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Multi-Drug
One Step
AMP •COC• MET•MOP•THC
Screening Test Panel (Urine)
Package Insert
(Catalog Number: DOA-154)
A rapid, one step screening test for the simultaneous, qualitative
detection of multiple drugs and metabolites in human urine.
For professional in vitro diagnostic use only.
INTENDED USE
The ACON Multi-Drug One Step Amphetamine/Cocaine/Methamphetamine
/Morphine/Marijuana Screening Test Panel (Urine) is a lateral flow
chromatographic immunoassay for the qualitative detection of
Amphetamine,
Benzoylecgonine
(Cocaine
metabolite),
Methamphetamine, Morphine and 11-nor-9-Tetrahydrocannabinol9-carboxylic acid (9-THC-COOH) in human urine.
SUMMARY
Urine based screening tests for multiple drugs of abuse range from
simple immunoassay tests to complex analytical procedures. The
simplicity, speed and sensitivity of immunoassays have made them
the most widely accepted method to screen urine for multiple drugs
of abuse.
The ACON Multi-Drug One Step Amphetamine/Cocaine/Methamphetamine/
Morphine/Marijuana Screening Test Panel (Urine) is a rapid, visual,
screening immunoassay that can be used for the simultaneous, qualitative
detection of Amphetamine, Benzoylecgonine (Cocaine metabolite),
Methamphetamine, Morphine, 11-nor-9_Tetrahydrocannabinol-9carboxylic acid (9-THC-COOH) in human urine without the use of an
instrument. The test utilizes monoclonal antibodies to selectively detect
elevated levels of various drugs in urine. The ACON Multi-Drug One Step
Amphetamine/Cocaine/Methamphetamine/Morphine/Marijuana Screening
Test Panel (Urine) yields positive results for the various drugs at the
respective concentrations used: Amphetamine 1000 ng/mL,
Benzoylecgonine 300 ng/mL, Methamphetamine 1000 ng/mL, Morphine
300 ng/mL, THC 50 ng/mL. These are the suggested screening cut-off for
positive specimens set by the Substance Abuse and Mental Health
Services Administration (SAMHSA, USA).
PRINCIPLE
The ACON Multi-Drug One Step Amphetamine/Cocaine/Methamphetamine/
Morphine/Marijuana Screening Test Panel (Urine) uses immunoassays
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 specific antibody.
During testing, a urine specimen migrates upward by capillary
action. A drug, if present in the urine specimen below its cut-off
concentration, will not saturate the binding sites of its specific
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 specific drug
strip. The colored line will not form in the test line region if the
drug level is at or above its cut-off 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 specific test line region of the strip because of drug competition,
while a drug-negative urine 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 of each strip if the test has been performed
properly.
-20°C. Frozen specimens should be thawed and mixed before testing.
PROCEDURE




DIRECTIONS FOR USE
Allow the test panel, urine specimen, and/or controls to
equilibrate to room temperature (15-30C) prior to testing.
1.
2.
REAGENTS
The test panel contains antibody coated particles for specific drugs and
specific drug conjugates coated on the individual test strip membranes.
PRECAUTIONS




For 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 test panel should be discarded in a proper biohazard
container after testing.
Materials Provided
Test panels
Package insert
Materials Required But Not Provided
Specimen collection container
Timer
3.
Bring the pouch to room temperature before opening it. Remove
the test panel from the sealed pouch and use it as soon as possible.
Take off the cap outside of the test end. With arrows pointing
toward the urine specimen, immerse the test panel vertically in the
urine specimen for at least 5 seconds. Do not pass the arrows on
the test panel when immersing the panel. See the illustration below.
Place the test panel on a non-absorbent flat surface, start
the timer and wait for the red line(s) to appear. The results
should be read at 5 minutes. It is important that the
background is clear before the results are read. Do not
interpret results after 10 minutes.
STORAGE AND STABILITY
Store as packaged in the sealed pouch at 4-30°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,
filtered, or allowed settle to obtain clear supernatant for testing.
Specimen Storage
Urine specimens may be stored at 2-°8 C for up to 48 hours prior to
assay. For prolonged storage, specimens may be frozen and stored
below
INTERPRETATION OF RESULTS
(Please refer to illustration above)
POSITIVE: One red line appears in the control region (C) of
the specific drug test. No line appears in the test region (T) of the
specific drug test. The absence of a test line indicates a positive
result for that drug.
NEGATIVE:* Two lines adjacent to each drug name appear.
One red line should be in the control region (C) of the specific drug
test, and another apparent red or pink line adjacent to each drug test
should be in the test region (T) of the specific drug test.
INVALID: Control line fails to appear. Insufficient 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.
* NOTE: The shade of red in the test line region (T) will vary, but
it should all be considered as negative whenever there is even a
faint pink line.
