Drug Screen Tests
Visual One-Step Immunoassays for the qualitative detection of specific
drugs in human urine.
For In Vitro Diagnostic Use Only.
GMSI's line of Drug Screen Tests consists of eleven individual
one-step immunoassays. The FirstStep Drug Screen Test is a lateral
flow, one-step immunoassay for the qualitative detection of specific
drugs in human urine at the following cut-off concentrations:
AMP Amphetamine 1000 ng/ml, BAR Barbiturates 300 ng/ml, BZO Benzodiazepines
300 ng/ml, COC Benzoylecgonine 300 ng/ml, M-AMP Methamphetamine
1000 ng/ml, MTD Methadone 300 ng/ml, MOR Morphine 300 ng/ml, MOR
II Morphine II 2,000 ng/ml, PCP Phencyclidine 25 ng/ml, TCA Tricyclic
Antidepressants 1000 ng/ml, THC 11-nor-.9-THC-9-COOH 50 ng/ml
These products are designed to obtain visual, qualitative results
and are intended for professional use. The assay should not be used
without proper supervision and is not intended for over-the-counter
sale to lay persons.
This assay provides only a preliminary analytical test result.
A more specific alternative chemical method must be used in order
to obtain a confirmed analytical result. Gas chromatography/mass
spectrometry (GC/MS) has been established as the preferred confirmatory
method by SAMHSA (Substance Abuse and Mental Health Services Administration).
Clinical consideration and professional judgment should be applied
to any drugs of abuse test result, particularly when preliminary
positive results are indicated.
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SUMMARY OF INDIVIDUAL DRUGS
Amphetamine: Amphetamine is a sympathomimetic
amine whose biological effects include potent central nervous system
stimulation, appetite reduction, hyperthermia, insomnia and euphoria.
Pharmaceutical names of amphetamine include Adderall ® and Dexedrine
®. Common street names include "speed" and "uppers".
The half-life of the drug is approximately 12 hours. The detection
window for amphetamine in urine is 1 to 2 days after use.
Barbiturates: Barbiturates are a class
of central nervous system depressants used medically as sedatives
and anticonvulsants. Members of the barbiturate class include phenobarbital,
pentobarbital, secobarbital, butalbital and amobarbital. Common
physical effects of barbiturate use include impaired motor coordination,
anesthesia, sedation, cardiovascular and respiratory depression.
The half lives of barbiturate range from 2 to 40 hours, depending
on the duration of use. Short acting barbiturates, such as secobarbital
and butalbital, can be detected in urine up to 4 days after use.
Long-acting barbiturates, such as phenobarbital, can be detected
in urine up to 3 weeks.
Benzodiazepines: Benzodiazepines are a
class of drugs frequently prescribed for the treatment of anxiety,
sleep disorders and some seizure conditions. Members of this drug
class include diazepam, chlordiazepoxide, alprazolam and clonazepam.
Physical and psychological effects of benzodiazepine use include
lethargy, reduced motor coordination and drowsiness. Physical dependence
can occur and withdrawal symptoms may appear when the medication
is discontinued. The half-lives of benzodiazepines range from 2
to 40 hours, depending on the duration of use. Benzodiazepines may
be detected in the urine up to 10 days after use.
Cocaine: Derived from the leaves of
coca plant, cocaine is a potent central nervous system stimulant
and local anesthetic. Physical and psychological effects of cocaine
use include increased heart rate, fever, pupil dilation, diaphoresis,
euphoria and increased energy. Biologically, cocaine is rapidly
metabolized to benzolecgonine. The half-life of benzoylecgonine
(5 to 8 hours) is much longer than that of the parent compound cocaine
(0.5 to 1.5 hours). Benzoylecgonine can be detected in urine up
to 3 days after cocaine use.
Methadone: Methadone is a synthetic
analgesic drug primarily used in the treatment of narcotic addiction.
