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Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
PROFESSIONAL MEDICAL PRODUCTS
TEST MULTIDROGHE ONE STEP (URINA)
ONE STEP SCREEN TEST PANEL (URINE)
ESSAI MULTI-DROGUE ONE STEP (URINE)
MULTI-DROGEN-TEST ONE STEP (URIN)
PRUEBA DE MULTIDROGAS EN UN SOLO PASO (ORINA)
TESTE TOXICOGÓGICO ONE STEP (URINA)
ΕΞΕΤΑΣΗ ΠΟΛΛΑΠΛΏΝ ΦΑΡΜΑΚΏΝ ΕΝΟΣ ΣΤΑΔΊΟΥ (ΟΥΡΑ)
Manuale d’uso - User manual
Manuel de l’utilisateur - Guía de uso
Guia para utilização
Gebrauchs- und instandhaltungsanleitung
Οδηγίες χρήσης -
PER USO PROFESSIONALE
FÜR DEN PROFESSIONELLEN GEBRAUCH
FOR PROFESSIONAL USE
PARA USO PROFESIONAL
PARA USO PROFISSIONAL
ΓΙΑ ΕΠΑΓΓΕΛΜΑΤΙΚΗ ΧΡΗΣΗ
ATTENZIONE: Gli operatori devono leggere e capire completamente questo manuale prima di utilizzare il prodotto.
ATTENTION: The operators must carefully read and completely understand the present manual
before using the product.
AVIS: Les opérateurs doivent lire et bien comprendre ce manuel avant d’utiliser le produit.
ACHTUNG: Diese Anleitung muss vor dem Einsatz des Produkts aufmerksam gelesen und vollständig
verstanden werden.
ATENCIÓN: Los operadores tienen que leer y entender completamente este manual antes de utilizar el producto.
ATENÇÃO: Os operadores devem ler e entender completamente este manual antes de usar o produto.
ΠΡΟΣΟΧΗ: Οι χειριστές αυτού του προϊόντος πρέπει να διαβάσουν και να καταλάβουν πλήρως
τις οδηγίες του εγχειριδίου πριν από την χρήση του.
24549 - 24550 - 24551
30°C
2°C
Gima S.p.A.
Via Marconi, 1
20060 Gessate (MI) Italy
Made in China (P.R.C.)
M-24550-M-Rev.5-06.18
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ENGLISH
10
One Step Screen Test Panel (Urine)
Package insert for testing of any combination of the following drugs:
Amphetamine 300, Amphetamine 500, Amphetamine, Barbiturates, Benzodiazepines 200, Benzodiazepines,
Buprenorphine, Clonazepam, Cocaine 150, Cocaine, Cotinine, Fentanyl, Heroin (6-acetylmorphine), Ketamine, Marijuana
20, Marijuana, Marijuana 150, Methadone, EDDP 100 (Methadone metabolite), EDDP 300 (Methadone metabolite),
Methamphetamine 300, Methamphetamine 500, Methamphetamine, Methylenedioxymethamphetamine, Morphine 300,
Opiate 2000, Oxycodone, Phencyclidine, Propoxyphene, Tramadol and Tricyclic Antidepressants.
Including Specimen Validity Tests (S.V.T.) for Oxidants/Pyridinium Chlorochromate (OX/PCC), Specic Gravity (S.G.),
pH, Nitrite (NIT), Glutaraldehyde (GLUT) and Creatinine (CRE).
A rapid, one step screen test for the simultaneous, qualitative detection of multiple drugs and metabolites in human
urine. For medical and other professional in vitro diagnostic use only.
INTENDED USE & SUMMARY
Urine based screen tests for multiple drugs of abuse range from simple immunoassay tests to complex analytical
procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method to screen
urine for multiple drugs of abuse.
The Multi-Drug One Step Screen Test Panel (Urine) is a lateral ow chromatographic immunoassay for the qualitative
detection of following drugs without the need of instruments.
