
375
450
600

Tricyclic Antidepressants (Desipramine) Cutoff = 300 ng/mL
Number Tested
Positive
Negative
%Agreement
45
0
45
100
45
2
43
96
45
17
28
62
45
33
12
73
45
34
11
76
45
40
5
89
45
41
4
91
45
44
1
98
45
45
0
100

Conc. (ng/mL)
Negative
50
100
150
200
250
300

Barbiturates (Butalbital) Cutoff = 200 ng/mL
Number Tested
Positive
Negative
45
0
45
45
0
45
45
0
45
45
12
33
45
43
2
45
45
0
45
45
0

% Agreement
100
100
100
73
96
100
100

Conc. (ng/mL)
Negative
30
75
150
225
300
375
450
600

Methadone (Methadone) Cutoff = 300 ng/mL
Number Tested
Positive
Negative
45
0
45
45
3
42
45
28
17
45
35
10
45
43
2
45
45
0
45
45
0
45
43
2
45
44
1

% Agreement
100
93
62
78
96
100
100
96
98

Conc. (ng/mL)
Negative
30
75
150
225
300
375
450
600

Benzodiazepines (Nordiazepam) Cutoff = 300 ng/mL
Number Tested
Positive
Negative
45
0
45
45
0
45
45
6
39
45
27
18
45
41
4
45
42
3
45
43
2
45
45
0
45
45
0

% Agreement
100
100
87
60
91
93
96
100
100

15

Accuracy in a Point of Care setting (Oxycodone)
The accuracy was evaluated by assaying a panel of blind coded clinical urine samples containing varying concentrations of drugs and
comparing to GC/MS results. The samples were obtained from MEDTOX Laboratories. Samples that screened negative by the
predicate device were not confirmed by GC/MS. Positive samples were confirmed by GC/MS. The GC/MS determination included
Oxycodone and oxymorphone and a weighted concentration using 100% cross-reactivity for Oxycodone and a 50% cross-reactivity
for oxymorphone was calculated. Clinical urine samples containing Oxycodone and oxymorphone at higher concentrations were
diluted with negative urine to obtain the desired number of samples with concentrations below and above the cutoff. The testing was
performed by nine point of care personnel at three sites.
MEDTOX® OXYCODONE Results vs stratified GC/MS Values
Negative by
Near Cutoff Negative
Near Cutoff Positive
High Positive
Concentration up
MEDTOX®
Immunoassay
(Between 50% below
(Between the cutoff
(Greater than 50%
to 50% below the
OXYCODONE
(Predicate
the cutoff and the
and 50% above the
above the cutoff
cutoff
Results
Device)
cutoff concentration)
cutoff concentration)
concentration)
Positive
Negative

0
103

2
5

2
4

6
1

37
1

GC/MS values used to categorize samples in this table are determined by adding together the concentration of Oxycodone plus 50% of
the concentration of oxymorphone, based on the MEDTOX® OXYCODONE cross-reactivity studies.
% Agreement among positives is 96%
% Agreement among negatives is 97%
A second, in-house accuracy study was done using many of the same samples as in the POC study above. Results between the two
studies were similar.
Sensitivity/Precision at One Location (Oxycodone)
Performance around the specific cutoff for Oxycodone was evaluated by testing standard drug solutions diluted in drug-free urine in
triplicate on 6 different intervals by 3 in-house operators. Drug free urine was also tested on each interval. The results were
interpreted at five minutes and are summarized below:
MEDTOX® OXYCODONE Precision Study Results
Concentration of
Number of
Results
sample (ng/mL)
determinations
#Neg / #Pos
0
54
54 / 0
25
54
54 / 0
50
54
50 / 4
75
54
14 / 40
54
4 / 50
100
125
54
1 / 53
150
54
0 / 54
Sensitivity/Precision at Point of Care Sites (Oxycodone)
Performance around the cutoff was evaluated by testing standard drug solutions diluted in drug-free urine at the various concentrations
listed in the following table. 9 POC users at 3 different sites each tested 5 replicates of the 6 levels. The results obtained from the 3
sites, (Site1, Site2, Site3) are listed below:

16

MEDTOX® OXYCODONE Precision Study Results at Point of Care Sites
Concentration of sample
(ng/mL)

Results
#Neg / #Pos

Number of determinations

0

Site 1
15

Site 2
15

Site 3
15

Site 1
15 / 0

Site 2
15 / 0

Site 3
15 / 0

25

15

15

15

15 / 0

15 / 0

15 / 0

50

15

15

15

13 / 2

15 / 0

14 / 1

100

15

15

15

0 / 15

3 / 12

3 / 12

125

15

15

15

0 / 15

2 / 13

1 / 14

150

15

15

15

0 / 15

0 / 15

0 / 15

Unrelated Compounds, Prescription and Over-the-Counter Medications
The following compounds were tested for reactivity. Listed compounds were dissolved in appropriate solvents and then added to
drug-free urine for testing. Unless otherwise noted by a drug name abbreviation such as “AMP” or “BAR” etc., all of the listed
compounds were negative in each of the tests at 100 µg/mL or the highest level tested. If a drug name is followed by an abbreviation
such as “AMP” or “BAR” etc., check the “Related Compounds and Cross Reactants” listing for the drug in question under the
appropriate heading (AMP, BAR, etc.) to find its level of cross-reactivity to that test.
Acecainide (N-Acetylprocainamide)
Allobarbital-BAR
Alprazolam, 1-Hydroxy-BZO
7-Aminoflunitrazepam
Amitriptyline-TCA
Amoxicillin
Ampicillin
Aspartame
Atropine Sulfate
Benzilic Acid
Benzoylecgonine-COC
Brompheniramine
Butabarbital-BAR
Cannabidiol
Carbamazepine
Cephalexin
Chlordiazepoxide
Chlorpheniramine
Clobazam-BZO
Clonidine
Cocaine-COC
Cotinine
Deoxycorticosterone
Desmethylchlordiazepoxide-BZO
Dexamethasone
Diazepam-BZO
Diflunisal
Dimenhydrinate (Dramamine)
Diphenylhydantoin (Phenytoin)-BAR
Doxepin-TCA
EDDP-(Primary metabolite of methadone)
Ephedrine-MAMP
Estrone
Fenfluramine-MAMP
Flunitrazepam-BZO
Furosemide
Glutethimide
Hexobarbital
Hydrochlorothiazide
Hydromorphone-OPI, OXY
l-11-Hydroxy-9-THC
3-Hydroxytyramine
Imipramine-TCA
Isoxsuprine-COC
Labetalol
Lithium carbonate
Lorazepam glucuronide-BZO
Lysergic Acid Diethylamide (LSD)
MDE (MDEA)-MAMP
Meperidine
Mesoridazine
l-Methamphetamine-MAMP

Acetaminophen
Alphenal-BAR
p-Aminobenzoic Acid
Amino glutethimide
Amobarbital-BAR
d-Amphetamine-AMP
Apomorphine
Atenolol
Barbital-BAR
Benzoic Acid
Benzphetamine
Buprenorphine
Butalbital-BAR
Cannabinol
Carbamazepine- 10,11 epoxide
Chloral Hydrate
Chloroquine
Chlorpromazine
Clomipramine
Clorazepate-BZO
Codeine-OPI, OXY
Cyclobenzaprine-TCA
Desalkylflurazepam-BZO
Desmethylflunitrazepam-BZO
Dextromethorphan
Diclofenac
Digoxin
1,3-Dimethylbarbituric acid
Domperidone
Doxylamine
Efavirenz (Sustiva)
Equilin
Ethanol
Fenoprofen
Fluoxetine (Prozac)
Fluvoxamine
Guaiacol Glyceryl Ether
Hippuric acid
Hydrocodone-OPI, OXY
Hydroxybupropion
p-Hydroxyphenobarbital-BAR
Hydroxyzine
Iproniazid
Ketamine
Levorphanol-OPI
Loperamide
Loxapine
Maprotiline-TCA
MDMA
Mephobarbital
Methadone-MTD
Methaqualone