It is administered orally or intravenously and is metabolized in
the liver to EDDP, EMDP and methadol. Physiological effects of methadone
use include respiratory depression, sedation and analgesia. Methadone
overdoses are characterized by stupor, hypotension, pupillary constriction
and clammy skin. Left untreated, methadone overdoses can lead to
coma or death. Methadone has a half-life of 15-60 hours and is detectable
in the urine (as parent methadone EDDP, EMDP and methadol) for up
to 3 days after use.
Methamphetamine: Methamphetamine is
a potent sympathomimetic amine with therapeutic applications. High
doses lead to enhanced stimulation of the central nervous system
and induce euphoria, alertness, and a sense of increased energy.
Other physical responses to methamphetamine use include cardiac
dysrhythmias, paranoia and psychotic behaviors virtually indistinguishable
from schizophrenia. Methamphetamine has a half-life of about 15
hours. In the urine, both methamphetamine and its metabolite amphetamine
can be detected up to 3 days after use.
Morphine: Opiates, including heroin,
morphine, and codeine, are derived from the opium poppy. Medicinally,
opiates are used for pain management and cough reduction. Heroin
is an illicit analog of morphine that breaks down in the body to
6- acetylmorphine, morphine and morphine glucuronide. The biological
half-lives for opiates range from 3-4 hours. In the urine, opiates
are detectable up to 3 days after use. Morphine is the metabolite
of both heroin and codeine; morphine (or morphine glucuronide) in
the urine could indicate morphine, heroin and/or codeine use. Phencyclidine:
Phencyclidine is an arylcyclohexylamine that was originally developed
for use as an anesthetic. Although used in veterinary medicine as
a tranquilizer, the use of the drug in humans was discontinued due
to the negative side effects. PCP is manufactured illegally and
sold on the streets under the names "angel dust", "ozone"
and "crystal cyclone,". Common physical effects of the
drug include hallucinations, disorientation, muscular incoordination
and delusions. The half-life of PCP is about 12 hours. The detection
window in urine is up to 5 days for infrequent use and up to 20
days for chronic use.
THC: Tetrahydrocannabinol (THC) is considered
the most psychoactive of the more than 400 chemicals found in the
marijuana plant (cannabis sativa). Physical and psychological effects
of marijuana use include elevated mood, increased appetite, increased
cardiac output, apathy and altered perception. The ability of the
drug to enhance the appetite has made marijuana attractive for use
with AIDS and cancer patients suffering from nausea and vomiting.
THC is extensively metabolized to 11-nor-o... 9 -THC-9-COOH which
has a half-life of 24 hours. Urine detection limits vary widely
depending on the frequency of drug use. In chronic users, THC-COOH
can remain detectable in the urine for up to 28 days.
Tricyclic Antidepressants: Tricyclic
Antidepressants (TCA), used in the treatment of depressive disorders,
are often implicated in accidental and intentional overdoses. Members
of this drug class include amitriptyline, nortriptyline, imipramine,
desipramine and clomipramine. TCA overdoses can result in profound
central nervous system depression, cardiotoxicity and anticholinergic
effects. Half-lives for these drugs range from 2 to 70 hours. Detection
times in urine vary depending on duration of drug use.
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Each Drug Screen Test is a one-step immunoassay in which a chemically
labeled drug (drug-protein conjugate) competes with the drug which
may be present in urine for limited antibody binding sites. The
test device contains a membrane strip which has been pre-coated
with drug-protein conjugate on the test line region. A colored antibody-colloidal
gold conjugate pad is placed at the end of the membrane. The colored
antibody-colloidal gold conjugate moves along with urine, chromatographically
by capillary action, across the membrane. In the absence of drug
in the urine, the colored antibody colloidal gold conjugate attaches
to the drug-protein conjugate on the test line region to form a
visible line as the antibody/drug-protein conjugate complexes. Therefore,
the formation of a visible precipitant in the test line region occurs
when the test urine is negative for the drug. When the drug is present
in the urine, the drug/metabolite antigen competes with the drug-protein
conjugate on the test line region for the limited antibody binding
sites. When a sufficient amount of drug is present, it will fill
the limited antibody binding sites. This will prevent attachment
of the colored antibody-colloidal gold conjugate to the drug-protein
conjugate on the test line region. Therefore, absence of the color
line on the test region indicates a positive result.
