Specimen Storage 5. A negative result may not necessarily indicate drug-free urine.

Negative results can be

HEALGEN AMP Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For long-term storage, specimens may
6.
obtained when drug is present but below the cut-off level of the test.
Test does not distinguish between drugs of abuse and certain medications.
be frozen and stored below -20°C. Frozen specimens should be thawed and mixed before testing.
One Step Amphetamine Test Strip (Urine) MATERIALS PERFORMANCE CHARACTERISTICS
Package Insert
Materials Provided Reproducibility
A rapid, one step test for the qualitative detection of Amphetamine in Reproducibility studies were carried out using commercially available stork solutions of the drug
Test strips
human urine. For in vitro diagnostic use only. Package insert analytes listed. Dilutions were made from the stork solution of each drug to the concentrations
INTENDED USE Materials Required But Not Provided specified in the following tables. The results are listed in the following tables.
The One Step Amphetamine Test Strip (Urine) is a lateral flow chromatographic immunoassay for Specimen collection
the detection of Amphetamine in human urine. Amphetamine (AMP)
container Timer
Amphetamine (AMP) Total number of
Test Calibrator Cut-off DIRECTIONS FOR USE conc.(ng/mL) Determinations Result Precision
Amphetamine (AMP) D-Amphetamine 1,000 ng/mL Allow the test strip, urine specimen, and/or controls to reach room temperature (15-30ºC) prior to No drug present 40 40 negative >99%
testing. 500 40 40 negative >99%
This assay provides only a preliminary analytical test result. A more specific alternate chemical 1. Bring the pouch to room temperature before opening it. Remove the test strip from the 750 40 40 negative >99%
method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass sealed pouch and use it as soon as possible. 1,000 40 40 positive >99%
spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and 2. With arrows pointing toward the urine specimen, immerse the test strip vertically in the
1,500 40 40 positive >99%
professional judgment should be applied to any drug of abuse test result, particularly when urine specimen for at least 10-15 seconds. Do not pass the maximum line (MAX) on the test
preliminary positive results are used. strip when immersing the strip. See the illustration below.
SUMMARY 3. Place the test strip on a non-absorbent flat surface, start the timer and wait for the red line(s) to Analytical Sensitivity
appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.
® A drug-free urine pool was spiked with drugs to the concentrations at ± 50% cut-off and ±
Amphetamine is a Schedule II controlled substance available by prescription (Dexedrine ) and is Test Results
also available on the illicit market. Amphetamines are a class of potent sympathomimetic agents 25% cut-off. The results are summarized below.
with therapeutic applications. They are chemically related to the human body’s natural
AMP Percent of Visual Result
catecholamines: epinephrine and norepinephrine. Acute higher doses lead to enhanced stimulation Concentration n
of the central nervous system and induce euphoria, alertness, reduced appetite, and a sense of (ng/mL) Cut-off Negative Positive
increased energy and power. Cardiovascular responses to Amphetamines include increased blood
0 0 30 30 0
pressure and cardiac arrhythmias. More acute responses produce anxiety, paranoia, hallucinations,
and psychotic behavior. The effects of Amphetamines generally last 2-4 hours following use, and 500 -50% 30 30 0
the drug has a half-life of 4-24 hours in the body. About 30% of Amphetamines are excreted in the 750 -25% 30 27 3
urine in unchanged form, with the remainder as hydroxylated and deaminated derivatives. 1,000 Cut-off 30 17 13
The One Step Amphetamine Test Strip (Urine) is a rapid urine screening test that can be 1250 +25% 30 6 24
performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively 1500 +50% 30 0 30
detect elevated levels of Amphetamine in urine. The One Step Amphetamine Test Strip (Urine)
yields a positive result when Amphetamines in urine exceed 1,000 ng/mL.