Test Calibrator Cut-o
Amphetamine (AMP 300) d-Amphetamine 300
Amphetamine (AMP 500) d-Amphetamine 500
Amphetamine (AMP) d-Amphetamine 1 000
Barbiturates (BAR) Secobarbital 300
Benzodiazepines (BZO 200) Oxazepam 200
Benzodiazepines (BZO) Oxazepam 300
Buprenorphine (BUP) Buprenorphine 10
Clonazepam (ACL) 7-Aminoclonazepam 100
Cocaine (COC 150) Benzoylecgonine 150
Cocaine (COC) Benzoylecgonine 300
Cotinine (COT) Cotinine 100
Fentanyl (FTY) Norfentanyl 20
Heroin (HRN) 6-Acetylmorphine 10
Ketamine (KET) Ketamine 1 000
Marijuana (THC 20) 11-nor-Δ
Marijuana (THC) 11-nor-Δ
Marijuana (THC 150) 11-nor-Δ
Methadone (MTD) Methadone 300
Methadone metabolite (EDDP 100) 2-Ethylidene-1,5-dimethyl-3,3-dipheylpyrrolidine (EDDP) 100
Methadone metabolite (EDDP 300) 2-Ethylidene-1,5-dimethyl-3,3-dipheylpyrrolidine (EDDP) 300
Methamphetamine (MET 300) d-Methamphetamine 300
Methamphetamine (MET 500) d-Methamphetamine 500
Methamphetamine (MET) d-Methamphetamine 1 000
Methylenedioxymethamphetamine (MDMA) d,l-Methylenedioxymethamphetamine 500
Morphine (MOP 300) Morphine 300
Opiate (OPI 2000) Morphine 2 000
Oxycodone (OXY) Oxycodone 100
Phencyclidine (PCP) Phencyclidine 25
Propoxyphene (PPX) Propoxyphene 300
Tramadol (TRA) Tramadol 100
Tricyclic Antidepressants (TCA) Nortriptyline 1 000
1
(ng/mL)
9
-THC-9 COOH 20
9
-THC-9 COOH 50
9
-THC-9 COOH 150
This test will detect other related compounds, please refer to the Analytical Specicity table in this package insert.
Congurations of the Multi-Drug One Step Screen Test Panel (Urine) come with any combination of the above
listed drug analytes with or without S.V.T. This assay provides only a preliminary analytical test result. A
more specic alternate chemical method must be used in order to obtain a conrmed analytical result. Gas
chromatography/mass spectrometry (GC/MS) is the preferred conrmatory method. Clinical consideration
and professional judgment should be applied to any drug of abuse test result, particularly when preliminary
positive results are indicated.
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S.V.T. SUMMARY
Each S.V.T. strip contains chemically treated reagent pads. Three to ve minutes following the activation of the reagent
pads by the urine sample, the colors that appear on the pads can be compared with the printed color chart card. The
color comparison provides a semi-quantitative screen for any combination of oxidants/pyridinium chlorochromate
(PCC), specic gravity, pH, nitrite, glutaraldehyde and creatinine in human urine which can help assess the integrity
of the urine sample.
PRINCIPLE
The Multi-Drug One Step Screen Test Panel (Urine) is an immunoassay based on the principle of competitive binding.
Drugs which may be present in the urine specimen compete against their respective drug conjugate for binding sites
on their specic antibody.
During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below
its cut-o concentration, will not saturate the binding sites of its specic antibody coated on the particles. The antibody
coated particles will then be captured by the immobilized drug conjugate and a visible colored line will show up in the
test line region of the specic drug strip. The colored line will not form in the test line region if the drug level is above its
cut-o concentration because it will saturate all the binding sites of the antibody coated on the particles.
A drug-positive urine specimen will not generate a colored line in the specic test line region of the strip because of
drug competition, while a drug-negative urine specimen or a specimen containing a drug concentration less than the
cut-o will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at
the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
S.V.T. PRINCIPLE
Adulteration is the tampering of a urine specimen with the intention of altering the test results.
The use of adulterants can cause false negative results in drug tests by either interfering with the screening test and/
or destroying the drugs present in the urine. Dilution may also be employed in an attempt to produce false negative
drug test results.
One of the best ways to test for adulteration or dilution is to determine certain urinary characteristics such as pH and
specic gravity and to detect the presence of oxidants/PCC, specic gravity, pH, nitrite, glutaraldehyde and creatinine
in urine.
• Oxidants/PCC (Pyridinium chlorochromate) tests for the presence of oxidizing agents such as bleach and hydrogen
peroxide. Pyridinium Chlorochromate is a commonly used adulterant.2 Normal human urine should not contain oxidants
or PCC.
• Specic gravity tests for sample dilution. The normal range is from 1.003 to 1.030. Values outside this range may be
the result of specimen dilution or adulteration.
