Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
PROFESSIONAL MEDICAL PRODUCTS
MULTI DRUG SALIVA MIDSTREAM TEST 6 DRUGS
8 PARAMETERS - FOR PROFESSIONAL USE
User manual
ATTENTION: The operators must carefully read and completely understand the
present manual before using the product.
A rapid test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human oral uid. For healthcare professionals including professionals at point of care
sites. Immunoassay for in vitro diagnostic use only.
INTENDED USE
The Multi-Drug Rapid Test Midstream for OPI/ COC/ AMP/ OXY/ MET/ THC is a lateral ow
chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in oral uid at the following cut-off concentrations:
Test Calibrator Cut-off (ng/ml)
Opiates (OPI/MOP) Morphine 40
Cocaine (COC) Benzoylecgonine 30
Amphetamine (AMP) d-Amphetamine 40
Oxycodone (OXY) Oxycodone 40
Methamphetamine (MET) d-Methamphetamine 40
Marijuana (THC) 11-nor-Δ9 -THC-9 COOH 10
This assay 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) and gas chromatography/tandem mass
spectrometry (GC/MS) are the preferred confirmatory methods. Professional judgment should be applied to any drug of abuse test result, particularly when preliminary
positive results are indicated.
SUMMARY
The Multi-Drug Rapid Test Midstream for OPI/ COC/ AMP/ OXY/ MET/ THC and their metabolites is a rapid, oral uid screening test that can be performed without the use of an
instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of
specic drugs in human oral uid
Amphetamine (AMP)
Amphetamine is a sympathomimetic amine with therapeutic indications. The drug is often
self-administered by nasal inhalation or oral ingestion. Depending on the route of administration, amphetamine can be detected in oral uid as early as 5-10 minutes following use1.
Amphetamine can be detected in oral uid for up to 72 hours after use1.
The amphetamine assay contained within the Multi-Drug Rapid Test Midstream yields a
positive result when the amphetamine concentration in oral uid exceeds 40ng/ml.
Methamphetamine (MET)
Methamphetamine is a potent stimulant chemically related to amphetamine but with greater CNS stimulation properties. The drug is often self-administered by nasal inhalation,
smoking or oral ingestion. Depending on the route of administration, methamphetamine can
be detected in oral uid as early as 5-10 minutes following use1. Methamphetamine can be
detected in oral uid for up to 72 hours after use1.
The Methamphetamine assay contained within the Multi-Drug Rapid Test Midstream yields
a positive result when the methamphetamine concentration in oral uid exceeds 40ng/ml,or
the 3,4-Methylenedioxymethamphetamine concentration in oral uid exceeds 50ng/ml.
Cocaine (COC)
Cocaine is a potent central nervous system (CNS) stimulant and a local anesthetic derived
from the coca plant (erythroxylum coca). The drug is often self-administered by nasal inhalation, intravenous injection and free-base smoking. Depending on the route of administration,
cocaine and metabolites benzoylecgonine and ecgonine methyl ester can be detected in
oral uid as early as 5-10 minutes following use1. Cocaine and benzoylecgonine can be
detected in oral uid for up to 24 hours after use1.
The cocaine assay contained within the Multi-Drug Rapid Test Midstream for cocaine and
opiates yields a positive result when the cocaine metabolite in oral uid exceeds 30ng/ml.
6-Monoacetylmorphine 4
3,4-Methylenedioxymethamphetamine
(MDMA)
50
Opiates (OPI)
The drug class opiates refers to any drug that is derived from the opium poppy, including
naturally occurring compounds such as morphine and codeine and semi-synthetic drugs
such as heroin. Opiates act to control pain by depressing the central nervous system. The
drugs demonstrate addictive properties when used for sustained periods of time; symptoms
of withdrawal may include sweating, shaking, nausea and irritability. Opiates can be taken
orally or by injection routes including intravenous, intramuscular and subcutaneous; illegal
users may also take the intravenously or by nasal inhalation. Using an immunoassay cutoff
level of 40ng/ml, codeine can be detected in the oral uid within 1 hour following a single
oral dose and can remain detectable for 7-21 hours after the dose1. Heroin metabolite 6-monoacetylmorphine (6-MAM) is found more prevalently in excreted unmetabolized, and is also
the major metabolic product of codeine and heroin2.
The opiates assay contained within the Multi-Drug Rapid Test Midstream yields a positive
result when the opiates concentration in oral uid exceeds 40ng/ml,or the 6-Monoacetylmorphine concentration in oral uid exceeds 4ng/ml.