Analytical Specificity
PRINCIPLE
The following table lists the concentration of compounds (ng/mL) that were detected
The One Step Amphetamine Test Strip (Urine) is a rapid chromatographic immunoassay based on positive in urine by the One Step Amphetamine Test Strip (Urine) at a read time of 5 minutes.
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. INTERPRETATION OF RESULTS Drug Concentration (ng/ml)
During testing, a urine specimen migrates upward by capillary action. Amphetamine, if present in AMPHETAMINE (AMP)
(Please refer to the illustration above)
the urine specimen below 1,000ng/mL, will not saturate the binding sites of the antibody coated d-amphetamine 1,000
NEGATIVE:* Two lines appear. One red line should be in the control region (C), and another
particles in the test strip. The antibody coated particles will then be captured by immobilized D,l-amphetamine 1,000
apparent red or pink line should be in the test region (T). This negative result indicates that the
Amphetamine conjugate and a visible colored line will show up in the test line region. The colored l-amphetamine 20,000
Amphetamine concentration is below the detectable level (1,000ng/mL).
line will not form in the test line region if the Amphetamine level exceeds 1,000ng/mL because it Phentermine 1,250
*NOTE: The shade of red in the test line region (T) may vary, but it should be considered negative
will saturate all the binding sites of anti-Amphetamine antibodies.
A drug-positive urine specimen will not generate a colored line in the test line region, while a drug-negative urine
whenever there is even a faint pink line. (+/-)-Methylenedioxyamphetamine (MDA) 1,500
POSITIVE: One red line appears in the control region (C). No line appears in the test region (T). This
specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line
positive result indicates that the Amphetamine concentration exceeds the detectable level (1,000ng/mL).
region. To serve as a procedural control, a colored line will always appear at the control line region indicating that
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are Effect of Urinary Specific Gravity
proper volume of specimen has been added and membrane wicking has occurred.
the most likely reasons for control line failure. Review the procedure and repeat the test using a new test
REAGENTS Fifteen (15) urine specimens with specific gravity ranging from 1.001 to 1.032 were spiked with 500
strip. If the problem persists, discontinue using the lot immediately and contact your local distributor.
ng/mL and 750 ng/mL of Amphetamine respectively. The One Step Amphetamine Test Strip (Urine)
The test strip contains mouse monoclonal anti-Amphetamine antibody-coupled particles and was tested in duplicate using the fifteen neat and spiked urine specimens. The results
Amphetamine-protein conjugate. A goat antibody is employed in the control line system. QUALITY CONTROL demonstrate that varying ranges of urinary specific gravity do not affect the test results.
PRECAUTIONS A procedural control is included in the test. A red line appearing in the control region (C) is Effect of Urinary pH
For in vitro diagnostic use only. Do not use after the expiration
considered an internal procedural control. It confirms sufficient specimen volume, adequate
The pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in 1 pH unit
membrane wicking and correct procedural technique.
date. The test strip should remain in the sealed pouch until use. increments and spiked with Amphetamine to 500ng/mL and 1,250ng/mL. The spiked, pH-adjusted
Control standards are not supplied with this kit; however, it is recommended that positive and
All specimens should be considered potentially hazardous and handled in the same manner as urine was tested with the One Step Amphetamine Test Strip (Urine) in duplicate. The results
negative controls be tested as good laboratory testing practice to confirm the test procedure
an infectious agent. and to verify proper test performance. demonstrate that varying ranges of pH do not interfere with the performance of the test.
The used test strip should be discarded according to federal, state and local regulations. Cross-Reactivity
LIMITATIONS
STORAGE AND STABILITY A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free
1. The One Step Amphetamine Test Strip (Urine) provides only a qualitative, preliminary
The kit can be stored at room temperature or refrigerated (2-30°C). The test strip is stable through analytical result. A secondary analytical method must be used to obtain a confirmed result. urine or Amphetamine positive urine. The following compounds show no cross-reactivity when tested with
the expiration date printed on the sealed pouch. The test strip must remain in the sealed pouch 1,2 the One Step Amphetamine Test Strip (Urine) at a concentration of 100 g/mL.
Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.
until use. DO NOT FREEZE. Do not use beyond the expiration date. 2. It is possible that technical or procedural errors, as well as other interfering substances in
SPECIMEN COLLECTION AND PREPARATION the urine specimen may cause erroneous results.
3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous Non Cross-Reacting Compounds
Urine Assay results regardless of the analytical method used. If adulteration is suspected, the test 4-Acetamidophenol Acetophenetidin
The urine specimen must be collected in a clean and dry container. Urine collected at any time of should be repeated with another urine specimen. N-Acetylprocainamide Acetylsalicylic acid
4. A positive result indicates presence of the drug or its metabolites but does not indicate level Aminopyrine Amitriptyline
the day may be used. Urine specimens exhibiting visible particles should be centrifuged, filtered,
or allowed to settle to obtain clear specimen for testing. of intoxication, administration route or concentration in urine. Amobarbital Amoxicillin
Ampicillin L-Ascorbic acid
Apomorphine Aspartame
Atropine Benzilic acid
Benzoic acid Benzoylecgonine
Benzphetamine* Bilirubin
D/L-Brompheniramine Caffeine
Cannabidiol Cannabinol
Chloralhydrate Chloramphenicol
Chlordiazepoxide Chlorothiazide
D/L-Chloropheniramine Chlorpromazine
Chloroquine Cholesterol
Clomipramine Clonidine
Cocaine hydrochloride Codeine
Cortisone L-Cotinine
Creatinine Deoxycorticosterone
Dextromethorphan Diazepam
Diclofenac Diflunisal
Digoxin Diphenhydramine
Doxylamine Ecgonine hydrochloride
Ecgonine methylester [1R,2S] (-) Ephedrine
L-Ephedrine (-) Y Ephedrine
Erythromycin b-Estradiol
Estrone-3-sulfate Ethyl-p-aminobenzoate
Fenfluramine Fenoprofen
Furosemide Gentisic acid
Hemoglobin Hydralazine
Hydrochlorothiazide Hydrocodone
Hydrocortisone p-Hydroxyamphetamine
O-Hydroxyhippuric acid p-OH-methamphetamine
3-Hydroxytyramine Ibuprofen
Imipramine D/L-Isoproterenol
Isoxsuprine Ketamine
Ketoprofen Labetalol
Levorphanol Loperamide
Maprotiline Meperidine
Meprobamate Methadone
Methylphenidate Morphine –3-b-glucuronide
Nalidixic acid Naloxone
Naltrexone Naproxen
Niacinamide Nifedipine
Norcodeine Norethindrone
D-Norpropoxyphene Noscapine
D/L-Octopamine Oxalic acid
Oxazepam Oxolinic acid
Oxycodone Oxymetazoline
Papaverine Penicillin-G
Pentazocine Pentobarbital
Perphenazine Phencyclidine
Phenelzine Phenobarbital
L-Phenylephrine Phenylpropanolamine
Prednisolone Prednisone
Procaine Promazine
Promethazine D/L-Propranolol
D-Propoxyphene D-Pseudoephedrine
Quindine Quinine
Rantidine Salicylic acid
Secobarbital Serotonin
Sulfamethazine Sulindac
Temazepam Tetracycline
Tetrahydrocortisone 3-acetate Tetrahydrocortisone(b-D-glucuronide)
Tetrahydrozoline Thebaine
Thiamine Thioridazine
Tolbutamine Triamterene
Trifluoperazine Trimethoprim
D/L-Tryptophan D/L-Tyrosine
Uric acid Verapamil
Zomepirac
BIBLIOGRAPHY
1. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 2nd Ed. Biomedical Publ., Davis, CA.
1982; 488
1. Hawks RL, CN Chiang. Urine Testing for Drugs of Abuse. National Institute for Drug Abuse
(NIDA), Research Monograph 73, 1986