Acetylsalicyclic Acid
Alprazolam-BZO
7-Aminoclonazepam
l-Aminopyrine (4-(dimethylamino) antipyrine)
Amoxapine
l- Amphetamine-AMP
l-Ascorbic Acid
Atomoxetine
Barbituric Acid
Benzocaine (ethyl-4-aminobenzoate)
Benztropine
Bupropion
Caffeine
Captopril
Carisoprodol (Meprobamate)
Chloramphenicol
Chlorothiazide
Chlorprothixene
Clonazepam-BZO
Clozapine-TCA
Cortisone
Cyclopentobarbital-BAR
Desipramine
Desmethylvenlafaxine
Diacetylmorphine-OPI
Diethylpropion
Dihydrocodeine-OPI, OXY
Diphenhydramine
Dopamine
Ecgonine
EMDP-(Secondary metabolite of methadone)
Erythromycin
Ethylmorphine-OPI, OXY
Fentanyl (Synthetic opiate)
Flurazepam
Gentisic Acid (2,5-Dihydroxybenzoic acid)
Haloperidol
Hydralazine
Hydrocortisone
Hydroxyhippuric Acid
4-Hydroxyphencyclidine-PCP
Ibuprofen
(R)-Isoproterenol
Ketoprofen
Lidocaine
Lorazepam-BZO
Lysergic Acid
MDA-AMP
Melanin
Mepivacaine
d-Methamphetamine-MAMP
Methcathinone

17

Methocarbamol
Methylprylon
Mirtazapine
Morphine 3--D-Glucuronide-OPI
Naltrexone-OXY
Naproxen
Nifedipine
Norclomipramine
Nordoxepin-TCA
Normeperidine
Nortriptyline-TCA
Octopamine
Omeprazole
Oxaprosin
Oxolinic Acid
Oxymorphone-OXY
Pentazocine
Phenacetin (Acetophenetidin)
Phenelzine
Phenmetrazine
Phentermine-AMP
Phenylephrine-MAMP
Prazosin
Procaine-MAMP
Promazine-TCA
Propranolol
Pyrilamine
Ranitidine
Salicylic Acid
Serotonin (5-Hydroxytryptamine)
Sulfamethazine
Temazepam-BZO
9-Tetrahydrocannabinol
Thebaine-OPI
Thiopental
Tolbutamide
Triamterene
Trifluoperazine
Tripelennamine
Tyramine
Venlafaxine

Methoxyphenamine
Metoprolol
6-Monoacetylmorphine-OPI
Morphine 6--D-Glucuronide-OPI
Nalorphine-OPI
Niacinamide
Nitrazepam-BZO
Norcodeine-OPI, OXY
Norethindrone
Norpropoxyphene-PPX
Noscapine
Ofloxacin-OPI
Orphenadrine
Oxazepam-BZO
Oxycodone-OXY
Papaverine hydrochloride
Pentobarbital-BAR
Phencyclidine-PCP
Phenethylamine-MAMP
Phenobarbital-BAR
Phenytoin (Diphenylhydantoin)-BAR
Phenylpropanolamine
Prednisolone
Procainamide
Promethazine
Protriptyline
Quetiapine (Seroquel)-TCA
Riboflavin
Secobarbital-BAR
Sertraline (Zoloft)
Sulindac
Temazepam glucuronide-BZO
8-Tetrahydrocannabinol
Theophyline
Thioridazine
Tolmetin (Tolectin)
Triazolam-BZO
Trimethoprim
Tryptamine
Tyrosine
Verapamil