• pH tests for the presence of acidic or alkaline adulterants in urine. Normal pH levels should be in the range of 4.0 to
9.0. Values outside of this range may indicate the sample has been altered.
• Nitrite tests for commonly used commercial adulterants such as Klear or Whizzies. They work by oxidizing the major
cannabinoid metabolite THC-COOH.
3
Normal urine should contain no trace of nitrite. Positive results generally indicate
the presence of an adulterant.
• Glutaraldehyde tests for the presence of an aldehyde. Adulterants such as UrinAid and Clear Choice contain
glutaraldehyde which may cause false negative screening results by disrupting the enzyme used in some immunoassay
tests.2 Glutaraldehyde is not normally found in urine; therefore, detection of glutaraldehyde in a urine specimen is
generally an indicator of adulteration.
• Creatinine is a waste product of creatine, an amino acid contained in muscle tissue and found in urine.
1
A person
may attempt to foil a test by drinking excessive amounts of water or diuretics such as herbal teas to “ush” the system.
Creatinine and specic gravity are two ways to check for dilution and ushing, which are the most common mechanisms
used in an attempt to circumvent drug testing. Low creatinine and specic gravity levels may indicate dilute urine. The
absence of creatinine (< 5 mg/dL) is indicative of a specimen not consistent with human urine.
REAGENTS
Each test contains specic drug antibody-coupled particles and corresponding drug-protein conjugates. A goat antibody
is employed in each control line.
S.V.T. REAGENTS
Oxidants/PCC 0.36% 99.64%
Specic Gravity 0.25% 99.75%
pH 0.06% 99.94%
Nitrite 0.07% 99.93%
Glutaraldehyde 0.02% 99.98%
Creatinine 0.04% 99.96%
Adulteration Pad Reactive indicator Buers and non-reactive ingredients
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PRECAUTIONS
• For medical and other professional in vitro diagnostic use only. Do not use after the expiration date.
• The test panel should remain in the sealed pouch until use.
• All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
• The used test panel should be discarded according to local regulations.
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test panel is stable
through the expiration date printed on the sealed pouch. The test panel must remain in the sealed pouch until use. DO
NOT FREEZE. Do not use beyond the expiration date.
SPECIMEN COLLECTION AND PREPARATION
Urine Assay
The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used.
Urine specimens exhibiting visible precipitates should be centrifuged, ltered, or allowed to settle to obtain a clear
supernatant for testing.
Specimen Storage
Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens may
be frozen and stored below -20°C. Frozen specimens should be thawed and mixed well before testing. When tests
include S.V.T., storage of urine specimens should not exceed 2 hours at room temperature or 4 hours refrigerated prior
to testing. For best results, test specimens immediately following collection.
MATERIALS
Materials Provided
• Test panels • SVT/Adulterant color chart (if applicable) • Package insert
Materials Required But Not Provided
• Specimen collection container • Timer
DIRECTIONS FOR USE
Allow the test panel, urine specimen,
and/or controls to equilibrate to room
temperature (15-30°C) prior to testing.
1. Remove the test card from the sealed
pouch and use it as soon as possible.
Remove the cap from the end of the test
card. With arrows pointing toward the
urine specimen, immerse the strip(s)
of the test card vertically in the urine
specimen for at least 10-15 seconds.
Immerse the strip(s) to at least the
level of the wavy lines, but not above
the arrow(s) on the test card.
2. Replace the cap and place the test
card on a non-absorbent at surface,
start the timer and wait for the colored
line(s) to appear.
3. Read the adulteration strip between 3
and 5 minutes by comparing the colors
on the adulteration strip to the enclosed
color chart. If the result indicates adulteration, do not interpret the drug test results. Either retest the urine or collect
another specimen.
4. Read the drug strip results at 5 minutes. Do not read results after 10 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* A colored line in the control line region (C) and a colored line in the test line region (T) for a specic
drug indicate a negative result. This indicates that the drug concentration in the urine specimen is below the designated
cut-o level for that specic drug.
*NOTE: The shade of color in the test region (T) may vary, but it should be considered negative whenever there is
even a faint colored line.
POSITIVE: A colored line in the control line region (C) but no line in the test line region (T) for a specic drug
indicates a positive result. This indicates that the drug concentration in the urine specimen exceeds the designated
cut-o for that specic drug.
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INVALID: Control line fails to appear. Insucient specimen volume or incorrect procedural techniques are the most
likely reasons for control line failure. Review the procedure and repeat the test using a new test panel. If the problem
persists, discontinue using the lot immediately and contact your local distributor.
