Download One Step Marijuana Single Drug Test

THC
Store m prckaged in the sealed pouch at 2-30"C (36-86"F). The test card md/or strip test is stable through
the expiration date printed on the sealed pouch. The test card and/or strip test must remain in the sealed
pouch mtil use. DO NOT FREEZE. Do not use beyond the expiration date.
One Step
Marijuana SingleDrug Test (Urine)
PackageInsert
(for single test curd and single test strip formuts)
A rapid, one step testfor the qualitative detection of muijaana
For healthcare professionals
including
professionals
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The uine specimen must be collected in a clem and dry container. Urine collected at any time of the day
my be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to
settle to obtain a clear specimen for testing.
in human uine
at point of cue sites.
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For in vitro diagnostic we only.
for the qulitative detectron
The Muijuana Single Drug Test is a lateral flow chromatographic imuoassay
of I 1-nor-Ae-THC-9 COOH (THC metabolite) in hman urine at a cut-off concentration of 50 ng/ml-.
Urine specimens may be stored at 2-8'C for up to 48 hous prior to testing. For prolonged storage,
specimens may be frozen md stored below -20'C. Frozen specimens should be thawed md mixed before
testing-
This assay provides only a preliminary analytical test result. A more specific alternate chemical
method must be used in ord€r to obtain a confirned analltical result. Gas chromatography/mass
(GCIMS) is the preferred
method. Clinical consideration and
confirmatory
spectrometry
when
professional judgment should be applied to any drug of abuse test result' particularly
preliminary
Test cards and/or test strips
Package insert
positive results are indicated.
Specimen collection container
Timer
When smoked
is the primary active ingredient in camabinoids (mrijuma).
l-HC (Ae--tetrahydrocmabhol)
or orally administered, it produces euphoric effects. Users have impaired short term memory and slowed
learning. They my also experience transient episodes of confusion and miety. Long tem relatively healy
occm il 20-30
use my be associated with behavioral disorders. The peak effect of smoking mrijuma
metabolites tre
minutes and the duation is 90-120 minutes after one cigarette. Elevated levels ofuinary
fomd within hous of exposure and remail detectable for 3-10 days after smoking. The main metabolite
acid (Ae-THC-CooH).
excreted in the urine is 1 1-nor-Ae-tetrahydrocamabinol-9-caboxylic
Extemal controls
Allow the test card and/or test strip, urine specimen, and/or controls to reech room t€mperature (15-
30'C) prior to testing.
1.
Bring the pouch to room temperature before opening it. Remove the test ctrd from the sealed pouch
The Mmijuma Single Drug Test is a rapid uine screening test that cm be perfomed without the use of an
in
instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of mrijuma
2.
Remove the cap.
urine.
3.
With the anow pointing toward the urine specimen, imerse
in mine
The Mrijuana
Single Drug Test yields a positive result when the concentration of mrijuna
exceeds 50 nglml. This is the suggested screening cut-off for positive specimens set by the Substance
Abuse md Mental Health SeruicesAdministration (SAMHSA, USA).r
Single Drug Test is an chromtographic imunoassay based on the principle of competitive
binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding
sites on the antibody.
if present in the urine
Duing testing, a urine specimen migrates upward by capillary action. Mrijuana,
specimen below 50 nglml-, will not saturate the binding sites of the antibody coated particles in the test strip.
The Mmijuma
and use it as soon as possible.
4-
not above the arrow on the test card. [See image (1).1
Replace the cap md place the test card on a non-absorbent flat surface.
Start the timer and wait for the colored line(s) to appear.
o.
The result should be read at 5 minutes. Results may be stable up to I hour after test initiation.
l.
Bring the pouch to room temperatue before opening it. Remove the test ship from the sealed pouch
nHttffil|xqlllE6a1!f,!
md use it as soon as possible.
z.
With anows pointing
towrd
J.
antibody-coupled
and./or test strip contains mouse monoclonal anti-Mrijuma
conjugate. A goat antibody is employed in the control line system.
particles and
For healthcme professionals including professionals at point of care sites.
For in vitro diagnostic use only. Do not use after the expiration date.
The test card md/or test strip should remain in the sealed pouch mtil use.
as m
All specimens should be considered potentially hazardous and handled in the same mmer
infectious agent.
The used test ctrd md/or test strip should be discarded according to federal, state and local
regulations.
specimen, imerse
the test stdp vertically
in the uine
Place the test strip on a non-absorbent flat surface.
Start the tiner and wait for the colored line(s) to appear.
5.
The result should be read at 5 minutes. Results may be stable up to t hour after test initiation.
(Pleaserefer to the illustration below)
NEGATM:*
Marijuana-protein
the uine
specimen for at least l0 to 15 seconds. Immerse the strip to at least the level of the wala lines, but
do not pass the maximum line (MAX) on the test strip. [See image (2)']
To serve as a procedual 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 occmed.