Methylphenidate
Midazolam-BZO
Morphine-OPI, OXY
Nalidixic Acid
Naloxone-OXY
Nicotine
Nitrofurantoin
Nordiazepam-BZO
Norlysergic Acid
l-Norpseudoephedrine
Nylidrin
Olanzapine-TCA
Oxalic Acid
Oxazepam glucuronide-BZO
Oxymetazoline
Penicillin G
Perphenazine
Phendimetrazine
Pheniramine
Phenothiazine
Phenylbutazone
Piroxicam
Prednisone
Prochlorperazine-TCA
Propoxyphene-PPX
d-Pseudoephedrine
Quinidine
Rifampin
Selegiline (Deprenyl)
Sildenafil (Viagra)
Talbutal-BAR
Tetracycline
Tetrahydrozoline
Thiamine
Thiothixene
Trazodone
Triazolam, 1-hydroxy
Trimipramine-TCA
Tryptophan
Valproic Acid
Zomepirac

Non Crossreactive Endogenous Compounds
Fifteen compounds were dissolved in appropriate solvents at a concentration of at least 1.0 mg/mL. Each compound was further
diluted to 100 µg/mL except for albumin (20 mg/mL) and bilirubin (200 µg/mL). None of these compounds showed cross-reactivity at
the listed concentrations.
Acetaldehyde
Acetone
Albumin, Human
Bilirubin
Cholesterol

Creatinine
Epinephrine
-Estradiol
Estriol
Glucose Std. Solution

Hemoglobin, Human
Sodium Chloride
Tetrahydrocortisone
d,1-Thyroxine
Uric Acid

Related Compounds and Cross Reactants
The following metabolites and compounds were tested. Reference standards for the various metabolites and compounds were
prepared in negative urine samples. None of the compounds reacted with the remaining tests in the panel. Results are expressed as
the minimum concentration required to produce a positive result in the indicated assay. Compounds that reacted with the test are
listed first, and related compounds that did not react with the highest concentration tested are listed second as Negative at 100,000
ng/mL (or highest level tested).
Cannabinoids-(THC) (11-nor-9-carboxy-9-THC) 50 ng/mL
Result
Cannabidiol
Negative at 100,000 ng/mL
Cannabinol
Negative at 100,000 ng/mL
9
l-11 Hydroxy- -THC
Negative at 50,000 ng/mL
8 –Tetrahydrocannabinol
Negative at 100,000 ng/mL
9 –Tetrahydrocannabinol
Negative at 100,000 ng/mL

18

Opiates(2000)-(OPI) (Morphine) 2000 ng/mL
Result
Codeine
Positive at 800 ng/mL
Diacetylmorphine
Positive at 2,000 ng/mL
Dihydrocodeine
Positive at 3,000 ng/mL
Ethylmorphine
Positive at 400 ng/mL
Hydrocodone
Positive at 2,000 ng/mL
Hydromorphone
Positive at 3,000 ng/mL
Levorphanol
Positive at 12,500 ng/mL
6-Monoacetyl Morphine
Positive at 3,000 ng/mL
Morphine 3--D-Glucuronide
Positive at 3,000 ng/mL
Morphine 6--D-Glucuronide
Positive at 25,000 ng/mL
Norcodeine
Positive at 25,000 ng/mL
Ofloxacin
Positive at 50,000 ng/mL
Thebaine
Positive at 50,000 ng/mL
Apomorphine
Nalorphine
Naloxone
Naltrexone
Oxycodone
Oxymorphone
Procaine

Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL

Opiates(300)-(OPI) (Morphine) 300 ng/mL
Codeine
Diacetylmorphine
Dihydrocodeine
Ethylmorphine
Hydrocodone
Hydromorphone
6-Monoacetylmorphine
Morphine 3--D-Glucuronide
Morphine 6--D-Glucuronide
Nalorphine
Norcodeine
Thebaine