SVT/ADULTERANT INTERPRETATION
(Please refer to the color chart)
Semi-quantitative results are obtained by visually comparing the reacted color blocks on the strips to the printed color
blocks on the color chart. No instrumentation is required.
QUALITY CONTROL
A procedural control is included in the test. A colored line appearing in the control line region (C) is considered an internal
procedural control. It conrms sucient specimen volume, adequate membrane wicking and correct procedural technique.
Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested
as good laboratory practice to conrm the test procedure and to verify proper test performance.
LIMITATIONS
1. The Multi-Drug One Step Screen Test Panel (Urine) provides only a preliminary analytical result. A more specic
chemical method must be used to obtain a conrmed result. Gas chromatography/mass spectrometry (GC/MS) is the
preferred conrmatory method.
4, 5
2. It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen may
cause erroneous results.
3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical
method used. If adulteration is suspected, the test should be repeated with another urine specimen.
4. A positive result indicates presence of the drug or its metabolites but does not indicate level of intoxication, administration
route or concentration in urine.
5. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present
but below the cut-o level of the test.
6. The test does not distinguish between drugs of abuse and certain medications.
7. A positive result might be obtained from certain foods or food supplements.
S.V.T. ADULTERATION LIMITATIONS
1. The adulteration tests included with this product are meant to aid in the determination of abnormal specimens. While
comprehensive, these tests are not meant to be an “all-inclusive” representation of possible adulterants.
2. Oxidants/PCC: Normal human urine should not contain oxidants or PCC. The presence of high levels of antioxidants
in the specimen, such as ascorbic acid, may result in false negative results for the oxidants/PCC pad.
3. Specic Gravity: Elevated levels of protein in urine may cause abnormally high specic gravity values.
4. Nitrite: Nitrite is not a normal component of human urine. However, nitrite found in urine may indicate urinary tract
infections or bacterial infections. Nitrite levels of > 20 mg/dL may produce false positive glutaraldehyde results.
5. Glutaraldehyde: Is not normally found in urine. However certain metabolic abnormalities such as ketoacidosis (fasting,
uncontrolled diabetes or high-protein diets) may interfere with the test results.
6. Creatinine: Normal creatinine levels are between 20 and 350 mg/dL. Under rare conditions, certain kidney diseases
may show dilute urine.
PERFORMANCE CHARACTERISTICS
Accuracy
A side-by-side comparison was conducted using the Multi-Drug One Step Screen Test Panel (Urine) and commercially
available drug rapid tests. Testing was performed on approximately 300 specimens previously collected from subjects
present for drug screen testing. Presumptive positive results were conrmed by GC/MS. The following results were tabulated:
% Agreement with Commercial Kit
Specimen AMP
Positive >99% * 97% >99% * 90% 88% * >99% 95% >99% * * * * 98%
Negative >99% * >99% 99% * 97% >99% * >99% >99% >99% * * * * >99%
Total >99% * 98% 99% * 94% 97% * >99% 98% >99% * * * * 99%
Specimen THC
Positive * >99% * * * >99% 98% >99% >99% 99% 96% 98% >99% * 95%
Negative * >99% * * * 80% >99% 99% >99% >99% 99% >99% >99% * >99%
Total * >99% * * * 87% 99% 99% >99% >99% 98% >99% >99% * 99%
300
150
AMP
AMP BAR BZO
500
MTD EDDP
100
EDDP
300
BZO BUP** ACL COC
200
MET
MET
300
MET MDMA MOP
500
COC COT FTY KET HRN THC 20THC
150
OPI
300
OXY PCP PPX TRA TCA
2000
* NOTE: Commercial kit unavailable for comparison testing.
** NOTE: BUP was compared to the self-reported use of Buprenorphine.
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% Agreement with GC/MS
Specimen AMP
Positive >99% 98% 97% 92% 98% 97% 98% >99% 99% 96% >99% 99% 99% >99% 87% 96%
Negative 99% >99% 95% 98% 99% 95% >99% >99% >99% 90% >99% 90% >99% 95% 99% 97%
Total 99% >99% 96% 95% 99% 96% >99% >99% 99% 93% >99% 93% >99% 95% 95% 96%
Specimen THC
Positive 91% 99% 98% >99% 97% >99% 99% >99% >99% 98% 98% >99% 94% 99% >99%
Negative 96% 94% >99% 94% >99% 96% 94% 98% 94% 97% 99% 96% 99% 96% 89%
Total 96% 96% 99% 96% 98% 98% 96% 99% 97% 98% 99% 97% 96% 97% 91%
* NOTE: BUP, COT, FTY and TRA were based on LC/MS data instead of GC/MS.