The test crd
in the uflne
5.
mmijuana conjugate md a visible
The antibody coated particles will then be captured by imobilized
colored line will show up.in the test line region. The colored line will not fom in the test line region ifthe
mtibodies.
mrijma
level is above 50 nglml because it will saturate all the binding sites of anti-mrijuma
A drug-positive urine specimen will not generate a colored line in the test line region because of drug
competition, while a drug-negative uine specimen will generate a line in the test line region because ofthe
absence of drug competition.
the test cmd vertically
s pec i m enfor atl eas tl 0to15s ec onds . Im m er s eth e s t ri p t o a t l e a s t t h e l e v e l o f t h e w a ra l i n e s ' b u t
Two lines appear. One colored line should be in the control region (C), and another
apprent colored line should be in the test region (T). This negative result indicates that the mtrijuana
concentration is below the detectable level (50 nglml-).
* NOTE: The shade of color in the test line region (T) will vmy, but it should be considered negative
whenever there is even a faint line
One colored line appears in the control region (C). No line appears in the test region (T).
This positive result indicates that the marijuara concentration exceeds the detectable level (50 ng/ml-)
POSITWE:
IYVALID:
Control line fails to appear. Insufhcient specimen volume or inconect procedural techniques
are the most likely reasons for control line failure. Review the procedure md repeat the test using a new test
cartyor test strip. If the problem persists, discontinue use of the lot imediately
and contact your distributor.
Marijuana Single Test Card
IMAGE 1
if [i*'*""'"
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Positive
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Remove Cap
Marijuana Single Test Strip
IMAGE 2
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Negative
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Positive
Invalid
A procedural control is included in the test. A colored line appearing in the Control region (C) is considerbd
an internal positive procedural control. lt confims suffrcient speoimen volume, adequatemembrane wicking
and conect 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 confirm the test procedure and to verify proper test
performance. Users should follow local, state, and federal guidelines for testing QC materials.
The Marijuana Single Drug Test provides only a qualitative, preliminary anallical result. A secondary
analltical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry
(GC/MS) is the prefened confimatory method.l2
2.
It is possible that technical or procedural enors, as well as other interfering substances in the urine
specimen may cause enoneous results.
3. Adulterants, such as bleach and/or alum, in urine specimens may produce eroneous results regardless
of the analyical 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 or
intoxication, administration route or concentration in udne.
5. A Negative Result may not necessarily indicate drug-free urine. Negative results can be obtained when
drug is present but below the cutoff level ofthe test.
6. This test does not distinguish between drugs ofabuse and certain medicalions.
M
A three way side-by-side comparison was conducted using the Mrijuma
Single Drug Test and a
leading commercially available THC rapid test. Testing was perfomed on specimens previously
collected from subjects presenting for Drug Screen Testing. Presumptive positive results were
confimed
Twenty-six (26) uine samples of nomal, high, and low specific gravity ranges were spiked with 25 nglml,
ard 75 nglmL of 1l-nor-Ae-Tetrahltrocmabinol-9-carboxylic
acid, respectively. The Marijuana Single
Drug Test was tested in duplicate using the twenty-six neat and spiked urine smples. The results demonshate
that varying mges of winary specific gmvity does not affect the test results.
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by GC/MS. The following results were tabulated:
Method
Other THC RaDid Test
Positive
Nesative
Results
The Mrijuana
Single Drug Test
140
3
t43
Positive
Nesafive
Total Results
Total
Results
0
157
157
140
160
300
The pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in I pH unit increments md
spiked with 1l-nor-Ae-Tetrahytrocamabinol-9-carboxylic to 25 nglmL and75 nglnL. The spiked, pHadmted uine wm tested with the Mrijmna
Single Drug Test in duplicate and interpreted according to the
package insert. The results demonsfiate that varying ranges of pH does not interfere with the perfomnce of
the test.
@
Total Agreement: 99o%
When compared to GC/MS, the following results were tabulated:
Method
A study was conducted to detemine the cross-reactivity of the test with compounds in drug free urine. The
following
GC/MS
Results
Positive
Negative
The Mmijrrana $hg1s
Drug Test
Positive
Total Rmults
Neeative
135
5
154
t5 9
o
140
160
_100
compounds show no cross-reacfivity
when tested with the Marijuana
Single Drug Test at a
concentmtion of 100 pglml-:
4-Acetamidophenol
p-Estradiol
p-Hydroxy-methamphetamine
Acetophenetidin
Estrone-3-sulfate
Papaverine
N-Acetylprocainamide
Ethyl-p-minobeuoate
Penicillin-G
Acetylsalicylic acid
Fenoprofen
Pentazocine
A study was conducted using the same clinical specimens with ten percent (10%) distribution at 25olo above
and below the 50ng/ml cut-off at three geographically distinct point of care sites to detemine the accuacy
of the Maijuana Single Drug Test in the hands of point of cre user. Forty (40) positive specimens md forty
(40) negative specimens were tested on three (3) different lots ofeach product.
Aminopyrine
Fuosemide
Pentobarbital
Amitryptyline
Gentisic acid
Perphenazine
Amobrbital
Hemoglobin
Phencyclidine
Amoxicillin
Hydralzine
Phenelzine
The difference in sensitivity md specificity results obtained by the laboratory professional for the sme
clinical specimens compared to the results obtained by the point of ctre (mtrained) user was insignificant.
