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ACCU-TELL MULTI-DRUG URINE TEST (CE)
Declaration: As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Catalog No. Product Name Note ABT-DOA-E51 Multi-Drug 2 Urine Panel CE ABT-DOA-E44 Multi-Drug 3 Urine Panel CE ABT-DOA-E45 Multi-Drug 4 Urine Panel CE ABT-DOA-E31 Multi-Drug 5 Urine Panel CE ABT-DOA-E32 Multi-Drug 6 Urine Panel CE ABT-DOA-E73 Multi-Drug 7 Urine Panel CE ABT-DOA-E74 Multi-Drug 8 Urine Panel CE ABT-DOA-E75 Multi-Drug 9 Urine Panel CE ABT-DOA-E53 Multi-Drug 10 Urine Panel CE
Accu-Tell ® Rapid Multi-Drug Test Panel is an immunchromatographic test for the rapid and qualitative detection of up to 10 drug types and its major metabolites in human urine. The following drug types can be detected with the test:
Drug type Cut-off
AMP Amphetamine 1000 ng/ml
BAR Barbiturate 300 ng/ml
BZO Benzodiazepine 300 ng/ml
COC Benzoylecgonin/Cocaine 300 ng/ml
MAMP Methamphetamine 1000 ng/ml
MTD Methadone 300 ng/ml
MOR Morphine 300 ng/ml
THC 11-nor-Δ9-THC-9-COOH 50 ng/ml
MDMA Ecstasy 1000 ng/ml
TCA Tricyclic Antidepressants 1000 ng/ml
This assay provides only a preliminary analytical test result. A more specific alternative chemical method (GC or GC/MS) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The assay should not be used without proper supervision and is not intended for over the counter sales to lay persons. It is only for professional use.
Accu-Tell ® Rapid Multi-Drug Test Panel detects the most frequently used drugs simultaneously. In this connection, the cut-off is adjusted to the demands of the American National Institute on Drug Abuse (NIDA). Urine based screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method for screening urine for drugs of abuse. Accu-Tell ® Rapid Multi-Drug Test Panel is based on the principle of the highly specific immunochemical reactions of antigens and antibodies which are used to detect drugs resp. its metabolites in human urine. The following drugs are detected with this test:
Amphetamine:
Amphetamines (amphetamine, methamphetamine, and the structurally related “designer” drugs, e.g., “Ecstasy”) are sympathomimetic amines whose biological effects include potent central nervous system (CNS) stimulation, anorectic, hyperthermic, and cardiovascular properties. They are usually taken orally, intravenously, or by smoking. Amphetamines are readily absorbed from the gastrointestinal tract and are then either deactivated by the liver or excreted unchanged in the urine. Amphetamines increase the heart rate and blood pressure and suppress the appetite. Some studies indicate that heavy abuse may result in permanent damage to certain essential nerve structures in the brain.
Urine based screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method for screening urine for drugs of abuse. The Drug Screen AMP is based on the principle of the highly specific immunochemical reactions of antigens and antibodies which are used for the analysis of specific compounds in biological fluids. This test is a rapid, visual, competitive immunoassay that can be used for the qualitative detection of amphetamine in human urine at 1000 ng/ml cut-off concentration.
Barbiturate:
Barbiturates are a class of central nervous system depressants. Phenobarbital is a long acting barbiturate derivative that has been used as a daytime sedative and very extensively as an anti-convulsant. Pentobarbital and Secobarbital are two examples of short acting barbiturate sedatives. Abuse of barbiturates can lead not only to respiratory collapse, coma and even death. Barbiturates are taken orally, rectally, or by intravenous and intramuscular injection. Short acting barbiturates will generally be excreted in urine as metabolites, while the long-acting barbiturates will primarily appear unchanged.
Urine based screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method for screening urine for drugs of abuse. The Drug Screen BAR is based on the principle of the highly specific immunochemical reactions of antigens and antibodies which are used for the analysis of specific compounds in biological fluids. This test is a rapid, visual, competitive immunoassay that can be used for the qualitative detection of barbiturates, in human urine at 300 ng/mL cut-off concentration.