** NOTE: TCA was based on HPLC data instead of GC/MS.
Analytical Sensitivity
A drug-free urine pool was spiked with drugs to the concentrations at ± 50% cut-o and ± 25%
cut-o. The results are summarized below.
Drug Conc.
(Cut-o range)
0% Cut-o 30 0 30 0 30 0 30 0 60 0 30 0 90 0 90 0 30 0 30 0 90 0
-50% Cut-o 30 0 30 0 30 0 30 0 60 0 30 0 90 0 90 0 30 0 30 0 90 0
-25% Cut-o 27 3 30 0 22 8 27 3 60 0 27 3 75 15 82 8 24 6 30 0 90 0
Cut-o 13 17 24 6 12 18 22 8 22 38 11 19 60 30 39 51 14 16 4 26 46 44
+25% Cut-o 4 26 0 30 2 28 8 22 2 58 5 25 31 59 0 90 7 23 0 30 5 85
+50% Cut-o 0 30 0 30 0 30 2 28 0 60 0 30 0 90 0 90 0 30 0 30 0 90
Drug Conc.
(Cut-o range)
0% Cut-o 90 0 90 0 90 0 30 0 30 0 90 0 30 0 90 0 90 0 30 0 30 0
-50% Cut-o 90 0 90 0 90 0 30 0 30 0 90 0 29 1 90 0 90 0 30 0 30 0
-25% Cut-o 85 5 N/A N/A 90 0 27 3 12 18 90 0 24 6 90 0 90 0 27 3 23 7
Cut-o 49 41 N/A N/A 57 33 24 6 1 29 46 44 21 9 37 53 51 39 15 15 13 17
+25% Cut-o 13 77 N/A N/A 3 87 17 13 1 29 5 85 2 28 8 82 14 76 4 26 8 22
+50% Cut-o 0 90 0 90 0 90 5 25 0 30 0 90 0 30 0 90 0 90 0 30 0 30
Drug Conc.
(Cut-o range)
0% Cut-o 30 0 30 0 30 0 30 0 30 0 30 0 30 0 30 0 90 0
-50% Cut-o 30 0 30 0 30 0 30 0 30 0 30 0 30 0 30 0 90 0
-25% Cut-o 30 0 26 4 25 5 25 5 30 0 19 11 24 6 29 1 90 0
Cut-o 18 12 17 13 17 13 15 15 18 12 16 14 17 13 18 12 61 29
+25% Cut-o 1 29 4 26 1 29 6 24 6 24 6 24 7 23 5 25 21 69
+50% Cut-o 0 30 0 30 0 30 0 30 0 30 0 30 0 30 0 30 2 88
AMP
300
150
AMP BAR BZO
500
MTD EDDP
AMP
300
- + - + - + - + - + - + - + - + - + - + - +
FTY HRN KET THC 20 THC THC 150 MTD EDDP
- + - + - + - + - + - + - + - + - + - + - +
MET MDMA MOP
- + - + - + - + - + - + - + - + - +
100
AMP
500
EDDP
300
BZO BUP* ACL COC
200
MET
MET
300
AMP BAR BZO 200 BZO BUP ACL COC
300
MET MDMA MOP
500
OPI
OXY PCP PPX TCA TRA
2000
COC COT* FTY* HRN KET THC 20THC
150
OPI
300
OXY PCP PPX TRA* TCA**
2000
150
EDDP
100
300
COC COT
MET 300 MET 500
14
Analytical Specicity
The following tables lists the concentration of compounds (ng/mL) that are detected positive in urine by the Multi-Drug
One Step Screen Test Panel (Urine) at 5 minutes.