Marijuana (THC)
11-nor-Δ9-tetrahydrocannabinol-9-carboxylic acid (Δ9-THC-COOH), the metabolite of THC
(Δ9-tetrahydrocannabinol), is detectable in oral uid shortly after use. The detection of the
drug is thought to be primarily due to the direct exposure of the drug to the mouth (oral and
smoking administrations) and the subsequent sequestering of the drug in the buccal cavity3.
Historical studies have shown a window of detection for THC in oral uid of up to 14 hours
after drug use3.
The THC assay contained within the Multi-Drug Rapid Test Midstream yields a positive
result when the Δ9-THC-COOH concentration in oral uid exceeds 10 ng/ml.
Oxycodone (OXY)
Oxycodone is a semi-synthetic opioid with a structural similarity to codeine. The drug is manufactured by modifying thebaine, an alkaloid found in the opium poppy.Oxycodone, like all
opiate agonists, provides pain relief by acting on opioid receptors in the spinal cord, brain,
and possibly directly in the affected tissues. Oxycodone is prescribed for the relief of moderate to high pain under the well-known pharmaceutical trade names of OxyContin®, Tylox®,
Percodan® and Percocet®. While Tylox®, Percodan® and Percocet® contain only small doses of oxycodone hydrochloride combined with other analgesics such as acetaminophen
or aspirin, OxyContin consists solely of oxycodone hydrochloride in a time-release form.
Oxycodone is known to metabolize by demethylation into oxymorphone and noroxycodone.
The OXY assay contained within the Multi-Drug Rapid Test Midstream yields a positive
result when the OXY concentration in oral uid exceeds 40ng/ml.
ASSAY PRINCIPLE
The Multi-Drug Rapid Test Midstream for OPI/ COC/ AMP/ OXY/ MET/ THC is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral
uid specimen compete against their respective drug conjugate for binding sites on their
specic antibody.
During testing, a portion of the oral uid specimen migrates upward by capillary action. A
drug, if present in the oral uid specimen below its cut-off concentration, will not saturate
the binding sites of its specic antibody. The antibody will then react with the drug-protein
conjugate and a visible colored line will show up in the test line region of the specic drug
strip. The presence of drug above the cut-off concentration in the oral uid specimen will
saturate all the binding sites of the antibody. Therefore, the colored line will not form in the
test line region.
A drug-positive oral uid specimen will not generate a colored line in the specic test line
region of the strip because of drug competition, while a drug-negative oral uid specimen
will generate a line in the test line region because of the absence of drug competition.
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.
REAGENTS
The test contains membrane strips coated with drug-protein conjugates (puried bovine
albumin) on the test line, a goat polyclonal antibody against gold-protein conjugate at the
control line, and a dye pad which contains colloidal gold particles coated with mouse monoclonal antibody specic to Amphetamine, Methamphetamine, Cocaine, Opiates, Δ9-THCCOOH and Oxycodone,
PRECAUTIONS
• Do not use after the expiration date.
• The test should remain in the sealed pouch until use.
• Oral uid is not classied as biological hazard unless derived from a dental procedure.
• The used collector and Midstream should be discarded according to local regulations.
STORAGE AND STABILITY
Store as packaged in the sealed pouch at 2-30°C. The test is stable through the expiration
date printed on the sealed pouch. The test Midstream must remain in the sealed pouch until
use. DO NOT FREEZE. Do not use beyond the expiration date.
SPECIMEN COLLECTION AND PREPARATION
The oral uid specimen should be collected using the collector provided with the kit. Follow
the detailed Directions for Use below. No other collection Midstream should be used with
this assay. Oral uid collected at any time of the day may be used.
MATERIALS
Materials Provided
• Test Midstream • Package insert
Materials Required but Not Provided
• Timer
DIRECTIONS FOR USE
Allow the test Midstream, specimen, and/or controls to reach room temperature (1530°C) prior to testing. Instruct the donor to not place anything in the mouth including
food, drink, gum or tobacco products for at least 10 minutes prior to collection.
1. Bring the pouch to room temperature before opening it. Remove the test from the sealed
pouch and use it within one hour.
2. Take off the Midstream cap and insert the absorbent wick to the mouth .put it under the
tongue to collect oral uid until the control line appears and then take out the midstream.
