Home
Catalogue
Contact us
One Step Multi-Drug Urine Test Panel
One Step Multi-Drug Urine
Test panel offers any combination from 2 to 12 drugs of
abuse tests for 12 different drugs: Amphetamine (AMP),
Barbiturates (BAR), Benzodiazepines (BZO), Cocaine (COC),
Marijuana (THC), Methadone (MTD), Methamphetamine (MET),
Methylenedioxymethamphetamine (MDMA), Morphine (MOP), Opiate
(OPI 2000), Phencyclidine (PCP), Tricyclic Antidepressants (TCA)
This package insert applies to all combinations of
multi-drug tests panel. Therefore, some information on the
performance characteristics of the product may not be
relevant to your test. We refer to the labels on the
packaging and the prints on the test strip to identify which
drugs are included in your test.”
A rapid one step test
for the qualitative detection of drug of abuse and their
principal metabolites in human urine at specified cut off
level.
For professional use only, For in vitro diagnostic use.
One
Step Multi-Drug Urine Test Panel is consisted of twelve
individual one-step immunoassays. The test is a lateral
flow, one-step immunoassay for the qualitative detection of
specific drugs and their metabolites in human urine at the
following cut off concentrations:
|
Test |
Calibrator |
Cut off
(ng/ml) |
|
Amphetamine
|
Amphetamine |
1,000
|
|
Barbiturates |
Secobarbital |
300 |
|
Benzodiazepines |
Oxazepam |
300 |
|
Cocaine |
Benzoylecgonine |
300 |
|
Marijuana |
Marijuana |
50
|
|
Methadone |
Methadone |
300 |
|
Methamphetamine |
Methamphetamine |
300 |
|
Methylenedioxymethamphetamine |
3,4-Methylenedioxymethamphetamine HCl(MDMA) |
500 |
|
Morphine
|
Morphine |
300 |
|
Opiate
|
Morphine |
2000 |
|
Phencyclidine |
Phencyclidine |
25 |
|
Tricyclic
Antidepressants |
Notriptyline |
1,000 |
This assay provides only a preliminary 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) is the preferred
confirmatory method. Clinical consideration and professional
judgment should be applied to any drug of abuse test result,
particularly when preliminary results are positive.
One
Step Multi-Drug Urine Test Panel is a competitive
immunoassay that is used to screen for the presence of drugs
of abuse in urine. It is chromatographic absorbent device in
which drugs or drug metabolites in a sample competitively
combined to a limited number of antibody-dye conjugate
binding sites.
When sample drug levels are at or above the target cutoff,
the free drug in the sample binds to the antibody-dye
conjugate preventing the antibody-dye conjugate from binding
to the drug-protein conjugate immobilized in the Test Region
(T) of the device. This prevents the development of a
distinct colored band in the test region, indicating a
potentially positive result.
When the absorbent end of the test device is immersed into
the urine sample, the urine is absorbed into the device by
capillary action, mixes with the antibody-dye conjugate, and
flows across the pre-coated membrane. When sample drug
levels are zero or below the target cutoff (the detection
sensitivity of the test), antibody-dye conjugate binds to
the drug /protein conjugate immobilized in the Test Region
(T) of the device. This produces a colored Test line that,
regardless of its intensity, indicates a negative result.
To
serve as a procedure control, a colored line will appear at
the Control Region (C), if the test has been performed
properly.
ˇ
This kit is for external use only. Do not swallow.
ˇ
Discard after first use. The test cannot be used more than
once.
ˇ
Do not use test kit beyond expiry date.
ˇ
Do not use the kit if the pouch is punctured or not well
sealed.
ˇ
Keep out of the reach of children.
ˇ
Do not read after 5 minutes
ˇ
Store at 4 ~ 25 ēC in the sealed pouch up to the expiration
date.
ˇ
Keep away from direct sunlight, moisture and heat.
ˇ
DO NOT FREEZE.
ˇ 25 Tests
ˇ
Package insert
|
Material
Required But Not Provided |
ˇTimer
ˇ 25 Urine cup
|
SPECIMEN
COLLECTION AND PREPARATION |
Collect a urine sample in the urine cup. Urine specimens may
be refrigerated (2-8°C) and stored up to forty-eight hours.
For longer storage, freeze the samples (-20°C or below).
Bring frozen or refrigerated samples to room temperature
before testing. Use only clear aliquots for testing.
Test must be in room temperature (18ēC to 30ēC)
1.
Open the sealed pouch by tearing along the notch. Remove the
test device from the pouch.
2.