Result
Positive at 100 ng/mL
Positive at 200 ng/mL
Positive at 400 ng/mL
Positive at 200 ng/mL
Positive at 800 ng/mL
Positive at 800 ng/mL
Positive at 200 ng/mL
Positive at 200 ng/mL
Positive at 12,500 ng/mL
Positive at 75,000 ng/mL
Positive at 12,500 ng/mL
Positive at 12,500 ng/mL

Apomorphine
Levorphanol
Naloxone
Naltrexone
Oxycodone
Oxymorphone
Procaine

Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL

Amphetamines- (AMP) (d-Amphetamine) 1000 ng/mL
Result
l-Amphetamine
Positive at 100,000 ng/mL
MDA
Positive at 400 ng/mL
Phentermine
Positive at 10,000 ng/mL

19

Ephedrine
MDMA
MDE (MDEA)
l-Methamphetamine
d-Methamphetamine
Phenethylamine
Tyramine

Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL

Cocaine-(COC) (Benzoylecgonine) 300 ng/mL
Result
Cocaine
Positive at 800 ng/mL
Isoxsuprine
Positive at 6,000 ng/mL
Ecgonine
Ecgonine Methyl Ester

Negative at 100,000 ng/mL
Negative at 100,000 ng/mL

Phencyclidine-(PCP) (Phencyclidine) 25 ng/mL
Result
4-Hydroxyphencyclidine
Positive at 5,000 ng/mL
Tricyclic Antidepressant-(TCA) (Desipramine) 300 ng/mL
Result
Amitriptyline
Positive at 500 ng/mL
Clozapine
Positive at 2,000 ng/mL
Cyclobenzaprine
Positive at 5,000 ng/mL
Doxepin
Positive at 1,000 ng/mL
Imipramine
Positive at 200 ng/mL
Maprotiline
Positive at 500 ng/mL
Nordoxepin
Positive at 750 ng/mL
Nortriptyline
Positive at 500 ng/mL
Olanzapine
Positive at 10,000 ng/mL
Prochlorperazine
Positive at 25,000 ng/mL
Promazine
Positive at 250 ng/mL
Quetiapine (Seroquel)
Positive at 2,500 ng/mL
Trimipramine
Positive at 2,500 ng/mL
Chlorpromazine
Chlorprothixine
Clomipramine
Loxapine
Mirtazepine
Norclomipramine
Perphenazine
Phenothiazine
Protriptyline
Thiothixene

Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL

Barbiturate-(BAR) (Butalbital) 200 ng/mL
Allobarbital
Alphenal
Amobarbital
Barbital
Butabarbital
Cyclopentobarbital
Diphenylhydantoin (Phenytoin)

Result
Positive at 250 ng/mL
Positive at 100 ng/mL
Positive at 2,500 ng/mL
Positive at 2,500 ng/mL
Positive at 1,000 ng/mL
Positive at 250 ng/mL
Positive at 2,500 ng/mL

20

p-Hydroxyphenobarbital
Pentobarbital
Phenobarbital
Secobarbital
Talbutal

Positive at 500 ng/mL
Positive at 500 ng/mL
Positive at 800 ng/mL
Positive at 50 ng/mL
Positive at 75 ng/mL

Aminoglutethimide
Barbituric Acid
1,3 Dimethylbarbituric Acid
Glutethimide
Hexobarbital
Mephobarbital

Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL

Methadone-(MTD) (Methadone) 300 ng/mL
Result
Primary metabolite (EDDP)
Negative at 100,000 ng/mL
Secondary metabolite (EMDP)
Negative at 100,000 ng/mL
Benzodiazepine-(BZO) (Nordiazepam) 300 ng/mL
Result
Alprazolam
Positive at 100 ng/mL
Alprazolam, 1-OH
Positive at 2,500 ng/mL
Clobazam
Positive at 50 ng/mL
Clonazepam
Positive at 250 ng/mL
Clorazepate
Positive at 250 ng/mL
Desalkylflurazepam
Positive at 250 ng/mL
Desmethylchlordiazepoxide
Positive at 500 ng/mL
Desmethylflunitrazepam
Positive at 75 ng/mL
Diazepam
Positive at 100 ng/mL
Flunitrazepam
Positive at 75 ng/mL
Lorazepam
Positive at 750 ng/mL
Lorazepam glucuronide
Positive at 250 ng/mL
Midazolam
Positive at 5,000 ng/mL
Nitrazepam
Positive at 50 ng/mL
Oxazepam
Positive at 250 ng/mL
Oxazepam glucuronide
Positive at 500 ng/mL
Temazepam
Positive at 50 ng/mL
Temazepam glucuronide
Positive at 250 ng/mL
Triazolam
Positive at 750 ng/mL
7-Aminoclonazepam
7-Aminoflunitrazepam
Chlordiazepoxide
Flurazepam
Triazolam, 1-OH

Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL

Propoxyphene-(PPX) (Norpropoxyphene) 300 ng/mL
Result
Propoxyphene
Positive at 50 ng/mL
Promethazine

Negative at 100,000 ng/mL

21

Methamphetamine-(MAMP) (d-Methamphetamine) 1000 ng/mL,
(MDMA) 1500 ng/mL
Result
Ephedrine
Positive at 2,500 ng/mL
Fenfluramine
Positive at 25,000 ng/mL
MDE (MDEA)
Positive at 5,000 ng/mL
l-Methamphetamine
Positive at 7,500 ng/mL
Phenethylamine
Positive at 2,500 ng/mL
Phenylephrine
Positive at 50,000 ng/mL
Procaine
Positive at 10,000 ng/mL
d-Amphetamine
l-Amphetamine
MDA
Phentermine
Pseudoephedrine
Tyramine

Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL

Oxycodone (OXY) 100 ng/mL
Codeine
Dihydrocodeine
Ethylmorphine
Hydrocodone
Hydromorphone
Morphine
Naloxone
Naltrexone
Norcodeine
Oxymorphone

Result
Positive at 2,500 ng/mL
Positive at 2,500 ng/mL
Positive at 2,500 ng/mL
Positive at 10,000 ng/mL
Positive at 10,000 ng/mL
Positive at 5,000 ng/mL
Positive at 10,000 ng/mL
Positive at 25,000 ng/mL
Positive at 50,000 ng/mL
Positive at 200 ng/mL

Apomorphine
Diacetylmorphine
Levorphanol
6-Monoacetylmorphine
Morphine 3-β-D-Glucuronide
Morphine 6-β-D-Glucuronide
Nalorphine
Thebaine

Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 50,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL
Negative at 10,000 ng/mL
Negative at 100,000 ng/mL
Negative at 100,000 ng/mL

Interference-Oxycodone
pH and Specific Gravity:
The MEDTOX® OXYCODONE test was assayed with six negative clinical samples with pH values of 4.0, 5.0, 6.0, 7.0, 8.0 and 9.0 ±
0.1. Each sample was assayed in triplicate. The pH samples were fortified with Oxycodone to the concentrations of 25 ng/mL and 150
ng/mL. All the pH levels gave negative results when fortified to 25 ng/mL, and all pH levels gave positive results when fortified to
150 ng/mL.
The MEDTOX® OXYCODONE test was assayed with eight samples with specific gravity values of 1.003, 1.005, 1.010, 1.015, 1.020,
1.025, 1.030 and 1.035 ± 0.001. Each sample was assayed in triplicate. The specific gravity samples were fortified with Oxycodone to
the concentrations of 25 ng/mL and 150 ng/mL. All the specific gravity levels gave negative results when fortified to 25 ng/mL, and
all specific gravity levels gave positive results when fortified to 150 ng/mL.