THC
11-nor-9-THC-COOH
50 ng/mL
The ACON Multi-Drug One Step Amphetamine/Cocaine/Methamphetamine/
Morphine/Marijuana Screening Test Panel (Urine) has been shown to
detect these drugs or metabolites in urine at 5 minutes.
QUALITY CONTROL
Specificity
A procedural control is included in the test. A red line appearing in
the control region (C) is the internal procedural control. It confirms
sufficient specimen volume and correct procedural technique. A
clear background is required.
The following compounds produce positive results in their
respective test line region when tested at levels equal to or greater
than the concentrations listed below.
Table 1.
Compound
Concentration(ng/mL)
Amphetamine
o-Amphetamine
1,000
1-Amphetamine
10,000
()3,4- Methylenedioxyamphetamine
5,000
Cocaine
LIMITATIONS
Benzoylecgonine
300
300
The ACON Multi-Drug One Step Amphetamine/Cocaine/Methamphetamine/ Cocaine
Morphine/Marijuana Screening Test Panel (Urine) provides only a Methamphetamine
500
preliminary analytical result. A secondary analytical method must o- Methamphetamine
50,000
be used to obtain a confirmed result. Gas chromatography and mass D-Amphetamine
Chloroguine
50,000
spectrometry (GC/MS) ares the preferred confirmatory methods (2).
()Ephedrine
50,000
The ACON Multi-Drug One Step Amphetamine/Cocaine/Methamphetamine/ 1- Methamphetamine
25,000
Morphine/Marijuana Screening Test Panel (Urine) is a qualitative ()3,4-Methylenedioxymethamphetamine
2,000
screening assay and can not determine either the drug concentration Procaine
10,000
in the urine or the level of intoxication.
-Phenylethylamine
50,000
Ranitidine
50,000
It is possible that technical or procedural errors, as well as
Morphine
other interfering substances in the urine specimen may cause
Morphone
300
erroneous results.
Codeine
300
300
Adulterants, such as bleach and/or alum, in urine specimens may Ethyl morphine
375
produce erroneous results regardless of the analytical method used. Hydrocodnne
400
If adulteration is suspected, the test should be repeated with another Hydromorphone
Merperidine
30,000
urine specimen.
Morphine-3-glucuronide
490
Certain medications containing opiates or opiate derivatives may Norcodeine
30,000
produce a positive result. Additionally, foods and tea containing Oxycodone
15,000
poppy products may also produce a positive result.
Thebaine
30,000
THC
PERFORMANCE CHARACTERISTICS
11-nor-9-THC-9-COOH
50
11-hydroxy-9 Tetrahydrocannabinol
2,500
Sensitivity
9- Tetrahydrocannabinol
10,000
Cannabinol
10,000
The Substance Abuse and Mental Health Services Administration Cannabidiol
100,000
(SAMHSA) has set the following screening cut-off levels (3):
Control standards are not supplied with this kit; however it is
recommended that positive and negative controls be tested as good
laboratory practice to confirm the test procedure and to verify
proper test performance.
AMP
COC
MET
MOP
Amphetamine
Benzoylecgonine
Methamphetamine
Morphine
1000 ng/mL
300 ng/mL
1000 ng/mL
300 ng/mL
Cross-Reactivity
The following compounds show no cross-reactivity when tested
with
the
ACON
Multi-Drug
One
Step
Amphetamine/Cocaine/Methamphetamine/
Morphine/Marijuana Screening Test Panel (Urine) at a concentration of
100 g/mL (Table 2).
Table 2.
Non Cross-Reacting Compounds
Acetamidophenol
(+)-Epinephone
Acetone
(-)-Ephedrine
Albumin
(+)-Epinephrine
Amitriptyline
Erythromycin
Ampicillin
Ethanol
Aspartame
Furosemide
Atropine
Glucose
Benzocaine
Guaiacol glyceryl ether
Bilirubin
Hernoglubin
Calfeine
Hydroxy tyramine
(+)-Chtorpheniramine
Lmipramine
Creatine
()-Isoproterenol
Dexbrompheniramine
Lidocaine
Dextromethorphan
Naloxorie
4-Dimethylaminoantipynne Naltrexone
Dcpamine
Naphthalene acetic acid
Oxalic Acid
Penicillin-G
Pheniramine
Phenothiaxine
Quinidine
Riboflavin
Sodium Chloride
Solindac
Thioridazine
Trimethobenzamide
Tyramine
Vitamin C
BIBLIOGRAPHY
1.
2.
3.
Tietz NW. Textbook of Clinical Chemistry. W.B. Saunders
Company. 1986; 1735
Baselt RC. Disposition of Toxic Multi-Drugs and Chemicals in
Man. 2nd Ed. Biomedical Publ., Davis, CA. 1982; 488
Hawks, RL, CN Chiang. Urine Testing for Multi-Drugs of
Abuse. National Institute for Multi-Drug Abuse (NIDA),
Research Monograph 73, 1986
Distributed By:
Intimex (Holdings) Limited
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