Hold the one side of the device with one hand. Use the other
hand to pull out the cap and expose the absorbent end.
3.
Immerse the absorbent end into the urine sample about 10
seconds. Make sure that the urine level is not above the
“MAX” line printed on the front of the device.
4.
Lay the device flat on a clean, dry, non-absorbent surface.
5. Read the result at 5 minutes. Do not read after 5 minutes.
|
INTERPRATATION OF RESULTS |
Positive (+)
A
rose-pink band is visible in each control region. No color
band appears in the appropriate test region. It indicates a
positive result for the corresponding drug of that specific
test zone.
Negative (-)
A rose-pink band is
visible in each control region and the appropriate test
region. It indicates that the concentration of the
corresponding drug of that specific test zone is below zero
or the detection limit of the test.
Invalid
If a color band is not
visible in each of the control region or a color band is
only visible in each of the test region, the test is
invalid. Another test should be run to re-evaluate the
specimen. Please contact the distributor or the store, where
you bought the product, with the lot number.
Note:
There is no meaning attributed to line color intensity or
width.
Though there is an
internal procedural control line in the test device of
Control region, the use of external controls is strongly
recommended as good laboratory testing practice to confirm
the test procedure and to verify proper test performance.
Positive and negative control should give the expected
results. When testing the positive and negative control, the
same assay procedure should be adopted.
1. This test has been
developed for testing urine samples only. The performance of
this test using other specimens has not been substantiated.
2. Adulterated urine
samples may produce erroneous results. Strong oxidizing
agents such as bleach (hypochlorite) can oxidize drug
analyses. If a sample is suspected of being adulterated,
obtain a new sample.
3. This test is a
qualitative screening assay. It is not designed to determine
the quantitative concentration of drugs or the level of
intoxication
4．It
is possible that technical or procedural errors, as well as
other interfering substances in the urine specimen may cause
erroneous results.
5. A negative result may
not necessarily indicate drug-free urine. Negative results
can be obtained when drug is present but below the cut-off
level of the test.
6. Test does not
distinguish between drugs of abuse and certain medicines.
7. A positive result might
be obtained from certain foods or food supplements.
|
PERFORMANCE CHARACTERISTICS |
A
comparison was conducted using each of the tests and
commercially available drug rapid test (Acon One Step
Multi-Line Screen Test Panel with Integrated E-Z Split Key
IM Cup (Urine)). 580 specimens were used in the test.
Positive results were confirmed by GC/MS. The results were
listed as follows:
% Agreement with
commercial kit
|
Specimen |
AMP |
BAR |
BZO |
COC |
THC |
MTD |
MET |
MDMA |
MOP
300 |
OPI
2000 |
PCP |
TCA |
|
Positive |
>99% |
97.5% |
95% |
100% |
95% |
90% |
>99% |
95% |
97.5% |
97.5% |
97.5% |
95% |
|
Negative |
>99% |
99% |
100% |
99% |
99% |
99% |
>99% |
99% |
99% |
99% |
99% |
99% |
|
Total |
>99% |
98.6% |
97.9% |
>99% |
97.9% |
96.4% |
>99% |
97.9% |
98.6% |
98.6% |
98.6% |
97.9% |
% Agreement with GC/MS
|
Specimen |
AMP |
BAR |
BZO |
COC |
THC |
MTD |
MET |
MDMA |
MOP
300 |
OPI
2000 |
PCP |
TCA |
|
Positive |
94% |
92% |
97% |
96% |
95% |
95% |
99% |
97% |
98% |
99% |
91% |
95% |
|
Negative |
99% |
98% |
97% |
99% |
96% |
99% |
99% |
99% |
98% |
99% |
99% |
99% |
|
Total |
97% |
95% |
97% |
98% |
96% |
97% |
99% |
98% |
98% |
99% |
95% |
97% |
Standard drugs were spiked
into urine samples to the concentration of ą 50% cut off and
ą 25%
cut off. The results were
summarized below.
|
Drug Conc.
(Cut-off range) |
n |
AMP |
BAR |
BZO |
COC |
THC |
MTD |
|
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
|
0% Cut-off |
30 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
|
-50% Cut-off |
30 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
|
-25% Cut-off |
30 |
25 |
5 |
26 |
4 |
26 |
4 |
25 |
5 |
25 |
5 |
23 |
7 |
|
Cut-off |
30 |
12 |
18 |
10 |
20 |
14 |
16 |
12 |
18 |
15 |
15 |
14 |
16 |
|
+25% Cut-off |
30 |
5 |
25 |
8 |
22 |
5 |
25 |
6 |
24 |
6 |
24 |
3 |
27 |
|
+50% Cut-off |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
|
Drug Conc.