Benzodiazepines:
Benzodiazepines are the most widely used anxialytic drugs. They are used extensively as anti-anxiety agents, hypnotics, muscle relaxants and anti-convulsants. They are taken orally or sometimes by injection. Benzodiazepines are metabolized in the liver. Some metabolites of benzodiazepines also exhibit pharmacological activities. Benzodiazepines and metabolites are excreted into the urine. Their use can result in drowsiness and confusion. Benzo-diazepines potentiate alcohol and other CNS depressants. Psychological and physical dependence on benzodiazepines can develop if high doses of the drug are given over a prolonged period. 6,7
Urine based screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method for screening urine for drugs of abuse. The Drug Screen BZO is based on the principle of the highly specific immunochemical reactions of antigens and antibodies which are used for the analysis of specific compounds in biological fluids. This test is a rapid, visual, competitive immunoassay that can be used for the qualitative detection of benzodiazepines in human urine at 300 ng/ml cut-off concentration.
Benzoylecgonine/ Cocaine:
Derived from leaves of coca plant, cocaine is a potent central nervous system stimulant and a local anesthetic. Among the psychological effects induced by using cocaine are euphoria, confidence and a sense of increased energy, accompanied by increased heart rate, dilation of the pupils, fever, tremors and sweating. Cocaine is excreted in urine primarily as benzoylecgonine in a short period of time. Benzoylecgonine has a biological half-life of 5 to 8 hours, which is much longer than that of cocaine (0.5 to 1.5 hours), and can be generally detected for 24 to 60 hours after cocaine use.
Urine based screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method for screening urine for drugs of abuse. The Drug Screen COC is based on the principle of the highly specific immunochemical reactions of antigens and antibodies which are used for the analysis of specific compounds in biological fluids. This test is a rapid, visual, competitive immunoassay that can be used for the qualitative detection of benzoylecgonine, the major metabolite of cocaine, in human urine.
Maijuana/THC
Marijuana is a hallucinogenic agent derived from the flowering portion of the hemp plant. Smoking is the primary method of use of marijuana/cannabis. Higher doses used by abusers produce central nervous system effects, altered mood and sensory perceptions, loss of co-ordination, impaired short-term memory, anxiety, paranoia, depression, confusion, hallucinations and increased heart rate. A tolerance to the cardiac and psychotropic effects can occur, and withdrawal syndrome produces restlessness, insomnia, anorexia and nausea.
When marijuana is ingested, the drug is metabolised by the liver. The primary urinary metabolite of marijuana is 11-nor- 9-THC-9-carboxylic acid, and its glucuronide. This means that the presence of detected cannabinoids, including the primary carboxyl metabolite, in the urine indicate marijuana/cannabis use.
Urine based screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method for screening urine for drugs of abuse. The Drug Screen THC is based on the principle of the highly specific immunochemical reaction of antigens and antibodies which are used for the analysis of specific compounds in biological fluids. This test is a rapid, visual, competitive immunoassay that can be used for the qualitative detection of 11-nor- 9-THC-9-carboxylic acid in human urine at a 50 ng/mL cut-off concentration.
Methadone:
Methadone is a synthetic analgesic drug that is originally used in the treatment of narcotic addicts. Among the psychological effects induced by using methadone are analgesia, sedation and respi-ratory depression. Overdose of methadone may cause coma or even death. It is administered orally or intravenously and is metabolized in the liver. The kidneys are a major route of methadone excretion. Methadone has a biological half-life of 15-60 hours.
Urine based screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method for screening urine for drugs of abuse. The Drug Screen MTD is based on the principle of the highly specific immunochemical reactions of antigens and antibodies which are used for the analysis of specific compounds in biological fluids. This test is a rapid, visual, competitive immunoassay that can be used for the qualitative detection of methadone in human urine.
Methamphetamine:
Methamphetamine, amphetamine, and metabolites are potent sympathomimetic agents. Acute higher doses lead to enhanced stimulation of the central nervous system and include euphoria, alertness, and a sense of increased energy and power. More acute responses produce anxiety, paranoia, psychotic behavior, and cardiac dysrhythmias. The pattern of psychosis which may appear at high doses may be indistinguishable from schizophrenia.
Methamphetamine is excreted in urine as amphetamine and oxidized as deaminated and hydroxylated derivatives. However, 40% of methamphetamine is excreted unchanged. Thus the presence of the parent compound in the urine indicates methamphetamine use.
Urine based screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method for screening urine for drugs of abuse. The Drug Screen M-AMP is based on the principle of the highly specific immunochemical reactions of antigens and antibodies which are used for the analysis of specific compounds in biological fluids. This test is a rapid, visual, competitive immunoassay that can be used for the qualitative detection of methamphetamine in human urine at 1000 ng/mL cut-off concentration.
Opiate/Morphine:
The opiates such as heroin, morphine, and codeine are derived from the resin of opium poppy. Heroin is quickly metabolized to morphine. Thus, morphine and morphine glucuronide might both be found in the urine of a person who has taken only heroin. The body also changes codeine to morphine. Thus the presence of morphine (or the metabolite, morphine glucuronide) in the urine indicates heroin, morphine and/or codeine use.
