Package Insert STORAGE AND STABILITY LIMITATIONS

HEALGEN AMP The kit can be stored at room temperature or refrigerated (2-30°C). The test strip is
stable through the expiration date printed on the sealed pouch. The test strip must
1. The One Step Amphetamine Test Cassette provides only a qualitative, preliminary
analytical result. A secondary analytical method must be used to obtain a confirmed
remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration result. Gas chromatography/mass spectrometry (GC/MS) is the preferred
Test Cassette date. confirmatory method.1,2
2. It is possible that technical or procedural errors, as well as other interfering substances
A rapid, one step test for the qualitative detection of Amphetamine in human urine. SPECIMEN COLLECTION AND PREPARATION
in the urine specimen may cause erroneous results.
For in vitro diagnostic use only. Urine Assay 3. Adulterants, such as bleach and/or alum, in urine specimens may produce
INTENDED USE The urine specimen must be collected in a clean and dry container. Urine collected at erroneous results regardless of the analytical method used. If adulteration is
The One Step Amphetamine Test Cassette is a lateral flow chromatographic any time of the day may be used. Urine specimens exhibiting visible particles should suspected, the test should be repeated with another urine specimen.
immunoassay for the detection of Amphetamine in human urine. be centrifuged, filtered, or allowed to settle to obtain clear specimen for testing. 4. A positive result indicates presence of the drug or its metabolites but does not
indicate level of intoxication, administration route or concentration in urine.
Test Calibrator Cut-off Specimen Storage
5. A negative result may not necessarily indicate drug-free urine. Negative results
Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For long-term
Amphetamine (AMP) D-Amphetamine 1000 ng/mL can be obtained when drug is present but below the cut-off level of the test.
storage, specimens may be frozen and stored below -20°C. Frozen specimens should be
6. Test does not distinguish between drugs of abuse and certain medications.
thawed and mixed before testing.
This assay provides only a preliminary analytical test result. A more specific PERFORMANCE CHARACTERISTICS
alternate chemical method must be used in order to obtain a confirmed MATERIALS
analytical result. Gas chromatography/mass spectrometry (GC/MS) is the
Materials Provided Reproducibility
preferred confirmatory method. Clinical consideration and professional
judgment should be applied to any drug of abuse test result, particularly when  Test Cassette Reproducibility studies were carried out using commercially available stork solutions of
preliminary positive results are used.  Disposable specimen droppers the drug analytes listed. Dilutions were made from the stork solution of each drug to the
SUMMARY  Package insert concentrations specified in the following tables. The results are listed in the following
Materials Required But Not Provided tables.
Amphetamine is a Schedule II controlled substance available by prescription
(Dexedrine®) and is also available on the illicit market. Amphetamines are a class of  Specimen collection container
Amphetamine (AMP) Total number of
potent sympathomimetic agents with therapeutic applications. They are chemically  Timer Result Precision
conc.(ng/mL) Determinations
related to the human body’s natural catecholamines: epinephrine and norepinephrine.
Acute higher doses lead to enhanced stimulation of the central nervous system and No drug present 40 40 negative >99%
induce euphoria, alertness, reduced appetite, and a sense of increased energy and DIRECTIONS FOR USE 500 40 40 negative >99%
power. Cardiovascular responses to Amphetamines include increased blood pressure Allow the test strip, urine specimen, and/or controls to reach room temperature 1,500 40 40 positive >99%
and cardiac arrhythmias. More acute responses produce anxiety, paranoia, (15-30ºC) prior to testing. 2,000 40 40 positive >99%
hallucinations, and psychotic behavior. The effects of Amphetamines generally last 2-4 1) Remove the test device from its foil wrapper by tearing along the slice (bring the
hours following use, and the drug has a half-life of 4-24 hours in the body. About 30% of container to the room temperature before opening to avoid condensation of moisture in
Amphetamines are excreted in the urine in unchanged form, with the remainder as Analytical Sensitivity
container). Label the device with patient or control identifications.
hydroxylated and deaminated derivatives. 2) Using the specimen dropper, withdraw the urine sample from the specimen cup and A drug-free urine pool was spiked with drugs to the concentrations at  50% cut-off and
The One Step Amphetamine Test Cassette is a rapid urine screening test that can be slowly dispense 3 drops (approximately 120uL) into the circular sample well, being  25% cut-off. The results are summarized below.
performed without the use of an instrument. The test utilizes a monoclonal antibody to careful not to overfill the absorbent pad.
selectively detect elevated levels of Amphetamine in urine. The One Step AMP Visual Result
3) Read results at 5 minutes. Percent of
Amphetamine Test Cassette yields a positive result when Amphetamines in urine Concentration n
DO NOT INTERPRET RESULT AFTER 10 MINUTES. Cut-off Negative Positive
exceed 1,000 ng/mL. (ng/mL)
0 0 30 30 0
PRINCIPLE
500 -50% 30 30 0
The One Step Amphetamine Test Cassette is a rapid chromatographic immunoassay 750 -25% 30 27 3
based on the principle of competitive binding. Drugs which may be present in the urine
1,000 Cut-off 30 17 13
specimen compete against the drug conjugate for binding sites on the antibody.