(Cut-off range) |
n |
MET |
MDMA |
MOP 300 |
OPI 2000 |
PCP |
TCA |
|
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
|
0% Cut-off |
30 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
|
-50%
Cut-off |
30 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
|
-25%
Cut-off |
30 |
25 |
5 |
23 |
7 |
24 |
6 |
25 |
5 |
26 |
4 |
24 |
6 |
|
Cut-off |
30 |
13 |
17 |
10 |
20 |
10 |
20 |
14 |
16 |
15 |
15 |
14 |
16 |
|
+25%
Cut-off |
30 |
5 |
25 |
4 |
26 |
3 |
27 |
5 |
25 |
7 |
23 |
6 |
24 |
|
+50%
Cut-off |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
To test the specificity of
the test, the test device was used to test various drugs,
drug metabolites and other components that are likely to be
present in urine, All the components were added to drug-free
normal human urine. These concentrations (ng/mL) below also
represent the limits of detection for the specified drugs or
metabolites.
|
Amphetamine |
Methamphetamine |
|
|
d-Amphetamine |
1,000 |
D(+)-Methamphetamine |
300 |
|
d.1-Amphetamine |
3,000 |
D-Amphetamine |
15,000 |
|
1-Amphetamine |
50,000 |
Chloroquine |
15,000 |
|
(+/-)3,4-methylenedioxyamphetamine |
5,000 |
(+/-)-Ephedrine |
15,000 |
|
Phentermine |
3,000 |
(-)-Methamphetamine |
7,500 |
|
Barbiturates |
(+/-)3,4-methylenedioxumethamphetamine(MDMA) |
600 |
|
Secobarbital |
300 |
b-Phenylethylamine |
15,000 |
|
Amobarbital |
300 |
Trimethobenzamide |
3,000 |
|
Alphenol |
150 |
|
|
|
Aprobarbital |
200 |
Methylenedioxymethamphetamine(MDMA) |
|
Butabarbital |
75 |
3,4-MethylenedioxymethamphetamineHCl(MDMA) |
500 |
|
Butathal |
100 |
3,4-MethylenedioxyamphetamineHCl |
3,000 |
|
Butalbital |
2,500 |
3,4-Methylenedioxyethylamphetamine |
300 |
|
Cyclopentobarbital |
600 |
Morphine |
|
|
Pentobarbital |
300 |
Morphine |
300 |
|
Phenobarbital |
100 |
Codeine |
300 |
|
Benzodiazepines |
EthylMorphine |
300 |
|
Oxazepam |
300 |
Hydrocodone |
5,000 |
|
Alprazolam |
200 |
Hydromorphone |
5,000 |
|
a-Hydroxyalprazolam |
1,500 |
Morphinie-3-b-d-glucuronide |
1,000 |
|
Bromazepam |
1,500 |
Thebaine |
30,000 |
|
Chlordiazepoxide |
1,500 |
Opiate2000 |
|
ClonazepamHCl |
800 |
Morphine |
2,000 |
|
Clobazam |
100 |
Codeine |
2,000 |
|
Clonazepam |
800 |
Ethylmorphine |
5,000 |
|
Clorazepatedipotassium |
200 |
Hydrocodone |
12,500 |
|
Delorazepam |
1,500 |
Hydromorphine |
5,000 |
|
Desalkylflurazepam |
400 |
Levorphanol |
75,000 |
|
Diazepam |
200 |
s-Monoacetylmorphine |
5,000 |
|
Estazolam |
2,500 |
Morphine3-b-D-glucuronide |
2,000 |
|
Flunitrazepam |
400 |
Norcodeine |
12,500 |
|
D,L-Lorazepam |
1,500 |
Normorphone |
50,000 |
|
|
|
Oxycodone |
25,000 |
|
Midazolam |
12,500 |
Oxymorphine |
25,000 |
|
Nitrazepam |
100 |
Procaine |
150,000 |
|
Norchlordiazepoxide |
200 |
Thebaine |
100,000 |
|
Nordiazepam |
400 |
Phencyclidine |
|
Temazepam |
100 |
Phencyclidine |
25 |
|
Trazolam |
2,500 |
4-Hydroxyphencyclidine |
12,500 |
|
Cocaine |
TricyclicAntidepressants |
|
Benzoylecgonine |
300 |
Notriptyline |
1,000 |
|
CocaineHCl |
750 |
Nordoxepine |
1,000 |
|
Cocaethylene |
12,500 |
|
|
|
Ecgonine |
32,000 |
|
|
|
Marijuana |
Trimipramiine |
3,000 |
|
11-nor-D9-THC-9-COOH |
50 |
Amitriptyline |
1,500 |
|
11-nor-D8-THC-9-COOH |
30 |
Promazine |
1,500 |
|
11-hydroxy-D9-Tetrahydrocannabinol |
2,500 |
Desipramine |
200 |
|
D8-Tetrahydrocannabinol |
7,500 |
Imipramine |
400 |
|
D9-Tetrahydrocannabinol |
10,000 |
Clomipramine |
12,500 |
|
Cannabinol |
10,000 |
Doxepine |
2,000 |
|
Cannabidiol |
100,000 |
Maprotiline |
2,000 |
|
Methadone |
Promethazine |
25,000 |
|
Methadone |
300 |
|
|
|
Doxylamine |
50,000 |
|
|
Considering the complexity of clinical urine
specimens and the possibility that various urine specimens
contain potentially interfering substances, we simulated
above situations by adding the potentially interfering
substances to a certain concentration as specimen. The
following components show no cross-reactivity when tested
with One Step Multi-Drug Urine Test Panel at a concentration
of 100 mg/ml.