3. Place the test Midstream on a clean and level surface. See illustration below.
4. Read drug strip results at 10 minutes. Do not read results after 15 minutes.
Step 1 Step 2 Step 3
Positive
Negative
Until both control
lines appear
Remove
the cap
INTERPRETATION OF RESULTS
(Please refer to the previous illustration)
NEGATIVE:* A colored line appears in the Control region (C) and colored lines appear
in the Test region (T). This negative result means that the concentrations in the oral uid
sample are below the designated cut-off levels for a particular drug tested.
*NOTE: The shade of the colored lines(s) in the Test region (T) may vary. The result should
be considered negative whenever there is even a faint line.
POSITIVE: A colored line appears in the Control region (C) and NO line appears in the
Test region (T). The positive result means that the drug concentration in the oral uid sam-
ple is greater than the designated cut-off for a specic drug.
INVALID: No line appears in the Control region (C). Insufcient 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 card. If the result is still invalid, contact
your manufacturer.
QUALITY CONTROL
A procedural control is included in the test. A colored line appearing in the control region
(C) is considered an internal procedural control. It conrms sufcient specimen volume,
adequate membrane wicking and correct procedural technique.
LIMITATIONS
1. The Multi-Drug Rapid Test Midstream provides only a qualitative, preliminary analytical
result. A secondary analytical method must be used to obtain a conrmed result. Gas
chromatography/mass spectrometry (GC/MS) or gas chromatography/tandem mass
spectrometry (GC/MS/MS) is preferred conrmatory methods.
2. A positive test result does not indicate the concentration of drug in the specimen or the
route of administration.
3. A negative result may not necessarily indicate a drug-free specimen. Drug may be present
in the specimen below the cutoff level of the assay.
PERFORMANCE CHARACTERISTICS
Analytical Sensitivity
A Phosphate-buffered saline (PBS) pool was spiked with drugs to target concentrations of
± 50% cut-off, ± 25% cut-off and +300% cut-off and tested with the Multi-Drug Rapid Test
Midstream. The results are summarized below.
10 minutes
Invalid
4
Drug Concentration
Cut-off Range
0% Cut-off 30 0 30 0 30 0 30 0 30 0 30 0
-50% Cut-off 30 0 30 0 30 0 30 0 30 0 30 0
-25% Cut-off 27 3 28 2 27 3 27 3 27 3 27 3
Cut-off 15 15 16 14 12 18 15 15 13 17 20 10
+25% Cut-off 7 23 6 24 8 22 8 22 7 23 4 26
+50% Cut-off 0 30 0 30 0 30 0 30 0 30 0 30
+300% Cut-off 0 30 0 30 0 30 0 30 0 30 0 30
Analytical Specificity
The following table lists the concentration of compounds (ng/mL) above which the Multi-Drug Rapid Test Midstream for OPI/ COC/ AMP/ OXY/ MET/ THC identied positive results at a read time of 10 minutes.
AMP MET THC COC OPI OXY
- + - + - + - + - + - +
Compound ng/ml
AMPHETAMINE (AMP)
d-Amphetamine 40
d/l-Amphetamine 100
ß-Phenylethylamine
25,000
Tryptamine 12,500
p-Hydroxyamphetamine 100
(+)3,4-Methylenedioxyamphetamine (MDA) 100
l-Amphetamine 25,000
Methoxyphenamine 12,500
METHAMPHETAMINE (MET)
d-Methamphetamine 40
Fenuramine 60,000
p-Hydroxymethamphetamine 400
Methoxyphenamine 25,000
Mephentermine 1,500
3,4-Methylenedioxymethamphetamine (MDMA) 50
l-Phenylephrine (R)-(-)-Phenylephrine 6,250
Procaine 2,000
(1R,2S) - (-)Ephedrine 400
Ephedrine 400
Benzphetamine 25,000
MARIJUANA (THC)
11-nor-Δ9 -THC-9 COOH 10
Cannabinol 12,500
Δ8 -THC 6,000
Δ9 -THC 10,000
11-nor-Δ8-THC-9 COOH 10
COCAINE (COC)
Benzoylecgonine 20
Cocaine 20
Cocaethylene 30
Ecgonine 1,500
Ecgonine methyl ester 12,500
OPIATES (OPI)
Morphine 40
Codeine 25
Ethylmorphine 25
Hydromorphine 100
Hydrocodone 100
Levorphanol 400
Oxycodone 25,000
Morphine 3-β-D-Glucuronide
50
Norcodeine 6,250
Normorphine 25,000
Nalorphine 10,000
Oxymorphone 25,000
Thebaine 2,000
Diacetylmorphine (Heroin) 50
6-Monoacetylmorphine 4
OXYCODONE (OXY)
Oxycodone 40
Oxymorphone 40
Levorphanol 10,000
Hydrocodone 1,500
Hydromorphone 10,000
Naloxone 5,000
Naltrexone 5,000
Cross-Reactivity
A study was conducted to determine the cross-reactivity of the test with compounds spiked
into drug-free PBS stock. The following compounds demonstrated no false positive results
on the Multi-Drug Rapid Test Midstream when tested with at concentrations up to 100 μg/
mL.