At a ninety-five percent (95%) confidence interval, th€ odds ratio for the point of care user ves6 the
laboratory professional was 1 to 1 for sensitivity md specificity.
Ampicillin
Hydrochlorothizide
Phenobarbital
Ascorbic acid
Hydrocodone
Phentemine
d,l-Amphetanine
Hydrocortisone
l-Phenylephrine
l-Amphetamine
o-Hydroxyhippuric acid
Apomorphine
3-Hydroxytlramine
B-Phenylethylamine
Phenylpropmolamine
Aspartame
Ibuprofen
Prednisolone
Atropine
Imipramine
Prednisone
Iproniazid
Procaine
Total Results
RelativeSensitivity:96%
r41
RelativeSpecificity:97%
Acuncy:96Yo
tffifiltGlitE
@
A drug-free uine pool was spiked with 1l-nor-Ae-Tehahytrocamabinol-9-crboxylic
acid at the following
concentrations: 75 nglrrL,62.5 nglrnl,37.5 nglnl-,25 ng/ml-, md 0 nglml. The result demonstrates >99olo
accwacy at 50%oabove and 50olobelow the cut-offconcentration.
The data ae smarized
below:
Percent of
(nslmLl
Cutoff
Visual Result
n
0
25
0
30
50v.
30
37.5
75%
50
62.5
cutoff
125V"
30
30
75
150v,
Negative
Positive
30
30
0
0
12
18
29
29
30
30
0
l0
g@
The following table lists compounds and their respective concentrations in uine that leld
in the Marijuana Single Drug Test at 5 minutes.
Compound
Concentration(ng/ml)
Camabinol
20,000
30
1l-nor-48 - THC-9 COOH
50
I l-nor-ae -THC-g cooH
15,000
48 -THC
15,000
A9.THC
a positive result
@
A study was conducted at 3 physicim's offices by mtrained opffitors using 3 different lots of product to
demonstrate the within m, between m md betwem operator precision. An identical pmel of coded
specimens containhg, according to GC/MS, no THC, 25olo THC above and below the cut-off md 50% THC
above and below the 50 nglml- cut-o{I wm provided to each site. For the specimens below the -25 o/ocut-off
concentration, the 3 sites demonstrated 98o%agreement with each other. For the -25yo to +25olo cut-off
specimens, the 3 sites demonstrated 83oloagreement with each other. For specimens above lhe +25olo cut-off
concentration, the 3 sites demonstrated 94%o agremnt
with each other. For all results, the 3 sites were
fomd to have a 91oloasreemmt with each other.
Beuilic
acid
Beuoic acid
(-) Isoproterenol
Promzine
Bemoylecgonine
Isoxsuprine
Promethazine
Benzphetmine
Ketmine
d,l-Propmolol
Bilirubin
Ketoprofen
d-Propoxyphene
Bromphenirmine
Labetalol
d-Pseudoephedrine
Caffeine
Levorphanol
Quinidine
Cannabidiol
Lopermide
Chloral-hydrate
Maprotiline
Quinine
Rmitidine
Chlormphenicol
Meprobamate
Salicylic acid
Chlordizepoxide
Methadone
Secobrbital
Chlorothizide
Methoxlphenamine
Serotonin (5-Hydroxytyramine)
(-+) Chlorpheniramine
(+) 3,4-Methylenedioxy-amphetamine
Sulfmethzine
Chlorpromzine
(+) 3,4-Methylenedioxy-
Sulindac
Chlorquine
methamphetamine
Temzepm
Cholesterol
Methylphenidate
Tetracycline
Clomipramine
Methlprylon
Tetrahydrocortisone, 3 Acetate
Clonidine
Morphine-3-B-D-glucuronide
Tetralydrocortisone
Cocaine hydrochloride
Nalidixic acid
Tetralydrozoline
Codeine
Nalorphine
Thebaine
Cortisone
Naloxone
Thiamine
(-) Cotinine
Naltrexone
Thioridazine
Creatinine
Naproxen
d,l-Thpoxine
Deoxycorticosterone
Niacinamide
Tolbutamine
Dextromethorphan
Nifedipine
Triamterene
Diuepam
Norcodein
Trifluoperzine
3 (B-D glucuronide)
Diclofenac
Norethindrone
Diflmisal
d-Norpropoxyphene
Digoxin
Noscapine
Diphenhydramine
d,l-Octopamins
Doxylmine
Oxalic acid
Ecgonine hydrochloride
Oxazepam
Ecgonine methylester
Oxolinic acid
(-) Y Ephedrine
Oxycodone
Erythromycin
Ox)metazoline
Trimethoprim
Trimiprmine
Tryptamiae
d,l-Tryptophan
Tyramine
d/l-Tlrosine
Uric acid
Verapamil
Zomepirrc
Hawks RL, CN Chiang. Urine Testingfor Dmgs of Abase. National Institute for Drug Abuse (NIDA),
Research Monograph 73, 1986
Baselt RC. Disposifion of Toxic Drugs and Chemicals in Man 2nd Ed. Biomedical Publ., Davis, CA.
1982:488
Printed in China
DN: 1155042601
Eff. Date:2010-05-28