During testing, a urine specimen migrates upward by capillary action. Amphetamine, if 1,250 +25% 30 6 24
present in the urine specimen below 1,000ng/mL, will not saturate the binding sites of 1,500 +50% 30 0 30
the antibody coated particles in the test strip. The antibody coated particles will then be INTERPRETATION OF RESULTS
captured by immobilized Amphetamine conjugate and a visible colored line will show Analytical Specificity
up in the test line region. The colored line will not form in the test line region if the (Please refer to the illustration above)
NEGATIVE:* Two lines appear. One red line should be in the control region (C), and The following table lists the concentration of compounds (ng/mL) that were detected
Amphetamine level exceeds 1,000ng/mL because it will saturate all the binding sites of
another apparent red or pink line should be in the test region (T). This negative result positive in urine by The One Step Amphetamine Test Cassette (Urine) at a read time of 5
anti-Amphetamine antibodies.
indicates that the Amphetamine concentration is below the detectable level (300ng/mL). minutes.
A drug-positive urine specimen will not generate a colored line in the test line region,
while a drug-negative urine specimen or a specimen containing a drug concentration less *NOTE: The shade of red in the test line region (T) may vary, but it should be Drug Concentration (ng/ml)
than the cut-off will generate a line in the test line region. To serve as a procedural considered negative whenever there is even a faint pink line. AMPHETAMINE (AMP1000)
control, a colored line will always appear at the control line region indicating that proper POSITIVE: One red line appears in the control region (C). No line appears in the
d-amphetamine 1,000
volume of specimen has been added and membrane wicking has occurred. test region (T). This positive result indicates that the Amphetamine concentration
exceeds the detectable level (1,000ng/mL). D,l-amphetamine 1,000
REAGENTS INVALID: Control line fails to appear. Insufficient specimen volume or incorrect l-amphetamine 20,000
The test strip contains mouse monoclonal anti-Amphetamine antibody-coupled particles and procedural techniques are the most likely reasons for control line failure. Review the Phentermine 1,250
Amphetamine-protein conjugate. A goat antibody is employed in the control line system. procedure and repeat the test using a new test strip. If the problem persists, (+/-)-Methylenedioxyamphetamine (MDA) 1,500
discontinue using the lot immediately and contact your local distributor. (+/-)-4-Hydroxyamphetamine HCL 600
PRECAUTIONS
 For in vitro diagnostic use only. Do not use after the expiration date. QUALITY CONTROL
 The test strip should remain in the sealed pouch until use. Effect of Urinary Specific Gravity
 All specimens should be considered potentially hazardous and handled in the same A procedural control is included in the test. A red line appearing in the control region
(C) is considered an internal procedural control. It confirms sufficient specimen Fifteen (15) urine samples of normal, high, and low specific gravity ranges (1.005,
manner as an infectious agent.
volume, adequate membrane wicking and correct procedural technique. 1.015, 1.030) were spiked with drugs at 50% below and 50% above cut-off levels
 The used test strip should be discarded according to federal, state and local
Control standards are not supplied with this kit; however, it is recommended that respectively. The One Step Amphetamine Test Cassette was tested in duplicate using
regulations.
positive and negative controls be tested as good laboratory testing practice to confirm ten drug-free urine and spiked urine samples. The results demonstrate that varying
the test procedure and to verify proper test performance. ranges of urinary specific gravity do not affect the test results.
 Effect of Urinary pH Promethazine D/L-Propranolol
D-Propoxyphene D-Pseudoephedrine
The pH of an aliquoted negative urine pool was adjusted to pH ranges of 4.0, 4.5, 5.0, Quindine Quinine
6.0 and 9.0, and spiked with drugs at 50% below and 50% above cut-off levels. The
Rantidine Salicylic acid
spiked, pH-adjusted urine was tested with The One Step Amphetamine Test Cassette.
Secobarbital Serotonin
The results demonstrate that varying ranges of pH do not interfere with the
Sulfamethazine Sulindac
performance of the test.
Temazepam Tetracycline
Cross-Reactivity Tetrahydrocortisone 3-acetate
Tetrahydrocortisone(-D-glucuro
A study was conducted to determine the cross-reactivity of the test with compounds in
nide)
either drug-free urine or Amphetamine positive urine. The following compounds show
no cross-reactivity when tested with The One Step Amphetamine Test Cassette (Urine) Tetrahydrozoline Thebaine
Thiamine Thioridazine
at a concentration of 100 g/mL.
Tolbutamine Triamterene
Trifluoperazine Trimethoprim
Non Cross-Reacting Compounds D/L-Tryptophan D/L-Tyrosine
Uric acid Verapamil
4-Acetamidophenol Acetophenetidin
Zomepirac
N-Acetylprocainamide Acetylsalicylic acid
Aminopyrine Amitriptyline BIBLIOGRAPHY
Amobarbital Amoxicillin
1. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 2nd Ed.
Ampicillin L-Ascorbic acid
Biomedical Publ., Davis, CA. 1982; 488
Apomorphine Aspartame
2. Hawks RL, CN Chiang. Urine Testing for Drugs of Abuse. National Institute for
Atropine Benzilic acid
Drug Abuse (NIDA), Research Monograph 73, 1986
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 -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--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