|
Non Crossing-Reacting Compounds |
Acetophenetidin
Creatinine
Loperamide Quinidine
Nalidixic
acid Deoxycorticosterone
Meprobamate Quinine
Acetylsalicylic
acid Dextromethorphan
Methoxyphenamine Ranitidine
Aminopyrine
Diclofenac Nalidixic
acid Salicylic acid
Amoxicillin
Diflunisal
Naloxone Serotonin
Ampicillin
Digoxin
Naltrexone Sulfamethazine
L-Phenylephrine
Diphenhydramine Naproxen Sulindac
Apomorphine
L-y-Ephedrine
Niacinamide Tetracycline
Aspartame Ecgonine
methylester Nifedipine
Tetrahydrocortisone,
Atropine
Ethyl-p-aminobenzoate
Norethindrone 3-Acetate
Benzilic
acid
b-Estradiol D-Norpropoxyphene
Tetrahydrocortisone,
Benzoic
acid Estrone-3-sulfate
Noscapine (b-D-glucuronide)
Benzphetamine
Erythromycin
D,L-Octopamine Tetrahydrozoline
Bilirubin
Fenoprofen Oxalic
acid Thiamine
Deoxycorticosterone Furosemide
Oxolinic acid Thioridazine
Caffeine Gentisic
acid Oxymetazoline
D,L-Tyrosine
Hemoglobin
Papaverine Tolbutamide
Chloralhydrate
Hydralazine
Penicillin-G Triamterene
Chloramphenicol
Hydrochlorothiazide
Perphenazine Trifluoperazine
Chlorothiazide
Hydrocortisone
Phenelzine Trimethoprim
D,L-Chlolrpheniramine O-Hydroxyhippuric acid
L-Phenylephrine Tyramine
Chlorpromazine
3-Hydroxytyramine
b-Phenylethylamine D,L-Tryptophan
Chlorquine
D,L-Isoproterenol Phenylpropanolamine
Urine acid
Cholesterol
Isoxsuprine
Prednisone Verapamil
Clonidine
Ketamine
D,L-Propanolol Zomepirac
Cortisone
Ketoprofen
D-Propoxyphene
L-Cotinine
Labetalol D-Pseudoephedrine
From the results above, it
is clear that One Step Multi-Drug Urine Test Panel resists
well against interference from these substances.
|
BIBLIGRAPHY OF
SUGGESTED READING |
Baselt, R.C. Disposition
of Toxic Drugs and Chemicals in Man. Biomedical
Publications, Davis, CA, 1982.
Ellenhorn, M.J. and
Barceloux, D. G Medical Toxicology. Elservier Science
Publishing Company, Inc., New York, 1988
Gilman, A. G., and
Goodman, L. S. The Pharmacological Fluids, in Martin WR(ed):
Drug Addiction I, New York, Spring – Verlag, 1977.
Harvey, R.A., Champe, P.C.
Lippincotts Illustrated Reviews. Pharmacology. 91-95, 1992.
Hawwks RL, CN Chiang.
Urine Testing for drugs of Abuse. National Institute for
Drug Abuse (NIDA), Research Monography 73, 1986
Hofmann F.E., A Handbook
on Drug and Alcohol Abuse: The Biomedical Aspects, New York,
Oxford University Press, 1983.
McBay, A. J. Clin.
Chem. 33,33B-40B, 1987.