Urine based screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method for screening urine for drugs of abuse. The Drug Screen MOR is based on the principle of the highly specific immunochemical reactions of antigens and antibodies which are used for the analysis of specific compounds in biological fluids. This test is a rapid, visual, competitive immunoassay that can be used for the qualitative detection of morphine in human urine at 300 ng/ml cut-off concentration.
MDMA:
MDMA (ECTSASY) are the central nervous system stimulating drugs. They have addictive effects leading to substance abuse. They may induce alertness, increased energy, reduced hunger and overall feeling of well being. Ecstasy (ECTSASY) appear in the urine within three hours after administration (any type) and be present for 24-48 hours after the last dose2,3,4. Overdose and extended usage of Ecstasy (ECTSASY) may lead to substance abuse, which may cause severe and/or permanent damage to the human nerve system.
Tricyclic Antidepressants:
Tricyclic antidepressants, (commonly called TCAs) have been prescribed since the 1950s for depression. They are the oldest antidepressants we use today. Until recently TCAs were the clear first choice of physicians for the vast majority of people with major depressive disorder. Examples of TCAs are: imipramine (Tofranil), amitriptyline (Elavil) and nortriptyline (Pamelor). TCAs work by raising the levels of serotonin and norepinephrine in the brain by slowing the rate of reuptake, or reabsorption, by nerve cells. It may take several weeks to see the desired result. Tricyclic antidepressant (TCA) overdose remains the leading cause of death from intentional drug overdose. Cardiac arrhythmias and hypotension are the major contributors of death in TCA overdose. Much of the cardiotoxicity from TCAs results from quinidine-like actions on the cardiac action potential and a negative inotropic action. Glucagon has been shown to reverse the depression in cardiac contractility, blood pressure and heart rate in quinidine toxicity. The Drug Screen TCA is based on the principle of the highly specific immunochemical reactions of antigens and antibodies which are used for the analysis of specific compounds in biological fluids. This test is a rapid, visual, competitive immu-noassay that can be used for the qualitative detection of TCA´s in human urine.
Accu-Tell ® Rapid Multi-Drug Test Panel is an immunoassay in which a chemically labelled drug (drug conjugate) competes with the drug which may be present in urine for limited antibody binding sites. The test device contains membrane strips which are pre-coated with drug conjugate on the test band (T). A red colored anti-colloidal gold conjugate pad is placed at the right end of the membrane. After dipping into urine the gold-conjugates move upward chromatographically by capillary action and the antibodies get to the test region. If there is no drug molecule in the urine the antibody gold conjugate attaches to the drug conjugate to form a visible line. Therefore, the formation of a visible precipitant in the test zone occurs when the test urine is negative for the drug. When the drug is present in the urine, the drug/metabolite antigen competes with the drug conjugate on the test band region for limited antibody sites. When sufficient concentration of the drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored antibody-colloidal gold conjugate to the drug conjugate zone on the test band region. Therefore, absence of the colored band on the test region indicates a positive result. A control band with a different antigen/antibody reaction is also added to the immunochromatographic membrane strip at the control region ( C ) to indicate that the test has been performed properly. This control line should always appear, regardless of the presence of drug and metabolite. This means that negative urine will produce two colored bands, and positive urine will produce only one band. The presence of this colored band in the control region therefore serves as 1) verification that sufficient volume has been added, and 2) that proper flow was obtained.
The test kit is to be stored refrigerated or at room temperature (2-30 °C) in the sealed pouch for the duration of the shelf life.
1. For In Vitro use only
2. For professional use only
3. Urine specimens may be potentially infectious. Proper handling and disposal methods should be established.
4. Avoid cross-contamination of urine samples by using a new specimen collection container and specimen pipette for each urine sample.
Accu-Tell ® Rapid Multi-Drug Test Panel is formulated for use with urine specimens. Fresh urine does not require any special handling or pretreatment. Urine samples should be collected such that testing can be performed as soon as possible after the specimen collection, preferably during the same day. The specimen may be refrigerated at 2-8°C for 2 days, or frozen at -20°C for a lon-ger period of time. Specimens that have been refrigerated must be equilibrated to room temperature prior to testing. Specimens previously frozen must be thawed, equilibrated to room tempera-ture, and mixed thoroughly prior to testing.
Note: Urine specimens and all materials coming in contact with them should be handled and disposed of as if capable of transmitting infection. Avoid contact with skin by wearing gloves and proper laboratory attire.