AMPHETAMINE 300
d-Amphetamine 300
d,l-Amphetamine 390
l-Amphetamine 50 000
p-Hydroxyamphetamine 1 560
p-Hydroxynorephedrine 100 000
3,4-Methylenedioxyamphetamine
(MDA)
β-Phenylethylamine 100 000
Phenylpropanolamine (d,l-
Norephedrine)
Tyramine 100 000
1 560
100 000
AMPHETAMINE 500
d-Amphetamine 500
d,l-Amphetamine 1 500
l-Amphetamine 50 000
p-Hydroxyamphetamine 190
3,4-Methylenedioxyamphetamine
(MDA)
Phentermine 1 500
AMPHETAMINE
d-Amphetamine 1 000
d,l-Amphetamine 3 000
l-Amphetamine 50 000
781
d,l-3,4-Methylenedioxyamphetamine (MDA)
Phentermine 3 000
BARBITURATES
Secobarbital 300
Alphenal 150
Amobarbital 300
Aprobarbital 200
Butabarbital 75
Butalbital 2 500
Butethal 100
Cyclopentobarbital 600
2 000
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Pentobarbital 300
Phenobarbital 100
BENZODIAZEPINES 200
Oxazepam 200
Alprazolam 30
7-Aminoclonazepam 4 000
7-Aminounitrazepam 390
7-Aminonitrazepam 625
Bromazepam 390
Chlordiazepoxide 300
Clobazam 48
Clorazepate 97
Desalkylurazepam 1 560
Diazepam 97
Estazolam 125
Flunitrazepam 25 000
α-Hydroxyalprazolam 30
d-Lorazepam 3 125
Midazolam 195
Nitrazepam 780
Norchlordiazepoxide 780
Nordiazepam 780
Temazepam 33
Triazolam 150
BENZODIAZEPINES
Oxazepam 300
Alprazolam 196
Bromazepam 1 562
Chlordiazepoxide 1 562
Clobazam 98
Clonazepam 781
Clorazepate 195
Delorazepam 1 562
Desalkylurazepam 390
Diazepam 195
Estazolam 2 500
Flunitrazepam 390
α-Hydroxyalprazolam 1 262
d,l-Lorazepam 1 562
RS-Lorazepam glucuronide 156
Midazolam 12 500
Nitrazepam 98
Norchlordiazepoxide 195
Nordiazepam 390
Temazepam 98
Triazolam 2 500
BUPRENORPHINE
Buprenorphine 10
Buprenorphine 3-D-glucuronide 15
Norbuprenorphine 20
Norbuprenorphine
3-D-glucuronide
200
CLONAZEPAM
7-Aminoclonazepam 100
Alprazolam 6
7-Aminounitrazepam 6
7-Aminonitrazepam 5
Bromazepam 6
Chlordiazepoxide 24
Clobazam 6
Clonazepam 49
Clorazepate 50
Delorazepam 100
Desalkylurazepam 12
Diazepam 25
Estazolam 2
Flunitrazepam 100
α-Hydroxyalprazolam 5
α-Hydroxymidazolam 10
α-Hydroxytriazolam 1
d,l-Lorazepam 400
Lorazepam glucuronide 10 000
Midazolam 200
Nitrazepam 12
Norchlordiazepoxide 50
Nordiazepam 6
Oxazepam 98
Oxazepam glucuronide 10 000
Temazepam 12
Temazepam glucuronide 5 000
Triazolam 24
COCAINE 150
Benzoylecgonine 150
Cocaethylene 6 250
Cocaine 400
Ecgonine 12 500
Ecgonine methylester 50 000
COCAINE
Benzoylecgonine 300
Cocaethylene 12 500
Cocaine 780
Ecgonine 32 000
COTININE
l-Cotinine 100
S-l-Nicotine 12 500
FENTANYL
Norfentanyl 20
Alfentanyl 562 500
Buspirone 12 500
Fenuramine 37 500
Fentanyl 100
Sufentanyl 57 500
Risperidone 1 000
9-hydroxyrisperidone 1 000
HEROIN
6-Acetylmorphine 10
6-Acetylcodeine 1 562
Heroin 10
Morphine 500 000
KETAMINE
Ketamine 1 000
Norketamine 50 000
Pentobarbital 50 000
Secobarbital 100 000
MARIJUANA 20
8
11-nor-Δ
-THC-9 COOH 20
9
11-nor-Δ
-THC-9 COOH 20
Cannabinol 12 500
8
Δ
− THC 10 000
9
Δ
− THC 12 500
MARIJUANA
9
11-nor-Δ
-THC-9 COOH 50
8
11-nor-Δ
-THC-9 COOH 30
Cannabinol 20 000
8
Δ
− THC 15 000
9
Δ
− THC 15 000
MARIJUANA 150
9
11-nor-Δ
-THC-9 COOH 150
8
11-nor-Δ
-THC-9 COOH 500
Cannabinol 25 000
8
Δ
− THC 25 000
9
Δ
− THC 25 000
METHADONE
Methadone 300