22

Common Drugs:
Following the study of M.L. Smith, et. al.5 drug free urine samples were spiked with Oxycodone to the concentrations of 25 ng/mL
and 150 ng/mL. 100 µg/mL of the common drugs were then added to the preparation and assayed by the MEDTOX ® OXYCODONE
test. Samples were evaluated in triplicate by in-house operators. None of the common drugs listed in the following table affected the
expected results.
COMMON DRUGS EVALUATED WITH MEDTOX® OXYCODONE TESTS
Acetylsalicylic Acid
Chlorpheniramine
Ibuprofen
Acetaminophen
Cocaine
Morphine-OXY
Brompheniramine maleate
Dextromethorphan
Phenobarbital
Caffeine
Diphenylhydantoin
d-Pseudoephedrine
Carbamazepine
Doxylamine
Salicylic Acid

Interference Propoxyphene/Methamphetamine Only
Following the study of M.L Smith, et. al.5 the following drugs were tested to determine the degree of interference they may have on
the test. Commercial negative urine was spiked with 100 µg/mL of each of these drugs and with either 75 ng/mL or 600 ng/mL of
norpropoxyphene or methamphetamine. Each spiked sample was tested in triplicate on the test. None of these drugs affected the
expected negative or positive results with either the 75 ng/mL or 600 ng/mL fortified samples. The drugs are listed below.
Acetylsalicylic Acid
Acetaminophen
Brompheniramine maleate
Caffeine
Carbamazepine

Chlorpheniramine
Cocaine
Dextromethorphan
5,5 Diphenylhydantoin
Doxylamine

Ibuprofen
Morphine
Phenobarbital
d-Pseudoephedrine
Salicyclic Acid

15. BIBLIOGRAPHY
1.
2.
3.
4.
5.

6.

Blum, K. Handbook of Abusable Drugs. Gardener Press, Inc. New York, New York, 1984. pp. 305-349.
DeCresce, R.P., Lifshitz, M.S., Mazura, A.C. and Tilson, J.E. Drug Testing in the Workplace. ASCP Press. American Society of
Clinical Pathologists. Chicago, Illinois. 1989. pp. 105-109.
Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man. Eighth Edition. Biomedical Publications. Foster City, California,
2008.
White, R.M. and Black, M.L. Pain Management Testing Reference. AACC Press. Washington, DC. 2007.
Smith, M.L., Shimomura, E.T., Summers, J., Paul, B.D., Nichols, D., Shippee, R., Jenkins, A.J., Darwin, W.D., and Cone, E.J.
Dectection Times and Analytical Performance of Commercial Urine Opiate Immunoassays Following Heroin Administration,
Journal of Analytical Toxicology. Volume 24:7. October 2000, pages 522-529.
Cary, P.L. The Marijuana Detection Window: Determining the Length of Time Cannabinoids will Remain Detectable in Urine
Following Smoking: A Critical Review of Relevant Research and Cannabinoid Detection Guidance for Drug Courts, Drug Court
Review. Volume V:1. 2005, pp. 23 – 58.

16. LIMITED EXPRESS WARRANTIES
The manufacturer makes no express warranty other than the diagnostic test kit will measure certain drugs and/or drug metabolites
when used in accordance with the manufacturer‟s printed instructions. The use of the kit for any other purpose is outside the intended
use of this product. The manufacturer gives no express warranty as to what the legal or clinical significance is of the levels of
drug(s)/drug metabolites detected by the PROFILE-II/VERDICT-II Drugs of Abuse Test. The manufacturer disclaims any and all
implied warranties of merchantability, fitness for use or implied utility for any other purposes. Any and all damages for failure of
the kit to perform to its instructions are limited to the replacement value of the kit.
Covered by one or more patents.
U.S. Patent Nos. 6,566,051, 6,376,251, 6,653,139
This product does not contain controlled substances.

23

This product does not contain hazardous or toxic chemicals as defined by the OSHA Hazard Communication Rule [29 CFR
1910.1200(g)].
MEDTOX Diagnostics Inc.
1238 Anthony Road
Burlington, NC 27215
To place an order or for technical services call 1-800-832-3244.
© 2011 MEDTOX Diagnostics, Inc. All rights reserved

P/N 101505
Rev. 6/11
Printed in USA

24



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