A control or reference line with a different antigen/antibody reaction
is also added to the immunochromatographic membrane strip to indicate
that the test is performed properly. This control line should always
appear regardless of the presence of the drug or metabolite. Therefore,
negative urine will produce two colored lines, and positive urine
will produce only one line. The presence of this colored line in
the control region also serves as verification that 1) a sufficient
volume of urine has been added, and 2) that proper flow was obtained.
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STORAGE AND STABILITY
Test kits should be stored refrigerated or at room temperature
2-30°C (36-86°F). Each device should remain in its sealed
pouch for the duration of the shelf-life.
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- FOR IN-VITRO DIAGNOSTIC USE.
- For professional use only.
- Urine specimens may be infectious. Proper handling and disposal
methods should be established.
- Avoid cross-contamination of urine samples by using a new specimen
collection container and specimen pipette for each urine sample.
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- 25 individually wrapped test devices which include one disposable
pipette each. Each test device contains a membrane coated with
drug-protein conjugate and a colloidal gold conjugate pad coated
with anti-drug antibody.
- One instruction sheet.
MATERIALS REQUIRED BUT NOT PROVIDED
- Specimen collection container.
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SPECIMEN COLLECTION AND HANDLING
Each Drug Screen Test is formulated for use with urine specimens.
Fresh urine does not require any special handling or pretreatment.
Urine samples should be collected such that testing may be performed
as soon as possible after the specimen collection, preferably during
the same day. The specimen may be refrigerated at 2-8°C for
2 days or frozen at -20°C for a longer period of time. Specimens
that have been refrigerated must be equilibrated to room temperature
prior to testing. Specimens previously frozen must be thawed, equilibrated
to room temperature, and mixed thoroughly prior to testing.
Note: Urine specimens and all materials coming in contact with them
should be handled and disposed of as if capable of transmitting
infection. Avoid contact with skin by wearing gloves and proper
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Review "Specimen Collection" instructions. If refrigerated,
the test device, patient samples and controls should be brought
to room temperature (20-30°C) prior to testing. Do not open
pouches until ready to perform the assay.
1. Remove the test device from its protective pouch. If the Drug
Screen Test has been refrigerated, bring the device to room temperature
before opening the pouch to avoid condensation of moisture on the
membrane. Label the device with patient or control number.
2. Draw the urine sample to the line marked on the pipette (approximately
0.2 ml). Dispense the entire contents into the sample well. Use
a separate pipette and device for each sample or control.
3. Results may appear as early as 5 minutes. Verify positive results
at a read time of 8 minutes. Do not interpret result after 8 minutes.
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INTERPRETATION OF RESULTS
Two colored lines should be observed in the viewing window. The
line in the test region (T) is the drug probe line; the line in
the control region (C) is the control line, which indicates proper
performance of the device. The color intensity of the test line
may be any shade of pink and may be weaker or stronger than that
of the control line.
Only one colored line appears in the control region (C). The absence
of a test line indicates a positive result. A positive result should
not be considered conclusive and should be confirmed with a more
specific alternative chemical method such as GC/MS.
No line appears in the control region. Under no circumstances should
a positive sample be identified until the control line forms in
the viewing area. If the control line does not form, the test result
is invalid and the assay should be repeated.
- The assay is designed for use with human urine only.
- A positive result with any of the tests indicates the presence
of a drug/metabolite only and does not indicate or measure intoxication.
- There is a possibility that technical and/or procedural errors
as well as other substances or factors not listed may interfere
with the test and cause incorrect results. See SPECIFICITY for
lists of substances that will produce positive results, or that
do not interfere with the test performance.
- If it is suspected that the samples have been mislabeled or
tampered with, a new specimen should be collected and the test
should be repeated.
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Good laboratory practice recommends the use of control materials
to ensure proper kit performance. Before using a new kit, positive
and negative controls should be tested. Quality control specimens
are available from commercial sources. When testing the positive
and negative controls, use the same assay procedure as with a urine
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For each individual drug screen assay, approximately (60) sixty
urine samples of specific drugs were obtained from clinical laboratories.