Doxylamine 50 000
EDDP 100
2-Ethylidene-1,5-dimethyl-3,3-
diphenylpyrrolidine (EDDP)
100
EDDP 300
2-Ethylidene-1,5-dimethyl-3,3-
diphenylpyrrolidine (EDDP)
300
METHAMPHETAMINE 300
d-Methamphetamine 300
d,l-Amphetamine 100 000
Chloroquine 25 000
Ephedrine 100 000
(1R,2S)-l-Ephedrine 100 000
l-Epinephrine 50 000
Fenuramine 12 500
p-Hydroxymethamphetamine 25 000
Mephentermine 50 000
l-Methamphetamine 3 125
3,4-Methylenedioxymetham-
phetamine (MDMA)
780
Trimethobenzamide 25 000
METHAMPHETAMINE 500
d-Methamphetamine 500
d,l-Amphetamine 75 000
d-Amphetamine 50 000
Chloroquine 12 500
(1R,2S)-l-Ephedrine 50 000
p-Hydroxymethamphetamine 15 000
Mephentermine 25 000
l-Methamphetamine 4 000
3,4-Methylenedioxymetham-
phetamine (MDMA)
1 000
l-Phenylephrine 100 000
β-Phenylethylamine 75 000
METHAMPHETAMINE
d-Methamphetamine 1 000
p-Hydroxymethamphetamine 30 000
Mephentermine 50 000
l-Methamphetamine 8 000
d,l-3,4-Methylenedioxy-
methamphetamine (MDMA)
METHYLENEDIOXYMETHAMPHETAMINE
(MDMA)
d,l-3,4-Methylenedioxy-
methamphetamine (MDMA)
d,l-3,4-Methylenedioxy-
amphetamine (MDA)
3,4-Methylenedioxyethylampheta-
mine (MDEA)
2 000
500
3 000
300
MORPHINE 300
Morphine 300
Codeine 300
Ethylmorphine 6 250
Hydrocodone 50 000
Hydromorphone 3 125
Levorphanol 1 500
Page 8
ENGLISH
16
6-Acetylmorphine 400
Morphine 3-β-D-glucuronide 1 000
Norcodeine 6 250
Normorphine 100 000
Oxycodone 30 000
Oxymorphone 100 000
Procaine 15 000
Thebaine 6 250
OPIATE 2000
Morphine 2 000
Codeine 2 000
Ethylmorphine 5 000
Hydrocodone 12 500
Hydromorphone 5 000
Levorphanol 75 000
6-Acetylmorphine 5 000
Morphine 3-β-D-glucuronide 2 000
Norcodeine 12 500
Normorphine 50 000
Oxycodone 25 000
Oxymorphone 25 000
Procaine 150 000
Thebaine 100 000
OXYCODONE
Oxycodone 100
Hydrocodone 6 250
Hydromorphone 50 000
Levorphanol 50 000
Naloxone 37 500
Naltrexone 37 500
Oxymorphone 200
PHENCYCLIDINE
Phencyclidine 25
4-Hydroxyphencyclidine 12 500
PROPOXYPHENE
d-Propoxyphene 300
d-Norpropoxyphene 300
TRAMADOL
Cis-tramadol 100
d,l-O-Desmethyl venlafaxine 25 000
n-Desmethyl-cis-tramadol 195
o-Desmethyl-cis-tramadol 6 250
Phencyclidine 100 000
Procyclidine 100 000
TRICYCLIC ANTIDEPRESSANTS
Nortriptyline 1 000
Amitriptyline 1 500
Clomipramine 12 500
Desipramine 200
Doxepin 2 000
Imipramine 400
Maprotiline 2 000
Nordoxepin 1 000
Promazine 1 500
Promethazine 25 000
Trimipramine 3 000
Cross-Reactivity
A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free urine or
Amphetamine 300, Amphetamine 500, Amphetamine, Barbiturates, Benzodiazepines 200, Benzodiazepines,
Buprenorphine, Clonazepam, Cocaine 150, Cocaine, Cotinine, Fentanyl, Heroin (6-acetylmorphine), Ketamine, Marijuana
20, Marijuana, Marijuana 150, Methadone, EDDP 100 (Methadone metabolite), EDDP 300 (Methadone metabolite),
Methamphetamine 300, Methamphetamine 500, Methamphetamine, Methylenedioxymethamphetamine, Morphine 300,
Opiate 2000, Oxycodone, Phencyclidine, Propoxyphene, Tramadol and Tricyclic Antidepressants positive urine. The
following compounds show no cross-reactivity when tested with the Multi-Drug One Step Screen Test Panel (Urine) at
a concentration of 100 μg/mL.