Review “Specimen Collection“ instructions. Test device, patient’s samples, and controls should be brought to room temperature (20-30°C) prior to testing. Do not open pouches until ready to perform the assay.
Remove the test device from its protective pouch and label the device with patient or control/identification.
1. Remove the protective cap form the test device and hold the absorbent strips into the urine sample for at least 10 seconds. Be aware that the urine does not come into contact with the part of the test that is marked with MAX. If the urine comes into direct contact with the open test window, the test gets invalid.
2. Only remove the test strips out of the urine sample when you can see a control line at every single parameter. At least wait till you can see red color on every test window. This assures that enough urine has been absorbed for the correct performance of the test.
3. Read the results after 10 minutes or at the latest after 15 minutes as follows:
Negative:
Two colored lines appear in the viewing window. The line in the test region (T) is the drug probe line; the line on the control region (C) is the control line, which is used to indicate proper performance of the device.
The color intensity of the test line may be weaker or stronger than that of the control line.
Positive:
Only one colored line appears in the control region (C). The absence of a test line indicates a positive result.
Important Note:
Not all parameters have to be positive at the same time in one test. Please look at every parameter individually.
Invalid:
If no line appears in the control region, the test or rather the respective parameter is invalid and should be repeated.
Note:
A very faint line in the test region indicates that the respective drug in the sample is near the cut-off level of the test. These samples should be re-tested or confirmed with a more specific method before a positive determination is made.
If only one parameter (e.g. BZO) does not show a control line, you only have to retest the respective parameter with a single test.
1. The assay is designed for use with human urine only.
2. A positive result with any of the tests indicates the presence of a drug/metabolite only, and does not indicate or measure intoxication.
3. There is a possibility that technical or procedural errors as well as other substances and factors not listed may interfere with the test and cause false results. See SPECIFICITY for lists of substances that will produce positive results or that do not interfere with test performance.
4. If it is suspected that the samples have been mislabeled or tampered with, a new specimen should be collected and the test should be repeated.
Good laboratory practice recommends the use of control materials to ensure proper kit performance. Quality control specimens are available from commercial sources. When testing the positive and negative controls, use the same assay procedure as with a urine specimen.
A) Sensitivity
We obtained for every single parameter about 60 positive urine samples from clinical laboratories. The exact concentration of the respective drugs was detected in advanced via GC/MS or HPLC. Furthermore, 100 negative urine samples have been tested. The following results have been obtained:
B) Reproducibility
The accuracy was determined by spiking. In this connection, all concentrations 50% below the cut-off led to negative results and all concentrations 50% above the cut-off resulted in positive results.
C) Specificity
The specificity for the Drug Screen Multi 10 Device Test was tested by adding various drugs, drug metabolites, and other compounds that are likely to be present in urine. All compounds were prepared in drug-free normal human urine.
The following compounds were positive on the Drug Screen Multi 10 Device Test:
Compounds Concentrations (ng/ml)
Amphetamine
D-Amphetamine 1,000
L-Amphetamine 10,000
(+/-)3,4-metylenedioxy-
amphetamine (MDA) 5,000
Benzodiazepine
Oxazepam 300
Alprazolam 1,500
Bromazepam 800
Chlordiazepoxid 3,000
Clobazam 2,000
Clonazepam 5,000
Chlorazepam 1,000
Delorazepam 6,000
Diazepam 1,500
Estazolam 3,000
Flunitrazepam 10,000
Flurazepam 3,000
Lorazepam 15,000
Lormetazepam 10,000
Medazepam 20,000
Nitrozepam 10,000
Nordiazepam 1,000
Prazepam 10,000
Temazepam 1,500
Triazolam 15,000
Cocaine
Benzoylecgonine 300
Cocaine 300
Methamphetamine
(+)-Methamphetamine 1,000
D-Amphetamine 50,000
Chloroquine 50,000
(+/-)-Ephedrine 50,000
(-)-Methamphetamine 25,000
Mephentermine 50,000
(+/-)3,4-methylenedioxymeth-
amphetamin(MDMA) 2,000
b-Phenylethylamine 50,000
Ranitidine 50,000
Trimethobenzamide 10,000
Methadone & Derivatives
Methadone 300
Doxylamine 50,000
2-ethylidene-1,5-dimethyl-3,3-
diphenylpyrolidine 50,000
Methadol 25,000
Morphine
Morphine 300
Codeine 300
Ethyl Morphine 300
Hydrocodone 5,000
Hydromorphone 5,000
Morphine-3-b-d-glucuronid 1,000
Thebaine 30,000
THC & Derivatives
11-nor-D9-THC-9-COOH 50
11-nor-D8-THC-9-COOH 50
11-hydroxy-D9-Tetrahydrocannabinol 2,500
D8-Tetrahydrocannabinol 7,500
D9-Tetrahydrocannabinol 10,000
Cannabinol 10,000
Cannabidiol 100,000
Barbiturate
Allobarbital 1,000
Alphenal 300
Amobarbital 1,000
Aprobarbital 300
Barbital 300
Butabarbital 300
Butalbital 2,000
Butethal 300
Pentobarbital 300
Phenobarbital 300
MDMA
MDMA 1,000
l-AMP 20,000
MAMP 1,500
MDA 3,000
TCA
Nortriptylin 1.000
Amitriptylin 1.000
Desipramin 600
Imipramin 600
Nordoxepin 1.000
Cyclobenzaprin 1.500
Clomipramin 5.000
Doxepin 3.000
Protriptylin 2.000
Perphenazin 75.000
Promazin 15.000
Trimipramin 2.000
With exception of the above, for the respective parameter listed positive-reacting drugs resp. drug metabolites, all following listed compounds reacted negative up to a concentration of 100 μg/ml.