The concentration of drug present in the samples was determined
by either GC/MS, HPLC or commercial kits. Each sample was then tested
with a FirstStep Drug Screen Test. Additionally, approximately one
hundred (100) urine samples, collected from presumed non-user volunteers,
were tested. The results are as follows:
The precision of the FirstStep Drug Screen Card was determined by
conducting testing at four clinical sites with spiked urine controls
containing known amounts of each drug found on the panel assay.
In clinical testing, the precision of the FirstStep Drug Screen
Card was determined to be an average of 99% correlation with specimens
containing drugs targeted at 50% of the cut-off value for each drug
and greater than 99% correlation with specimens containing drugs
targeted at 200% of the cut-off value for each drug.
The specificity for the drug screen assays with each FirstStep Drug
Screen Test was evaluated by adding various drugs, drug metabolites,
and other compounds that are likely to be present in urine to the
testing sample. All compounds were prepared in drug-free normal
human urine. The following structurally related compounds produced
positive results with the specified drug screen assays when tested
at levels equal to or greater than the concentrations listed below.
Compound Concentration (ng/ml)
Amphetamine, d-Amphetamine 1,000, I-Amphetamine 10,000, (+/-)3,4-methylenedioxyamphetamine
(MDA) 5,000, Phentermine 1,000, Tyramine 75,000, Barbiturates, Secobarbital
300, Allobarbital 1,000
(+/-)3,4-methylenedioxymethamphetamine (MDMA) 2,000
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine (EDDP) 50,000
Ethyl Morphine 300
Ethyl Morphine 2,000
With the exception of each drug listed above the following compounds
were found not to cross-react with any of the drug strips included
in the Drug Screen Test. Each compound was found not to cross react
when tested at concentrations up to 100 mg/ml.
Acetaminophen, Acetone, Albumin, Amoxapine,
Ampicillin, Aspartame, Aspirin, Atropine, Baclofen, Benzocaine,
Benzafibrate, Billirubin, (+)Brompheniramine, Caffeine, Carbamate,
Carbamazepine, Carisoprodol, (+)-Chlorpheniramine, (+/-)-Chlorpheniramine,
Chlorpromazine, Chlorprothixene, Chlorthalidone, Clofibrate, Creatine,
Creatinine, r-Cyclodextrin, Cyproheptadine, Dantrolene, Dexamethasone,
Dexbrompheniramine, Dextromethorphan, 4-Dimethylaminoantipyrine,
Diphenhydramine, 5,5-Diphenylhydantoin, Dopamine, Ecgonine, Ecgonine
Methyl Ester, (-)-y- Ephedrine, (+)-y- Ephedrine, (+/-)-Epinephrine,
Erythromycin, Ethanol, Fenofibrate, Fentanyl, Fluoxetine, Gemfibrozil,
Glucose, Guaicol Glyceryl ,Ether, DL-Homatropine, Hemoglobin, Hydrochlorothiazide,
Ibuprofen, (+/-)-Isoproterenol, Ketamine, Lidocaine, Maprotiline,
Methanol, 2-IN-morpholinolathanesaltonic, acid, Methaqualone, (1R,2S)-(-)-N-Methyl-Ephedrine,
Naltrexone, Naphthalene Acetic Acid, (+)-Naproxen, (-)-Nicotinic
Acid, Norcodeine, (+/-)-Norephedrine, Noscapine Hydrochloride, Orphenadrine,
Oxalic Acid, Pentazocine, Penicillin-G, Phenothiazine, Phenelzine,
Pheniramine, L-Phenylephrine, Primidone, Procaine, Promethazine,
2-Propylantanoic acid, Pseudoephedrine, d-Propoxyphene, Quinidine,
Quinine, Riboflavin, Salicyclic Acid, Sodium Chloride, Sulindac,
Theophylline, Thioridazine, cis-Thiothixene, D(+)-Trehalose, Trifluoperazine,
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