Non Cross-Reacting Compounds
4-Acetamidophenol Diclofenac Labetalol Prednisolone
Acetone Dicyclomine Lidocaine Prednisone
Acetophenetidin Diunisal Lindane d,l-Propanolol
Acetylsalicylic acid Digoxin Lithium Quinacrine
Albumin 4-Dimethylaminoantipyrine Loperamide Quinidine
alpha-Naphthaleneacetic Acid Diphenhydramine l-Thyroxine Quinine
Aminopyrine 5,5-Diphenylhydantoin Meperidine R(-) Deprenyl
Amoxapine EMDP Meprobamate Riboavin
Amoxicillin Erythromycin Methaqualone Salicylic acid
Ampicillin β-Estradiol Methoxyphenamine Serotonin
Apomorphine Estrone-3-sulfate Methylphenidate Seroquel
Ascorbic acid Ethyl alcohol Metoprolol Sertraline
Aspartame Ethyl-p-aminobenzoate N-Acetylprocainamide Sodium Chloride
Atropine Etodolac Nalidixic acid Sulfamethazine
Benzilic acid Famprofazone Nalorphine Sulindac
Benzoic acid Fenoprofen Naproxen Tetracycline
Benzydamine Fluoxetine Niacinamide Tetrahydrozoline
Brompheniramine Furosemide Nifedipine Theophylline
Caeine Gentisic acid Nimesulide Thiamine
Cannabidiol d-Glucose Norethindrone Thioridazine
Chloral Hydrate Guaiacol Glyceryl Ether Noscapine Tolbutamide
Chloramphenicol Hemoglobin d,l-Octopamine Trans-2-phenylcyclopropylamine
Chloroquine Hydralazine Orphenadrine Trazodone
Chlorothiazide Hydrochlorothiazide Oxalic acid Triamterene
Chlorpromazine Hydrocortisone Oxolinic acid Triuoperazine
Chlorprothixene o-Hydroxyhippuric acid Oxymetazoline Trimethoprim
Cholesterol 3-Hydroxytyramine Papaverine d,l-Tryptophan
Cimetidine Ibuprofen Pemoline d,l-Tyrosine
Clonidine Iproniazid Penicillin Uric acid
Cortisone Isoproterenol Pentazocine Verapamil
Creatinine Isoxsuprine Phenelzine Zomepirac
Deoxycorticosterone Kanamycin Pheniramine
Dextromethorphan Ketoprofen Phenothiazine
Page 9
17
ENGLISH
BIBLIOGRAPHY
1. Tietz NW. Textbook of Clinical Chemistry. W.B. Saunders Company. 1986; 1735
2. Cody B, J.T., “Specimen Adulteration in drug urinalysis. Forensic Sci. Rev., 1990, 2:63.
3. Tsai C, S.C. et.al., J. Anal. Toxicol. 1998; 22 (6): 474
4. Baselt RC. Disposition of Toxic Multi-Drugs and Chemicals in Man. 2nd Ed. Biomedical Publ., Davis, CA. 1982; 488
5. Hawks RL, CN Chiang. Urine Testing for Drugs of Abuse. National Institute for Drug Abuse (NIDA), Research
Monograph 73, 1986
SVT/Adulterant Color Chart
OX
Abnormal Abnormal
Oxidants/Pyridinium
PCC
chlorochromate
NIT Nitrite
Normal Normal S.G. Specic gravity GLUT Glutaraldehyde
pH pH GLUT Creatinine
Index of Symbols
Attention, see instructions
for use
For in vitro
diagnostic use only
30°C
2°C
Store between 2-30°C Lot Number
Keep in a cool, dry place Keep away from sunlight
Manufacturer
GIMA S.p.A.
GIMA Spa
Via Marconi, 1 - 20060
Via Marconi, 1 - 20060
Gessate (MI) - Italia
Gessate (MI) - Italia
Made in China (P.R.C.)
Tests per kit Manufacturer
Use by Do not reuse
Catalog 24550 / 24549 /
24551
Please read instructions
carefully
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