Acetaminophen Acetone
Albumine Amoxaoine
Ampicilline Aspartame
Aspirine Atropine
Baclofene Benzocaine
Benzafibrate Billirubine
(+)Brompheniramine Caffeine
Dexamethasone Dexbrompheniramine
Dextromethorphane 4-Dimethylaminoantipyrine
Diphenhydramine 5,5-Diphenylhydantoine
Dopamine Ecgonine
Ecgonine Methyl Ester (-)-y-Ephedrine
(+)-y-Ephedrine (+/-)-Epinephrine
Erythromycine Ethanol
Fenofibrate Fentanyl
Fluoxetine Gemfibrozile
Glucose Guaicol Glyceryl Ether
DL-HomatropinHemoglobine Hemoglobine
Hydrochlorothizid Ibuprofen
(+/-)-Isoproterenol Ketamine
Lidocaine Maprotiline
Methanol Methaqualone
2-IN-morpholinolathanesaltonic acid Methylphenidat
(1R,2S)-(-)-N-Methyl-Ephedrine Naltrexone
Acetyl-Naphtaline (+)-Naproxen
(-)-Nicotine Nictotine acid
Noscapine Hydrochloride (+/-)-Norephedrine
Orphenadrine Oxalic acid
Pentazocine Penicillin-G
Phenothiazine Phenelzine
Pheniramine L-Phenylephrine
Primidone Promethazine
Procaine 2-Propylantan-acid
Pseudoephedrine d-Propoxyphene
Quinidine Quinine
Riboflavine Salicylic acid
Sodium – chloride Sulindac
Tenocyclidine Theophylline
Thioridazine cis-Thiothixen
D(+)-Trehalen Trifluoperazine
Vitamin C
1. Aniline O., Pittes, F. N., Phencyclidine (PCP): A review and perspectives. CRC Crit. Rex. Toxicol, 1982, 10, 145-177.
2. Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man. Biomedical Publications, Davis, CA, 1982.
3. Urine Testing for Drugs of Abuse, National Institute on Drug. Abuse (NIDA), Research Monograph 73, 1986.
4. Ellenhorn, M.J. and Barceloux, D.G. Medical Toxicology. Elsevier Science Publishing Company, Inc., New YOrk, 1988.
5. Fed. Register, Department of Health and Human Services, Mandatory Guidelines for Federal Workplace Drug Testing Programs, 53, 69,11970-11979, 1988.
6. Gilman, A. G., and Goodman, L. S. The Pharmacological Basis of Therapeutics, eds. MacMillan Publishing, New York NY, 1980.
7. Gorodetzkym, C. W., Detection of Drugs of Abuse in Biological Fluids, in Martin WR(ed): Drug Addiction I, New York, Spring – Verlag, 1977.
8. Greenblatt, D.J., Shader, R.I. Benxodiazepines in Clinical Practice. New York: Raven Press, 1974.
9. Harvey, R.A., Champe, P.C. Lippincotts Illustrated Reviews. Pharmacology. 91-95, 1992.
10. Hofmann F.E., A Handbook on Drug and Alcohol Abuse: The Biomedical Aspects, New York, Oxford University Press, 1983.
11. McBay, A. J. Clin. Chem. 33, 33B-40B, 1987.
The above information is just for reference. The actual technical specifications are subject to the insert provided with the product. |
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