N-Acetylprocainamide Creatinine Meprobamate Quinidine
Acetylsalicylic acid Diazepam Methadone Quinine
Aminopyrine Diclofenac Methylphenidate Secobarbital
Amitryptyline Diunisal Methyprylon Serotonin
Amobarbital Digoxin Nalidixic acid Sulfamethazine
Amoxicillin Diphenhydramine Nifedipine Sulindac
Ampicillin Doxylamine Norcodein Temazepam
L-Ascorbic acid
Apomorphine Estrone-3-sulfate D-Norpropoxyphene Tetrahydrocortisone,
Aspartame Ethyl-p-aminobenzoate Noscapine 3-Acetate
Atropine Fenoprofen D,L-Octopamine Tetrahydrocortisone
Benzilic acid Furosemide Oxalic acid
Benzoic acid Gentisic acid Oxazepam Tetrahydrozoline
Bilirubin Hemoglobin Oxolinic acid Thiamine
(±) - Brompheniramine Hydralazine Oxymetazoline Thioridazine
Caffeine Hydrochlorothiazide Papaverine D, L-Thyroxine
Cannabidiol Hydrocortisone Penicillin-G Tolbutamine
Chloralhydrate O-Hydroxyhippuric acid Pentazocine Triamterene
Chloramphenicol 3-Hydroxytyramine Pentobarbital Triuoperazine
Chlordiazepoxide Ibuprofen Perphenazine Trimethoprim
Chlorothiazide Imipramine Phencyclidine Trimipramine
(±) Chlorpheniramine Iproniazid Phenelzine L-Phenylephrine
Chlorpromazine (±) - Isoproterenol Phenobarbital D, L-Tryptophan
Chlorquine Isoxsuprine Phentermine Tyramine
Cholesterol Ketamine Promazine D, L-Tyrosine
Clomipramine Ketoprofen Promethazine Uric acid
Clonidine Labetalol D,L-Propanolol Verapamil
Cortisone Loperamide D-Propoxyphene Zomepirac
(-) Cotinine Maprotiline D-Pseudoephedrine
β-Estradiol
Norethindrone Tetracycline
(5-Hydroxytyramine)
3 (β-D-glucuronide)
BIBLIOGRAPHY
1. Moolchan, E., et al, “Saliva and Plasma Testing for Drugs of Abuse: Comparison of the Disposition
and Pharmacological Effects of Cocaine”, Addiction Research Center, IRP, NIDA, NIH, Baltimore,
MD. As presented at the SOFT-TIAFT meeting October 1998.
2. Kim, I, et al, “Plasma and oral uid pharmacokinetics and pharmacodynamics after oral codeine
administration”, ClinChem, 2002 Sept.; 48 (9), pp 1486-96.
3. Schramm, W. et al, “Drugs of Abuse in Saliva: A Review,” J Anal Tox, 1992 Jan-Feb; 16 (1), pp 1-9
4. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 2nd Ed. Biomedical Publ., Davis,
CA. 1982; 488.
Index of Symbols
Product complies
Keep away from
sunlight
Keep in a cool,
dry place
Please read
instructions
carefully
Contains sufcient
Σ
for “n” tests
20
Do not use
if package
is damaged
with European
Directive no.
98/79/EC on In
Vitro diagnostic
devices
For in vitro
diagnostic use
only
Read instructions
carefully
30°C
2°C
Store between
and °C
Disposable device,
do not re-use
Expiration date
(see box /
package)
Product code
Lot number
(see box /
package)
Manufacturer
24566 / DSD-863-C
Hangzhou AllTest Biotech Co., Ltd.
#550, Yinhai Street
Hangzhou Economic & Technological Development Area
Hangzhou - 310018, P.R. China
Made in China
MedNet GmbH
Borkstrasse 10 - 48163 Muenster
Germany
M-24566-GB-Rev.1.01.18
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